ZOLPIDEM TARTRATE- zolpidem tartrate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3)] . Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data]. Oral ad
Product summary:
Product: 63629-8163 NDC: 63629-8163-1 30 TABLET in a BOTTLE Product: 63629-8200 NDC: 63629-8200-1 30 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8163-1, 63629-8200-1

ZOLPIDEM TARTRATE- zolpidem tartrate tablet

Bryant Ranch Prepack

----------

MEDICATION GUIDE

Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV

Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each time

you get a refill. There may be new information. This Medication Guide does not take the place of talking to

your healthcare provider about your medical condition or treatment.

What is the most important information I should know about zolpidem tartrate tablets?

Do not take more zolpidem tartrate tablets than prescribed.

Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7 to 8 hours)

before you must be active again.

Take zolpidem tartrate tablets right before you get in bed, not sooner.

Zolpidem tartrate tablets may cause serious side effects, including:

After taking zolpidem tartrate tablets, you may get up out of bed while not being fully awake and do

an activity that you do not know you are doing. The next morning, you may not remember that you

did anything during the night. You have a higher chance for doing these activities if you drink alcohol

or take other medicines that make you sleepy with zolpidem tartrate tablets. Reported activities

include:

o driving a car ("sleep-driving")

o making and eating food

o talking on the phone

o having sex

o sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after

taking zolpidem tartrate tablets.

Do not take zolpidem tartrate tablets if you:

drank alcohol that evening or before bed

took another medicine to help you sleep

What are zolpidem tartrate tablets?

Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults

for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years.

Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused or

lead to dependence. Keep zolpidem tartrate tablets in a safe place to prevent misuse and

abuse. Selling or giving away zolpidem tartrate tablets may harm others, and is against the

law. Tell your healthcare provider if you have ever abused or have been dependent on

alcohol, prescription medicines or street drugs.

Who should not take zolpidem tartrate tablets?

Do not take zolpidem tartrate tablets if you are allergic to zolpidem or any other ingredients in

zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in

zolpidem tartrate tablets.

Do not take zolpidem tartrate tablets if you have had an allergic reaction to drugs containing

zolpidem, such as zolpidem tartrate CR tablets, Edluar, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include:

swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking zolpidem tartrate tablets?

Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell your

healthcare provider about all of your health conditions, including if you:

have a history of depression, mental illness, or suicidal thoughts

have a history of drug or alcohol abuse or addiction

have kidney or liver disease

have a lung disease or breathing problems

are pregnant, planning to become pregnant. Talk to your healthcare provider about the risk to your

unborn baby if you take zolpidem tartrate tablets.

Using zolpidem tartrate tablets in the last trimester of pregnancy may cause breathing difficulties or

excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual),

troublebreathing, or limpness in the newborn if zolpidem tartrate tablets is taken late in pregnancy.

are breastfeeding or plan to breastfeed.

Zolpidem tartrate tablets passes into your breast milk. Talk to your healthcare provider about the best

way to feed your baby while you take zolpidem tartrate tablets.

Zolpidem tartrate tablets can pass into your breast milk. It is not known if zolpidem tartrate tablets will harm

your baby. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem

tartrate tablets.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription

medicines, vitamins and herbal supplements.

Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate

tablets with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and

pharmacist each time you get a new medicine.

How should I take zolpidem tartrate tablets?

See "What is the most important information I should know about zolpidem tartrate tablets?"

Take zolpidem tartrate tablets exactly as prescribed. Only take 1 zolpidem tartrate tablet a night if

needed.

Do not take zolpidem tartrate tablets if you drank alcohol that evening or before bed.

You should not take zolpidem tartrate tablets with or right after a meal. Zolpidem tartrate tablets

may help you fall asleep faster if you take it on an empty stomach.

Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may

mean that there is another condition causing your sleep problem.

If you take too much zolpidem tartrate tablets or overdose, get emergency treatment.

What are the possible side effects of zolpidem tartrate tablets?

Zolpidem tartrate tablets may cause serious side effects, including:

getting out of bed while not being fully awake and do an activity that you do not know you are

doing. See " What is the most important information I should know about zolpidem tartrate tablets? "

abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than

normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or

actions.

memory loss

anxiety

severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing.

Get emergency medical help if you get these symptoms after taking zolpidem tartrate tablets.

falls, which may lead to severe injuries

Call your healthcare provider right away if you have any of the above side effects or any other side effects

that worry you while using zolpidem tartrate tablets.

The most common side effects of zolpidem tartrate tablets are:

drowsiness

dizziness

diarrhea

grogginess or feeling as if you have been drugged

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

trouble sleeping

nausea

flushing

lightheadedness

uncontrolled crying

vomiting

stomach cramps

panic attack

nervousness

stomach area pain

These are not all the side effects of zolpidem tartrate tablets. Ask your healthcare provider or pharmacist for

more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–

1088.

How should I store zolpidem tartrate tablets?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP

Controlled Room Temperature].

Keep zolpidem tartrate tablets and all medicines out of reach of children.

General Information about the safe and effective use of zolpidem tartrate tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

zolpidem tartrate tablets for a condition for which it was not prescribed. Do not share zolpidem tartrate

tablets with other people, even if they have the same symptoms that you have. It may harm them and it is

against the law.

This Medication Guide summarizes the most important information about zolpidem tartrate tablets. If you

would like more information, talk with your healthcare provider. You can ask your healthcare provider or

pharmacist for information about zolpidem tartrate tablets that are written for healthcare professionals.

For more information, call 1-800-912-9561.

What are the ingredients in zolpidem tartrate tablets?

Active Ingredient: Zolpidem tartrate, USP

Inactive Ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate,

polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also

contains ferric oxide yellow.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8075161 Revised April 2019

Revised: 8/2019

Document Id: a5ae0f9f-4a80-4279-9ee2-17084a9565a3

34391-3

Set id: 7e304dd2-8a5b-4367-aab2-56fdd883402a

Version: 2

Effective Time: 20190807

Bryant Ranch Prepack

ZOLPIDEM TARTRATE- zolpidem tartrate tablet

Bryant Ranch Prepack

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely

and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS.

ZOLPIDEM tartrate (USP-CIV) tablets, for oral use

Initial U.S. Approval: 1992.

RECENT MAJOR CHANGES

Warnings and Precautions, CNS Depressant Effects and Next-day Impairment ( 5.1)

02/2019

INDICATIONS AND USAGE

Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the

short-term treatment of insomnia characterized by difficulties with sleep initiation. (1)

DOSAGE AND ADMINISTRATION

Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily ( 2.1)

Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately

before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.1)

Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and

women ( 2.2)

Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate tablets ( 2.3)

The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal ( 2.4)

DOSAGE FORMS AND STRENGTHS

5 mg and 10 mg tablets. Tablets not scored. (3)

CONTRAINDICATIONS

Known hypersensitivity to zolpidem (4)

WARNINGS AND PRECAUTIONS

CNS-depressant effects: Impairs alertness and motor coordination. Instruct patients on correct use. ( 5.1)

Need to evaluate for comorbid diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use. ( 5.2)

Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if

such reactions occur. ( 5.3)

"Sleep-driving" and other complex behaviors while not fully awake. Risk increases with dose and use with other CNS

depressants and alcohol. Immediately evaluate any new onset behavioral changes. ( 5.4)

Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to

avoid intentional overdose. ( 5.5)

Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.6)

Hepatic Impairment: Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment. ( 5.7)

Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.8, 9.3)

ADVERSE REACTIONS

Most commonly observed adverse reactions were:

Short-term (<10 nights): Drowsiness, dizziness, and diarrheaShort-term (<10 nights): Drowsiness, dizziness, and diarrhea

Long-term (28 to 35 nights): Dizziness and drugged feelings ( ) Long-term (28 to 35 nights): Dizziness and drugged

feelings ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma, Inc. at 1-800-912-9561 or FDA at 1-

800-FDA-1088 or http://www.fda.gov/medwatch

DRUG INTERACTIONS

CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1, 7.1)

Imipramine: Decreased alertness observed ( 7.1)

Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1)

CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2)

Ketoconazole: Combination use may increase effect ( 7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ( 8.1)

Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after zolpidem

tartrate tablets administration. ( 8.2)

Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or

nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-

Deficit/Hyperactivity Disorder. ( 5.4, 8.4)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults

2.2 Special Populations

2.3 Use with CNS Depressants

2.4 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 CNS-Depressant Effects and Next-Day Impairment

5.2 Need to Evaluate for Comorbid Diagnoses

5.3 Severe Anaphylactic and Anaphylactoid Reactions

5.4 Abnormal Thinking and Behavioral Changes

5.5 Use in Patients with Depression

5.6 Respiratory Depression

5.7 Precipitation of Hepatic Encephalopathy

5.8 Withdrawal Effects

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 CNS-Active Drugs

7.2 Drugs that Affect Drug Metabolism via Cytochrome P450

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Gender Difference in Pharmacokinetics

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

10.1 Signs and Symptoms

10.2 Recommended Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynanamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Transient Insomnia

14.2 Chronic Insomnia

14.3 Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by

difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep

latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] .

The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal

assessments of sleep latency performed at the end of treatment.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and

either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8

hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be

increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose

increase the risk of next-day impairment of driving and other activities that require full alertness [see

Warnings and Precautions ( 5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg

once daily immediately before bedtime. Zolpidem tartrate tablets should be taken as a single dose and

should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower

in women.

2.2 Special Populations

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The

recommended dose of zolpidem tartrate in these patient is 5 mg once daily immediately before bedtime

[see Warnings and Precautions ( 5.1), Use in Specific Populations ( 8.5)].

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects.

The recommended dose of zolpidem tartrate tablets in these patients is 5 mg once daily immediately

before bedtime. Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may

contribute to encephalopathy [see Warnings and Precautions ( 5.7), Use in Specific Populations ( 8.7),

Clinical Pharmacology ( 12.3)].

2.3 Use with CNS Depressants

Sections or subsections omitted from the full prescribing information are not listed.

Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS-

depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.1)] .

2.4 Administration

The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

3 DOSAGE FORMS AND STRENGTHS

Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets

are not scored.

Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed

on one side and '5 MG' debossed on the other side.

Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo

debossed on one side and '10 MG' debossed on the other side.

4 CONTRAINDICATIONS

Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem.

Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3)] .

5 WARNINGS AND PRECAUTIONS

5.1 CNS-Depressant Effects and Next-Day Impairment

Zolpidem tartrate tablets, like other sedative-hypnotic drugs, has central nervous system (CNS)

depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids,

tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of

zolpidem tartrate tablets and of other concomitant CNS depressants may be necessary when zolpidem

tartrate tablets are administered with such agents because of the potentially additive effects. The use of

zolpidem tartrate tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or

the middle of the night is not recommended [see Dosage and Administration ( 2.3)].

The risk of next-day psychomotor impairment, including impaired driving, is increased if zolpidem

tartrate tablets are taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the

recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if

coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned

against driving and other activities requiring complete mental alertness if zolpidem tartrate tablets are

taken in these circumstances [see Dosage and Administration ( 2) and Clinical Studies ( 14.3)].

Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a

possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness,

blurred/double vision, reduced alertness, and impaired driving the morning after therapy. In order to

minimize this risk a full night of sleep (7 to 8 hours) is recommended.

Because zolpidem can cause drowsiness and a decreased level of consciousness, patients, particularly

the elderly, are at higher risk of falls.

5.2 Need to Evaluate for Comorbid Diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric

disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the

patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a

primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the

emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized

psychiatric or physical disorder. Such findings have emerged during the course of treatment with

sedative/hypnotic drugs, including zolpidem.

5.3 Severe Anaphylactic and Anaphylactoid Reactions

Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking

the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had

additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the

throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema

after treatment with zolpidem should not be rechallenged with the drug.

5.4 Abnormal Thinking and Behavioral Changes

Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics,

including zolpidem. Some of these changes included decreased inhibition (e.g., aggressiveness and

extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and

auditory hallucinations have been reported.

In controlled trials of zolpidem 10 mg taken at bedtime <1% of adults with insomnia reported

hallucinations. In a clinical trial, 7% of pediatric patients treated with zolpidem 0.25 mg/kg taken at

bedtime reported hallucinations versus 0% treated with placebo [see Use in Specific Populations ( 8.4)] .

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a

sedative-hypnotic, with amnesia for the event) have been reported in sedative-hypnotic─naive as well as

in sedative-hypnotic─experienced persons. Although behaviors such as "sleep-driving" have occurred

with zolpidem alone at therapeutic doses, the coadministration of zolpidem with alcohol and other CNS

depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the

maximum recommended dose. Due to the risk to the patient and the community, discontinuation of

zolpidem should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been

reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving,"

patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms

may also occur.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed

above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical

disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires

careful and immediate evaluation.

5.5 Use in Patients with Depression

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal

thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be

present in such patients and protective measures may be required. Intentional overdosage is more

common in this group of patients; therefore, the lowest number of tablets that is feasible should be

prescribed for the patient at any one time.

5.6 Respiratory Depression

Although studies with 10 mg zolpidem tartrate did not reveal respiratory depressant effects at hypnotic

doses in healthy subjects or in patients with mild to moderate chronic obstructive pulmonary disease

(COPD), a reduction in the Total Arousal Index, together with a reduction in lowest oxygen saturation

and increase in the times of oxygen desaturation below 80% and 90%, was observed in patients with

mild to moderate sleep apnea when treated with zolpidem compared to placebo. Since sedative-

hypnotics have the capacity to depress respiratory drive, precautions should be taken if zolpidem is

prescribed to patients with compromised respiratory function. Post marketing reports of respiratory

insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing

respiratory impairment, have been reported. The risk of respiratory depression should be considered

prior to prescribing zolpidem in patients with respiratory impairment including sleep apnea and

myasthenia gravis.

5.7 Precipitation of Hepatic Encephalopathy

Drugs affecting GABA receptors, such as zolpidem tartrate, have been associated with precipitation of

hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic

insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid

zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to

encephalopathy [see Dosage and Administration ( 2.2), Use in Specific Populations ( 8.7), Clinical

Pharmacology ( 12.3)].

5.8 Withdrawal Effects

There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt

discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and

Dependence ( 9.2, 9.3)] .

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the

labeling:

CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.1)]

Serious anaphylactic and anaphylactoid reactions [see Warnings and Precautions ( 5.3)]

Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions (

5.4)]

Withdrawal effects [see Warnings and Precautions ( 5.8)]

6.1 Clinical Trials Experience

Associated with Discontinuation of Treatment

Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S.

premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most

commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness

(0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign

trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with

discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia

(0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were

given zolpidem revealed that four of the seven discontinuations during double-blind treatment with

zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and

manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most Commonly Observed Adverse Reactions in Controlled Trials

During short-term treatment (up to 10 nights) with zolpidem tartrate tablets at doses up to 10 mg, the

most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically

significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem

patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with

zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use

of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness

(5%) and drugged feelings (3%).

Adverse Reactions Observed at an Incidence of ≥1% in Controlled Trials

The following tables enumerate treatment-emergent adverse reactions frequencies that were observed

at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and

at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators

were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms

for the purpose of establishing event frequencies. The prescriber should be aware that these figures

cannot be used to predict the incidence of side effects in the course of usual medical practice, in which

patient characteristics and other factors differ from those that prevailed in these clinical trials.

Similarly, the cited frequencies cannot be compared with figures obtained from other clinical

investigators involving related drug products and uses, since each group of drug trials is conducted

under a different set of conditions. However, the cited figures provide the physician with a basis for

estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the

population studied.

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials

involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to

and including 10 mg, the highest dose recommended for use.

Table 1 Incidences of Treatment-Emergent Adverse Experiences in Placebo Controlled Clinical

Trials Lasting up to 10 Nights (Percentage of patients reporting)

Body System

Adverse Event

Zolpidem

(≤10 mg)

(N=685)

Placebo

(N=473)

Central and Peripheral Nervous System

Headache

Drowsiness

Dizziness

Gastrointestinal System

Diarrhea

The following table was derived from results of three placebo-controlled long-term efficacy trials

involving zolpidem tartrate tablets. These trials involved patients with chronic insomnia who were

treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from

doses up to and including 10 mg, the highest dose recommended for use. The table includes only

adverse events occurring at an incidence of at least 1% for zolpidem patients.

Table 2 Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical

Trials Lasting up to 35 Nights (percentage of patients reporting)

Body System

Adverse Event

Zolpidem

(≤10 mg)

(N=152)

Placebo

(N=161)

Autonomic Nervous System

Dry mouth

Body as a Whole

Allergy

Back Pain

Reactions reported by at least 1% of patients treated with zolpidem tartrate tablets and at a greater frequency

than placebo.

Influenza-like symptoms

Chest pain

Cardiovascular System

Palpitation

Central and Peripheral Nervous System

Drowsiness

Dizziness

Lethargy

Drugged feeling

Lightheadedness

Depression

Abnormal dreams

Amnesia

Sleep disorder

Gastrointestinal System

Diarrhea

Abdominal pain

Constipation

Respiratory System

Sinusitis

Pharyngitis

Skin and Appendages

Rash

Dose Relationship for Adverse Reactions

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse

reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse

events.

Adverse Event Incidence Across the Entire Preapproval Database

Zolpidem tartrate tablets were administered to 3,660 subjects in clinical trials throughout the U.S.,

Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were

recorded by clinical investigators using terminology of their own choosing. To provide a meaningful

estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types

of untoward events were grouped into a smaller number of standardized event categories and classified

utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to

zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while

receiving zolpidem. All reported treatment-emergent adverse events are included, except those already

listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so

general as to be uninformative, and those events where a drug cause was remote. It is important to

emphasize that, although the events reported did occur during treatment with zolpidem tartrate tablets,

they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of

decreasing frequency using the following definitions: frequent adverse events are defined as those

occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to

1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Reactions reported by at least 1% of patients treated with zolpidem tartrate tablets and at a

greater frequency than placebo.

Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope.

Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased

saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare:

allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain,

restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina

pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial

infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia,

vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating,

dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness,

paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait,

abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia,

depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling,

manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder,

somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation,

dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis,

hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia,

lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa,

otitis media.

Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia,

increased SGOT.

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia,

hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle

weakness, sciatica, tendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast

neoplasm, breast pain.

Respiratory system: Frequent: upper respiratory infection, lower respiratory infection. Infrequent:

bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia,

laryngitis, pneumonia.

Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis,

injection-site inflammation, photosensitivity reaction, urticaria.

Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste

perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare:

acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary

retention.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of zolpidem tartrate

tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not

always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice

(i.e., bilirubin >2 x ULN, alkaline phosphatase ≥2 x ULN, transaminase ≥5 x ULN).

7 DRUG INTERACTIONS

7.1 CNS-Active Drugs

Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression.

Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment,

including impaired driving ability [see Warnings and Precautions ( 5.1)]. Zolpidem tartrate was evaluated

in healthy volunteers in single-dose interaction studies for several CNS drugs.

Imipramine, Chlorpromazine

Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20%

decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.

Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but

there was an additive effect of decreased alertness and psychomotor performance [see Clinical

Pharmacology ( 12.3)] .

Haloperidol

A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics

or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration

does not predict the absence of an effect following chronic administration [see Clinical Pharmacology (

12.3)] .

Alcohol

An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was

demonstrated [see Warnings and Precautions ( 5.1)] .

Sertraline

Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see Clinical

Pharmacology ( 12.3)] .

Fluoxetine

After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was

observed. There was no evidence of an additive effect in psychomotor performance [see Clinical

Pharmacology ( 12.3)] .

7.2 Drugs that Affect Drug Metabolism via Cytochrome P450

Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of

drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known.

CYP3A4 Inducers

Rifampin

Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of

zolpidem. Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is

not recommended [see Clinical Pharmacology ( 12.3)] .

St. John's wort

Use of St. John's wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of

zolpidem and is not recommended.

CYP3A4 Inhibitors

Ketoconazole

Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of

zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4

inhibitor and zolpidem are given together [see Clinical Pharmacology ( 12.3)] .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to

experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data].

Published data on the use of zolpidem during pregnancy have not reported a clear association with

zolpidem and major birth defects [see Data]. Oral administration of zolpidem to pregnant rats and rabbits

did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated populations are

unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In

the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/neonatal adverse reactions

Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates.

Monitor neonates exposed to zolpidem during pregnancy and labor for signs of excess sedation,

hypotonia, and respiratory depression and manage accordingly.

Data

Human data

Published data from observational studies, birth registries, and case reports on the use of zolpidem

during pregnancy do not report a clear association with zolpidem and major birth defects.

There are limited postmarketing reports of severe to moderate cases of respiratory depression that

occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases

required artificial ventilation or intratracheal intubation. The majority of neonates recovered within

hours to a few weeks after birth once treated.

Zolpidem has been shown to cross the placenta.

Animal data

Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100

mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended human dose

(MRHD) of 10 mg/day (8 mg zolpidem base) based on mg/m2 body surface area, caused delayed fetal

development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times

the MRHD based on mg/m2 body surface area.

Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16

mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem

base) based on mg/m2 body surface area caused embryo-fetal death and delayed fetal development

(incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times

the MRHD based on mg/m2 body surface area.

Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and

100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg

zolpidem base) based on mg/m2 body surface area, delayed offspring growth and decreased survival at

doses 25 and 120 times, respectively, the MRHD based on mg/m2 body surface area.

8.2 Lactation

Risk Summary

Limited data from published literature report the presence of zolpidem in human milk. There are reports

of excess sedation in infants exposed to zolpidem through breastmilk [see Clinical Considerations].

There is no information on the effects of zolpidem on milk production. The developmental and health

benefits of breastfeeding should be considered along with the mother's clinical need for zolpidem and

any potential adverse effects on the breastfed infant from zolpidem or from the underlying maternal

condition.

Clinical Considerations

Infants exposed to zolpidem through breastmilk should be monitored for excess sedation, hypotonia, and

respiratory depression. A lactating woman may consider interrupting breastfeeding and pumping and

discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after

zolpidem administration in order to minimize drug exposure to a breast fed infant.

8.4 Pediatric Use

Zolpidem is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric

patients below the age of 18 years have not been established.

In an 8-week study, in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-

deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at

bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders

comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem

versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations

were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who

received placebo reported hallucinations [see Warnings and Precautions ( 5.4)] . Ten patients on

zolpidem (7.4%) discontinued treatment due to an adverse reaction.

8.5 Geriatric Use

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who

received zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem at doses of

≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for

zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they

could be considered drug related).

Adverse Event

Zolpidem

Placebo

Dizziness

Drowsiness

Diarrhea

A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%)

who were ≥70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A

total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24

(75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10

The dose of zolpidem tartrate tablets in elderly patients is 5 mg to minimize adverse effects related to

impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see

Warnings and Precautions ( 5.1) ].

8.6 Gender Difference in Pharmacokinetics

Women clear zolpidem tartrate from the body at a lower rate than men. C

and AUC parameters of

zolpidem were approximately 45% higher at the same dose in female subjects compared with male

subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose,

the recommended initial dose of zolpidem for adult women is 5 mg, and the recommended dose for adult

men is 5 or 10 mg.

In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of

zolpidem in geriatric patients is 5 mg regardless of gender.

8.7 Hepatic Impairment

The recommended dose of zolpidem tartrate tablets in patients with mild to moderate hepatic impairment

is 5 mg once daily immediately before bedtime. Avoid zolpidem tartrate tablets use in patients with

severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration ( 2.2),

Warnings and Precautions ( 5.7), Clinical Pharmacology ( 12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

9.2 Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is

characterized by misuse of the drug for non-medical purposes, often in combination with other

psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces

changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to

both desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental

factors influencing its development and manifestations. Its characterized by behaviors that include one

or more of the following: impaired control over drug use, compulsive use, continued use despite harm,

and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is

common.

Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem

tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was

difficult to distinguish from placebo.

Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for

misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem

or any other hypnotic.

9.3 Dependence

Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that

can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or

administration of an antagonist.

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation.

These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may

include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following

adverse events, which are considered to meet the DSM-III-R criteria for uncomplicated

sedative/hypnotic withdrawal, were reported during U.S. clinical trials following placebo substitution

occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness,

uncontrolled crying, emesis, stomach cramps, panic attack, nervousness and abdominal discomfort.

These reported adverse events occurred at an incidence of 1% or less. However, available data cannot

provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended

doses. Postmarketing reports of abuse, dependence and withdrawal have been received.

10 OVERDOSAGE

10.1 Signs and Symptoms

In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-

depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular

and/or respiratory compromise, and fatal outcomes have been reported.

10.2 Recommended Treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage

where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic

effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil

administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases

of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored

and general supportive measures employed. Hypotension and CNS depression should be monitored and

treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem

overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not

been determined, although hemodialysis studies in patients with renal failure receiving therapeutic

doses have demonstrated that zolpidem is not dialyzable.

As with the management of all overdosage, the possibility of multiple drug ingestion should be

considered. The physician may wish to consider contacting a poison control center for up-to-date

information on the management of hypnotic drug product overdosage.

11 DESCRIPTION

Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the

imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral

administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate

(2:1). It has the following structure:

Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water,

alcohol, and propylene glycol. It has a molecular weight of 764.88.

Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose

monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch

glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the

short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing

GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of

neuronal excitation.

12.2 Pharmacodynanamics

Zolpidem binds to GABA A receptors with greater affinity for α1subunit relative to α2 and α3 subunit

containing receptors. Zolpidem has no appreciable binding affinity for α5 subunit containing GABA A

receptors. This binding profile may explain the relative absence of myorelaxant effects in animal

studies. Zolpidem has no appreciable binding affinity for dopaminergic D2, serotonergic 5HT2,

adrenergic, histaminergic or muscarinic receptors.

12.3 Pharmacokinetics

The pharmacokinetic profile of zolpidem tartrate tablets is characterized by rapid absorption from the

gastrointestinal tract and a short elimination half-life (T

) in healthy subjects.

In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg zolpidem tartrate

tablets, the mean peak concentrations (C

) were 59 (range: 29 to 113) and 121 (range: 58 to 272)

ng/mL, respectively, occurring at a mean time (T

) of 1.6 hours for both. The mean zolpidem tartrate

tablets elimination half-life was 2.6 (range: 1.4 to 4.5) and 2.5 (range: 1.4 to 3.8) hours, for the 5 and 10

mg tablets, respectively. Zolpidem tartrate tablets are converted to inactive metabolites that are

eliminated primarily by renal excretion. Zolpidem tartrate tablets demonstrated linear kinetics in the dose

range of 5 to 20 mg. Total protein binding was found to be 92.5 ± 0.1% and remained constant,

independent of concentration between 40 and 790 ng/mL. Zolpidem did not accumulate in young adults

following nightly dosing with 20 mg zolpidem tartrate tablets for 2 weeks.

A food-effect study in 30 healthy male subjects compared the pharmacokinetics of zolpidem tartrate

tablets 10 mg when administered while fasting or 20 minutes after a meal. Results demonstrated that with

food, mean AUC and C

were decreased by 15% and 25%, respectively, while mean T

prolonged by 60% (from 1.4 to 2.2 hr). The half-life remained unchanged. These results suggest that,

for faster sleep onset, zolpidem tartrate tablets should not be administered with or immediately after a

meal.

Special Populations

Elderly

In the elderly, the dose for zolpidem tartrate tablets should be 5 mg [see Warnings and Precautions ( 5),

Dosage and Administration ( 2)]. This recommendation is based on several studies in which the mean C

, and AUC were significantly increased when compared to results in young adults. In one

study of eight elderly subjects (>70 years), the means for C

, and AUC significantly increased

by 50% (255 vs. 384 ng/mL), 32% (2.2 vs. 2.9 hr), and 64% (955 vs. 1,562 ng·hr/mL), respectively, as

compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Zolpidem tartrate

tablets did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week.

Hepatic impairment

The pharmacokinetics of zolpidem tartrate tablets in eight patients with chronic hepatic insufficiency

was compared to results in healthy subjects. Following a single 20 mg oral zolpidem tartrate dose, mean

and AUC were found to be two times (250 vs. 499 ng/mL) and five times (788 vs. 4,203 ng·hr/mL)

higher, respectively, in hepatically compromised patients. T

did not change. The mean half-life in

cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normal subjects of

2.2 hr (range: 1.6 to 2.4 hr) [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.7), Use in

Specific Populations ( 8.7)].

Renal impairment

The pharmacokinetics of zolpidem tartrate was studied in 11 patients with end-stage renal failure (mean

= 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem

tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed

for C

, half-life, and AUC between the first and last day of drug administration when baseline

concentration adjustments were made. Zolpidem was not hemodialyzable. No accumulation of unchanged

drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally

impaired patients. No dosage adjustment is necessary in patients with compromised renal function.

Drug Interactions

CNS-depressants

Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression [see

Warnings and Precautions ( 5.1)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose

interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no

pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an

additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem

produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and

psychomotor performance.

A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics

or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration

does not predict the absence of an effect following chronic administration.

An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was

demonstrated [see Warnings and Precautions ( 5.1)].

Following five consecutive nightly doses at bedtime of oral zolpidem tartrate 10 mg in the presence of

sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem C

was significantly higher (43%) and T

was significantly decreased (-53%). Pharmacokinetics of

sertraline and N-desmethylsertraline were unaffected by zolpidem.

A single-dose interaction study with zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels

in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic

interactions. When multiple doses of zolpidem and fluoxetine were given at steady state and the

concentrations evaluated in healthy females, an increase in the zolpidem half-life (17%) was observed.

There was no evidence of an additive effect in psychomotor performance.

Drugs that affect drug metabolism via cytochrome P450

Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors

of other P450 enzymes on the pharmacokinetics of zolpidem is unknown.

A single-dose interaction study with zolpidem tartrate 10 mg and itraconazole 200 mg at steady-state

levels in male volunteers resulted in a 34% increase in AUC

of zolpidem tartrate. There were no

pharmacodynamic effects of zolpidem detected on subjective drowsiness, postural sway, or

psychomotor performance.

0-∞

A single-dose interaction study with zolpidem tartrate 10 mg and rifampin 600 mg at steady-state levels

in female subjects showed significant reductions of the AUC (-73%), C

(-58%), and T

(-36 %)

of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate.

Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of

zolpidem [see Drug Interactions ( 7.2)].

Similarly, St. John's wort, a CYP3A4 inducer, may also decrease the blood levels of zolpidem.

A single-dose interaction study with zolpidem tartrate 5 mg and ketoconazole, a potent CYP3A4

inhibitor, given as 200 mg twice daily for 2 days increased C

of zolpidem (30%) and the total AUC

of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30 %) along

with an increase in the pharmacodynamic effects of zolpidem [see Drug Interactions ( 7.2)].

Additionally, fluvoxamine (a strong inhibitor of CYP1A2 and a weak inhibitor of CYP3A4 and CYP2C9)

and ciprofloxacin (a strong inhibitor of CYP1A2 and a moderate inhibitor of CYP3A4) are also likely to

inhibit zolpidem's metabolic pathways, potentially leading to an increase in zolpidem exposure.

Other drugs with no interactions with zolpidem

A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no

effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.

Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when

given with warfarin in healthy subjects.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Zolpidem was administered to mice and rats for 2 years at oral doses of 4, 18, and 80 mg base/kg/day. In

mice, these doses are approximately 2.5, 10, and 50 times the MRHD of 10 mg/day (8 mg zolpidem

base) based on mg/m

body surface area and in rats, these doses are approximately 5, 20, and 100 times

the MRHD based on a mg/m

body surface area. No evidence of carcinogenic potential was observed

in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid and high doses.

Mutagenesis

Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal

aberration) and in vivo (mouse micronucleus) genetic toxicology assays.

Impairment of fertility

Zolpidem was administered to rats at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and

120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m

body surface area, prior to

and during mating, and continuing in females through postpartum day 25. Zolpidem caused irregular

estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 120

times the MRHD based on mg/m

body surface area. The NOAEL for these effects is 25 times the

MRHD based on a mg/m

body surface area. There was no impairment of fertility at any dose tested.

14 CLINICAL STUDIES

14.1 Transient Insomnia

Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were

evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and

10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic)

measures of sleep latency, sleep duration, and number of awakenings.

Normal elderly adults (mean age 68) experiencing transient insomnia (n=35) during the first two nights

in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of

zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two

primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep

duration, sleep latency, number of awakenings, and sleep quality).

14.2 Chronic Insomnia

Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia

(most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of

Mental Disorders, DSM-IV™). Adult outpatients with chronic insomnia (n=75) were evaluated in a

double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate and placebo. On

objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was

superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4.

Zolpidem was comparable to placebo on number of awakenings at both doses studied.

Adult outpatients (n=141) with chronic insomnia were also evaluated, in a double-blind, parallel group,

4-week trial comparing two doses of zolpidem and placebo. Zolpidem 10 mg was superior to placebo

on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time,

number of awakenings, and sleep quality for the first treatment week.

Increased wakefulness during the last third of the night as measured by polysomnography has not been

observed in clinical trials with zolpidem tartrate tablets.

14.3 Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs

Next-Day Residual Effects

Next-day residual effects of zolpidem tartrate tablets were evaluated in seven studies involving normal

subjects. In three studies in adults (including one study in a phase advance model of transient insomnia)

and in one study in elderly subjects, a small but statistically significant decrease in performance was

observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of zolpidem

tartrate tablets in non-elderly patients with insomnia did not detect evidence of next-day residual effects

using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.

Rebound Effects

There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen

in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate tablets. There

was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above

the recommended elderly dose of 5 mg.

Memory Impairment

Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of

next-day memory impairment following the administration of zolpidem tartrate tablets. However, in one

study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning

recall of information presented to subjects during peak drug effect (90 minutes post dose), i.e., these

subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data

for anterograde amnesia occurring in association with the administration of zolpidem tartrate tablets,

predominantly at doses above 10 mg.

Effects on Sleep Stages

In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate tablets

have generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was

found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the

recommended dose.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 63629-8163

NDC: 63629-8163-1 30 TABLET in a BOTTLE

Product: 63629-8200

NDC: 63629-8200-1 30 TABLET in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patients to read the FDA-approved patient labeling (Medication Guide).

Inform patients and their families about the benefits and risks of treatment with zolpidem. Inform patients

of the availability of a Medication Guide and instruct them to read the Medication Guide prior to

initiating treatment with zolpidem and with each prescription refill. Review the zolpidem tartrate tablets

Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that

zolpidem tartrate tablets should be taken only as prescribed.

CNS-Depressant Effects and Next-Day Impairment

Tell patients that zolpidem has the potential to cause next-day impairment, and that this risk is increased

if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing

before driving or engaging in other activities requiring full mental alertness. Inform patients that

impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and

decreased consciousness may increase the risk of falls in some patients.

Severe Anaphylactic and Anaphylactoid Reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem.

Describe the signs/symptoms of these reactions and advise patients to seek medical attention

immediately if any of them occur.

Sleep-driving and Other Complex Behaviors

Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior

change, including "sleep driving" and other complex behaviors while not being fully awake (preparing

and eating food, making phone calls, or having sex). Tell patients to call you immediately if they

develop any of these symptoms.

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol and Other Drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without

a prescription. Advise patients not to use zolpidem if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of zolpidem on their own, and to inform you if they believe the

drug "does not work".

Administration Instructions

Patients should be counseled to take zolpidem right before they get into bed and only when they are able

to stay in bed a full night (7 to 8 hours) before being active again. Zolpidem tartrate tablets should not be

taken with or immediately after a meal. Advise patients NOT to take zolpidem if they drank alcohol that

evening.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant

during treatment with zolpidem tartrate tablets. Advise patients that use of zolpidem tartrate tablets late in

the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used

zolpidem tartrate tablets during the late third trimester of pregnancy to monitor neonates for signs of

sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations ( 8.1)].

Lactation

Advise breastfeeding mothers using zolpidem tartrate tablets to monitor infants for increased

sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical

care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk

during treatment and for 23 hours after zolpidem tartrate tablets administration to minimize drug

exposure to a breastfed infant [see Use in Specific Populations ( 8.2)] .

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8075160 Revised April 2019

MEDICATION GUIDE

Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV

Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each

time you get a refill. There may be new information. This Medication Guide does not take the place of

talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about zolpidem tartrate tablets?

Do not take more zolpidem tartrate tablets than prescribed.

Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7 to 8

hours) before you must be active again.

Take zolpidem tartrate tablets right before you get in bed, not sooner.

Zolpidem tartrate tablets may cause serious side effects, including:

After taking zolpidem tartrate tablets, you may get up out of bed while not being fully awake

and do an activity that you do not know you are doing. The next morning, you may not

remember that you did anything during the night. You have a higher chance for doing these

activities if you drink alcohol or take other medicines that make you sleepy with zolpidem tartrate

tablets. Reported activities include:

o driving a car ("sleep-driving")

o making and eating food

o talking on the phone

o having sex

o sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above

activities after taking zolpidem tartrate tablets.

Do not take zolpidem tartrate tablets if you:

drank alcohol that evening or before bed

took another medicine to help you sleep

What are zolpidem tartrate tablets?

Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in

adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years.

Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused or

lead to dependence. Keep zolpidem tartrate tablets in a safe place to prevent misuse and

abuse. Selling or giving away zolpidem tartrate tablets may harm others, and is against

the law. Tell your healthcare provider if you have ever abused or have been dependent

on alcohol, prescription medicines or street drugs.

Who should not take zolpidem tartrate tablets?

Do not take zolpidem tartrate tablets if you are allergic to zolpidem or any other ingredients in

zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in

zolpidem tartrate tablets.

Do not take zolpidem tartrate tablets if you have had an allergic reaction to drugs containing

zolpidem, such as zolpidem tartrate CR tablets, Edluar, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include:

swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking zolpidem tartrate tablets?

Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell

your healthcare provider about all of your health conditions, including if you:

have a history of depression, mental illness, or suicidal thoughts

have a history of drug or alcohol abuse or addiction

have kidney or liver disease

have a lung disease or breathing problems

are pregnant, planning to become pregnant. Talk to your healthcare provider about the risk to your

unborn baby if you take zolpidem tartrate tablets.

Using zolpidem tartrate tablets in the last trimester of pregnancy may cause breathing difficulties or

excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual),

troublebreathing, or limpness in the newborn if zolpidem tartrate tablets is taken late in pregnancy.

are breastfeeding or plan to breastfeed.

Zolpidem tartrate tablets passes into your breast milk. Talk to your healthcare provider about the

best way to feed your baby while you take zolpidem tartrate tablets.

Zolpidem tartrate tablets can pass into your breast milk. It is not known if zolpidem tartrate tablets will

harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take

zolpidem tartrate tablets.

Tell your healthcare provider about all of the medicines you take, including prescription and

nonprescription medicines, vitamins and herbal supplements.

Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem

tartrate tablets with other medicines that can make you sleepy unless your healthcare provider

tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider

and pharmacist each time you get a new medicine.

How should I take zolpidem tartrate tablets?

See "What is the most important information I should know about zolpidem tartrate

tablets ?"

Take zolpidem tartrate tablets exactly as prescribed. Only take 1 zolpidem tartrate tablet a night if

needed.

Do not take zolpidem tartrate tablets if you drank alcohol that evening or before bed.

You should not take zolpidem tartrate tablets with or right after a meal. Zolpidem tartrate tablets

may help you fall asleep faster if you take it on an empty stomach.

Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This

may mean that there is another condition causing your sleep problem.

If you take too much zolpidem tartrate tablets or overdose, get emergency treatment.

What are the possible side effects of zolpidem tartrate tablets?

Zolpidem tartrate tablets may cause serious side effects, including:

getting out of bed while not being fully awake and do an activity that you do not know you are

doing. See " What is the most important information I should know about zolpidem tartrate

tablets? "

abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than

normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or

actions.

memory loss

anxiety

severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble

breathing. Get emergency medical help if you get these symptoms after taking zolpidem tartrate

tablets.

falls, which may lead to severe injuries

Call your healthcare provider right away if you have any of the above side effects or any other

side effects that worry you while using zolpidem tartrate tablets.

The most common side effects of zolpidem tartrate tablets are:

drowsiness

dizziness

diarrhea

grogginess or feeling as if you have been drugged

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

trouble sleeping

nausea

flushing

lightheadedness

uncontrolled crying

vomiting

stomach cramps

panic attack

nervousness

stomach area pain

These are not all the side effects of zolpidem tartrate tablets. Ask your healthcare provider or

pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–

FDA–1088.

How should I store zolpidem tartrate tablets?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP

Controlled Room Temperature].

Keep zolpidem tartrate tablets and all medicines out of reach of children.

General Information about the safe and effective use of zolpidem tartrate tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use zolpidem tartrate tablets for a condition for which it was not prescribed. Do not share zolpidem

tartrate tablets with other people, even if they have the same symptoms that you have. It may harm them

and it is against the law.

This Medication Guide summarizes the most important information about zolpidem tartrate tablets. If you

would like more information, talk with your healthcare provider. You can ask your healthcare provider

or pharmacist for information about zolpidem tartrate tablets that are written for healthcare

professionals.

For more information, call 1-800-912-9561.

What are the ingredients in zolpidem tartrate tablets?

Active Ingredient: Zolpidem tartrate, USP

Inactive Ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium

stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg

tablet also contains ferric oxide yellow.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8075161 Revised April 2019

ZOLPIDEM TARTRATE 5MG (CIV) TABLET

ZOLPIDEM TARTRATE 10MG (CIV) TABLET

ZOLPIDEM TARTRATE

zolpidem tartrate tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -

8 16 3(NDC:136 6 8 -0 0 7)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZO LPIDEM TARTRATE (UNII: WY6 W6 38 43K) (ZOLPIDEM - UNII:7K38 3OQI23)

ZOLPIDEM TARTRATE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Product Characteristics

Color

red (Red)

S core

no sco re

S hap e

CAPSULE (Capsule)

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 16 3-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 3/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 779 0 3

0 9 /0 5/20 0 7

ZOLPIDEM TARTRATE

zolpidem tartrate tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -

8 20 0 (NDC:136 6 8 -0 0 8 )

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZO LPIDEM TARTRATE (UNII: WY6 W6 38 43K) (ZOLPIDEM - UNII:7K38 3OQI23)

ZOLPIDEM TARTRATE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Product Characteristics

Color

yello w (peach-yello w)

S core

no sco re

S hap e

CAPSULE (Capsule)

S iz e

10 mm

Flavor

Imprint Code

10 MG

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

Bryant Ranch Prepack

1

NDC:6 36 29 -8 20 0 -1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 779 0 3

0 9 /0 5/20 0 7

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 20 0 , 6 36 29 -8 16 3) , RELABEL(6 36 29 -8 16 3, 6 36 29 -8 20 0 )

Revised: 8/2019

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