ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Available from:

REMEDYREPACK INC.

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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 4-5 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)] . 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

Product summary:

Zolpidem Tartrate Tablets, USP are available containing 5 mg or 10 mg of zolpidem tartrate, USP. The 5 mg tablets are lavender, film-coated, round, unscored tablets debossed with M over Z1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5305-01 bottles of 100 tablets NDC 0378-5305-05 bottles of 500 tablets The 10 mg tablets are lavender, film-coated, round, unscored tablets debossed with M over Z2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5310-01 bottles of 100 tablets NDC 0378-5310-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
REMEDYREPACK INC.
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MEDICATION GUIDE
Zolpidem Tartrate Tablets, USP CIV
(zole pi' dem tar' trate)
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:
•
driving a car (“sleep-driving”)
•
making and eating food
•
talking on the phone
•
having sex
•
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 a 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 i

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
REMEDYREPACK INC.
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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 TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A receptor
positive modulator, are 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 7-8 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 diagnosis: Reevaluate 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