ZOLPIDEM TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp.

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 5 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 tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Oral studies of zolpidem in pregnant rats and rabbits showed adverse effects on the development of o

Product summary:

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 and supplied as: NDC Number                                                                               Size 21695-506-07                                                                              bottle of 7 21695-506-15                                                                              bottle of 15 21695-506-30                                                                              bottle of 30 21695-506-60                                                                              bottle of 60 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 and supplied as: NDC Number                                                                               Size 21695-507-07                                                                             bottle of 7 21695-507-10                                                                              bottle of 10 21695-507-15                                                                              bottle of 15 21695-507-30                                                                              bottle of 30 21695-507-60                                                                              bottle of 60 Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET
Rebel Distributors Corp.
----------
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 doctor about your medical condition or treatment.
What is the most important information I should know about zolpidem
tartrate tablets?
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 doctor right away if you find out that you have done any of
the above activities after taking
zolpidem tartrate tablets.
Important:
1. Take zolpidem tartrate tablets exactly as prescribed
•
Do not take more zolpidem tartrate tablets than prescribed.
•
Take zolpidem tartrate tablets right before you get in bed, not
sooner.
2. Do not take zolpidem tartrate tablets if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines.
Your doctor will tell you if you can take zolpidem tartrate tablets
with your other medicines.
•
cannot get a full night’s 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. Symptoms of insomnia include:
•
trouble falling asleep
Zolpidem tartrate tablets are not for children.
Zolpidem tartrate is a federally controlled substance (C-
IV) because it can be abused or lead to dependence.
Keep zolpidem

Summary of Product characteristics

ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET
REBEL DISTRIBUTORS CORP.
----------
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 TABLET FOR ORAL USE - CIV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage (1) 03/2007
WARNINGS AND PRECAUTIONS
Severe anaphylactic and anaphylactoid reactions (5.2) 03/2007
Abnormal thinking and behavioral changes (5.3) 03/2007
Special populations (5.6) 03/2007
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 10 mg once daily immediately before bedtime (2.1)
Elderly/debilitated patients/hepatically impaired: 5 mg once daily
immediately before bedtime (2.2)
Downward dosage adjustment may be necessary when used with CNS
depressants (2.3)
Should not be 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 tartrate or to any of the inactive
ingredients in the formulation (4.1)
WARNINGS AND PRECAUTIONS
Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia
persists after 7 to 10 days of use (5.1)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not rechallenge if
such reactions occur. (5.2)
Abnormal thinking, behavioral changes and complex behaviors: May
include "sleep-driving" and hallucinations.
Immediately evaluate any new onset behavioral changes. (5.3)
Depression: Worsening of depression or, suicidal thinking may occur.
Prescribe the least amount feasible to avoid
intentional overdose (5.3,5.6)
Withdrawal effects: Symptoms may occur with rapid dos