ZOLPIDEM TARTRATE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

zolpidem tartrate (UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)

Available from:

Proficient Rx LP

INN (International Name):

zolpidem tartrate

Composition:

zolpidem tartrate 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem Tartrate Extended-Release Tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)] . Zolpidem Tartrate Extended-Release Tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Pregnancy Category C There are no adequate and well-controlled studies of Zolpidem Tartrate Extended-Release Tablets in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at th

Product summary:

Zolpidem Tartrate Extended-Release 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with ZCR on one side and supplied as: 63187-862-15 Bottle of 15 63187-862-30 Bottle of 30 63187-862-60 Bottle of 60 63187-862-90 Bottle of 90 Store between 15°–25° C (59°–77°F). Limited excursions permissible up to 30° C (86°F)

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
Proficient Rx LP
----------
MEDICATION GUIDE
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS C-IV
Read the Medication Guide that comes with ZOLPIDEM TARTRATE
Extended-Release 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 Extended-
Release Tablets?
•
Do not take more ZOLPIDEM TARTRATE Extended-Release Tablets than
prescribed.
•
Do not take ZOLPIDEM TARTRATE Extended-Release 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 Extended-Release Tablets right before you get
in bed, not sooner.
ZOLPIDEM TARTRATE Extended-Release Tablets may cause serious side
effects that you may not
know are happening to you. These side effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
"sleep-walking" or doing other activities when you are asleep like:
•
eating
•
talking
•
having sex
•
driving a car
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking ZOLPIDEM TARTRATE Extended-Release Tablets.
You should not drive a car or do things that require clear thinking
the day after you take ZOLPIDEM
TARTRATE Extended-Release Tablets.
Do not take ZOLPIDEM TARTRATE Extended-Release Tablets if you:
•
drank alcohol that evening or before bed
•
take other medicines that can make you sleepy. Taking ZOLPIDEM
TARTRATE Extended-
Release Tablets with other drugs can cause side effects. Talk to your
healthcare provider about all
of your medicines. Your healthcare provider will tell you if you can
take ZOLPIDEM TARTRATE
Extended-Release Tablets with your other medicines.
•
cannot get a full night's sleep
What are

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE EXTENDED-RELEASE
T ABLE TS.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration, Dosage in Adults (2.1)
08/2016
Dosage and Administration, Special Populations (2.2)
12/2016
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment (5.1)
08/2016
Warnings and Precautions, Precipitation of Hepatic Encephalopathy
(5.7)
12/2016
INDICATIONS AND USAGE
Zolpidem Tartrate Extended-Release Tablets, a gamma-aminobutyric acid
(GABA) A agonist, are indicated for the
treatment of insomnia characterized by difficulties with sleep onset
and/or sleep maintenance. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets:12.5 mg extended-release tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
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ADVERSE REACTIONS
Use the lowest dose effective for the patient and must not exceed a
total of 12.5 mg daily (2.1)
Recommended initial dose is a single dose of 6.25 mg for women, and a
single dose of 6.25 or 12.5 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 6.25 mg for men
and women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with Zolpidem Tartrate Extended-
Release Tablets (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed
if taken with or immediately after a meal
(2.4)
CNS depressant effects: