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:

Aphena Pharma Solutions - Tennessee, LLC

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 6.25 mg tablets are composed of two layers1 and are coated, pink, round, biconvex, debossed with ZCR on one side and supplied as: Zolpidem Tartrate Extended-Release 12.5 mg tablets are composed of two layers1 and are coated, blue, round, biconvex, debossed with ZCR on one side and supplied as: Store between 15°C–25°C (59°F–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
Aphena Pharma Solutions - Tennessee, LLC
----------
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 including complex
sleep behaviors that have caused serious injury and death. After
taking ZOLPIDEM TARTRATE
Extended-Release 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 (complex sleep behaviors). The next
morning, you may not remember that
you did anything during the night. These activities may occur with
ZOLPIDEM TARTRATE Extended-
Release Tablets whether or not you drink alcohol or take other
medicines that make you sleepy. Reported
activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking ZOLPIDEM TARTRATE Extended-Release Tablets and 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-

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration (2)
4/2013
Dosage and Administration, Dosage in Adults (2.1)
4/2013
Warnings and Precautions (5)
4/2013
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
Use the lowest dose effective for the patient (2.1)
Recommended initial dose is 6.25 mg for women, and 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 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 6.25 mg and 12.5 mg extended-release tablets. Tablets not
scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impaired alertness and motor coordination,
including risk of morning impairment. Caution
patients against driving and other activities requiring complete
mental alertness the morning after use. (5.1)
Need to evaluate for co-morbid diagnoses: Revaluate if insomnia
persists after 7 to 10 days of use (5.2)
Se