ZOLPIDEM TARTRATE- 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:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate extended-release tablets, USP 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)]. Teratogenic Effects: 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 whe

Product summary:

Zolpidem tartrate extended-release tablets, USP 6.25 mg, are composed of two portions* and are coated, white, round, bi-convex, debossed with A2 on one side and supplied as: NDC Number Size Each tablet contains 6.25 mg of zolpidem tartrate, USP. Zolpidem tartrate extended-release tablets, USP 12.5 mg, are composed of two portions* and are coated, yellow, round, bi-convex, debossed with A1 on one side and supplied as: NDC Number Size 55700-495-30 Each tablet contains 12.5 mg of zolpidem tartrate, USP. *Portions are covered by the coating and are indistinguishable. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
ZOLPIDEM (zole-PI-dem) TARTRATE EXTENDED-RELEASE TABLETS, USP C-IV
Rx Only
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

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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 TABLETS.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries (5.8) 10/2014
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets, USP 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 to 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)
Severe anaphylactic/anaphylactoid reactions: Angio