ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ZOLPIDEM TARTRATE

Sammensætning:

ZOLPIDEM TARTRATE 6.25 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 tartrate. 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 us

Produkt oversigt:

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: 35356-845-30  Bottles of 30 NDC: 35356-845-60  Bottles of 60 NDC: 35356-845-90  Bottles of 90 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: Each tablet contains 12.5 mg of zolpidem tartrate, USP. *Portions are covered by the coating and are indistinguishable. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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 SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE.
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED
RELEASE FOR ORAL USE.
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, 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 extend-release
tablets (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of zolpidem tartrate extend-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