zolpidem tartrate
zolpidem tartrate is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including ZOLPIDEM TARTRATE, Ambien, Ambien CR. Available dosage forms: tablet, tablet, film coated, tablet, coated, tablet, film coated, extended release, capsule.
Drug Details
- Generic Name
- zolpidem tartrate
- Brand Names
- ZOLPIDEM TARTRATE, Ambien, Ambien CR, Zolpidem Tartrate, zolpidem tartrate
- Application Number
- ANDA077903
- Sponsor
- Asclemed USA, Inc.
- NDC Codes
- 50
- Dosage Forms
- TABLET, TABLET, FILM COATED, TABLET, COATED, TABLET, FILM COATED, EXTENDED RELEASE, CAPSULE
- Routes
- ORAL, SUBLINGUAL
- Active Ingredients
- ZOLPIDEM TARTRATE
Indications and Usage
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets, USP are indicated for the short-term 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, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )