zolpidem tartrate
zolpidem tartrate is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including ZOLPIDEM TARTRATE, Zolpidem Tartrate, zolpidem tartrate. Available dosage forms: tablet, tablet, film coated, extended release, tablet, film coated, capsule, tablet, coated.
Drug Details
- Generic Name
- zolpidem tartrate
- Brand Names
- ZOLPIDEM TARTRATE, Zolpidem Tartrate, zolpidem tartrate, Ambien CR, Ambien
- Application Number
- ANDA077903
- Sponsor
- Asclemed USA, Inc.
- NDC Codes
- 50
- Dosage Forms
- TABLET, TABLET, FILM COATED, EXTENDED RELEASE, TABLET, FILM COATED, CAPSULE, TABLET, COATED
- 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 )