zolpidem tartrate
Drug Details
- Generic Name
- zolpidem tartrate
- Brand Names
- ZOLPIDEM TARTRATE, Ambien, zolpidem tartrate, Ambien CR, Zolpidem Tartrate
- Application Number
- ANDA077903
- Sponsor
- Proficient Rx LP
- NDC Codes
- 47
- 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 Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )