Zolpidem tartrate sublingual
Drug Details
- Generic Name
- Zolpidem tartrate sublingual
- Brand Names
- Zolpidem tartrate sublingual
- Application Number
- ANDA204229
- Sponsor
- ENDO USA, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET
- Routes
- SUBLINGUAL
- Active Ingredients
- ZOLPIDEM TARTRATE
Indications and Usage
1 INDICATIONS AND USAGE Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem tartrate sublingual tablets are a GABA A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep Limitation of Use : Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking