Flurazepam Hydrochloride
Drug Details
- Generic Name
- Flurazepam Hydrochloride
- Brand Names
- Flurazepam Hydrochloride
- Application Number
- ANDA072368
- Sponsor
- Chartwell RX, LLC
- NDC Codes
- 3
- Dosage Forms
- CAPSULE, POWDER
- Routes
- ORAL
- Active Ingredients
- FLURAZEPAM HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies ( 14 ) ]. Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient. Flurazepam, a gamma-aminobutyric (GABA A ) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. ( 1 )