Quazepam
Quazepam is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Quazepam. Available dosage forms: powder, tablet.
Drug Details
- Generic Name
- Quazepam
- Brand Names
- Quazepam
- Application Number
- NDA018708
- Sponsor
- TATEYAMA KASEI CO.,LTD.
- NDC Codes
- 2
- Dosage Forms
- POWDER, TABLET
- Routes
- ORAL
- Active Ingredients
- QUAZEPAM
Indications and Usage
1 INDICATIONS AND USAGE Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. Quazepam Tablets, a gamma-aminobutyric (GABAA) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. ( 1 )