Quazepam

FDA Drug Profile — Quazepam

Drug Details

Generic Name
Quazepam
Brand Names
Quazepam
Application Number
NDA018708
Sponsor
Atland Pharmaceuticals, LLC
NDC Codes
2
Dosage Forms
TABLET, POWDER
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 )