Treats insomnia. ANDA 78829, held by Aurobindo Pharma. Zaleplon.
As of Nov 14, 2026, ANDA 78829 (Zaleplon), held by Aurobindo Pharma, was first approved by FDA on Jun 6, 2008, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). They have not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2008 | Original application | Approved |
| Oct 17, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 17, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 11, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 6, 2008 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
