FDA label
What is zaleplon used for?
The FDA-approved uses of zaleplon, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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 ...”
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Zaleplon, capsule
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA078829). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id cff46def-c452-49bb-abea-480de8f432bd, version 6, effective May 8, 2024. NDC 57237-239, one of 20 listings for this product.
Questions
What is zaleplon used for?
The FDA label says: “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 ...”
What drug class is zaleplon?
FDA lists zaleplon in the gamma-Aminobutyric Acid A Receptor Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.