NDC 29300-0131-01

zaleplon 5 mg/1 CAPSULE

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NDC

29300-0131-01

Generic Name

zaleplon

Brand Name

zaleplon

Strength

5 mg/1

Dosage Form

CAPSULE

Route

ORAL

Package Size

—

Labeler

Unichem Pharmaceuticals (USA), Inc.

FDA Drug Information

Indications & Usage

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 ). It has 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 la…

Important Warnings

WARNINGS Complex Sleep Behaviors Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of zaleplon. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. a. Other complex sleep behaviors (e.g., preparing and e…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other zaleplon NDC Codes

29300-0132-0110 mg/1CAPSULE

2-Day

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