Zaleplon

What it is and how it works

Mechanism class: GABA A Agonists

Indications

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 latency were performed at the end of treatment.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.

Contraindications

CONTRAINDICATIONS Zaleplon is contraindicated in patients: who have experienced complex sleep behaviors after taking zaleplon (see WARNINGS ) with hypersensitivity to zaleplon or any excipients in the formulation (see PRECAUTIONS )

Warnings and precautions

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 eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events.

Storage and supply

STORAGE CONDITIONS Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) . Dispense in a light-resistant container as defined in the USP. Additional Medication Guide's can be obtained by calling Unichem at 1-866- 562-4616. 06-R-10/2020

Source: Zaleplon (Zaleplon) — US FDA prescribing information, 2025-10-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.