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Zaleplon

ATC code N05CF03

Key facts
Active substance
Zaleplon
Drug class
Hypnotics and sedatives
ATC code
N05CF03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zaleplon . Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS).

Key facts

Zaleplon is a hypnotic. Per the US prescribing information, its capsules are used for the short-term treatment of insomnia.

What it is used for

  • Short-term treatment of insomnia; shown to decrease time to sleep onset for up to 30 days in studies
  • Not shown to increase total sleep time or decrease the number of awakenings

Dosing

  • Usually 10 mg for nonelderly adults; 5 mg may suffice for low weight individuals; 20 mg only for the occasional patient; doses above 20 mg not recommended
  • Take immediately before bedtime or after going to bed with difficulty falling asleep; not with or immediately after a heavy, high-fat meal
  • Elderly or debilitated patients: 5 mg, not more than 10 mg
  • Mild to moderate hepatic impairment: 5 mg; severe hepatic impairment: not recommended; with cimetidine: initial dose 5 mg

Contraindications

  • Complex sleep behaviors after previous zaleplon use
  • Hypersensitivity to zaleplon or any excipient

Important warnings

  • Boxed warning: complex sleep behaviors (sleep-walking, sleep-driving and others) with serious injuries, including death; discontinue immediately
  • CNS-depressant effects and next-day impairment; increased risk with other CNS depressants (benzodiazepines, opioids, tricyclic antidepressants, alcohol)
  • Rare angioedema and anaphylaxis; do not rechallenge after angioedema
  • Behavioral changes, amnesia, hallucinations; withdrawal symptoms after abrupt discontinuation
  • If insomnia persists after 7 to 10 days, evaluate for co-morbid conditions

Side effects

  • With 5 mg or 10 mg: headache 30%, dizziness 7%, nausea 6%, abdominal pain 6%, asthenia 5%, somnolence 5%
  • More frequent at 20 mg: e.g. amnesia, paresthesia, eye pain, dysmenorrhea

Interactions

  • Other CNS depressants and alcohol: additive effects; not with other sedative-hypnotics at bedtime
  • Rifampin: zaleplon exposure reduced by approximately 80%
  • Cimetidine: reduced clearance, initial dose 5 mg

Pregnancy and breastfeeding

  • No adequate studies in pregnant women; not recommended during pregnancy
  • A small amount is excreted in breast milk; effects on the nursing infant are unknown

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Brand names in 1 more European countries
Poland
Morfeo

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. ZALEPLON (Rising Pharma Holdings, Inc.) – Prescribing Information, 2024-05-08. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cff46def-c452-49bb-abea-480de8f432bd
  2. Wikidata (CC0): ATC N05CF.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.