MedeliX
Start asking

Eszopiclone

Esogno · ATC code N05CF04

Also known as: Eszopiclon, Eszopiklon

Key facts
Active substance
Eszopiclone
Drug class
Hypnotics and sedatives
ATC code
N05CF04
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 eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)].

Key facts

Eszopiclone is a sedative-hypnotic. Per the US prescribing information, it is used to treat insomnia, decreasing sleep latency and improving sleep maintenance.

What it is used for

  • Treatment of insomnia (sleep onset and sleep maintenance)
  • Clinical trials lasted up to 6 months

Dosing

  • Use the lowest effective dose; take immediately before bedtime
  • Adults: starting dose 1 mg, may be raised to 2 mg or 3 mg if clinically indicated; total dose not to exceed 3 mg once daily
  • Elderly or debilitated patients: not to exceed 2 mg
  • Severe hepatic impairment or potent CYP3A4 inhibitors: not to exceed 2 mg
  • With other CNS depressants, dose adjustment may be needed
  • Taking it with or right after a heavy, high-fat meal slows absorption and may reduce the effect on sleep latency

Contraindications

  • Complex sleep behaviors after previous use of eszopiclone
  • Known hypersensitivity to eszopiclone (including anaphylaxis, angioedema)

Important warnings

  • Boxed warning: complex sleep behaviors such as sleep-walking and sleep-driving, sometimes with serious injury including death; discontinue immediately if they occur
  • CNS depressant effects and next-day impairment, particularly at 2 mg or 3 mg; after 3 mg avoid driving or hazardous activities the next day
  • Evaluate for underlying physical or psychiatric disorders; failure to remit after 7 to 10 days warrants re-evaluation
  • Severe anaphylactic reactions and angioedema
  • Abnormal thinking and behavioral changes, amnesia; withdrawal symptoms after abrupt discontinuation

Side effects

  • Unpleasant taste (clearly dose-related)
  • Headache, dizziness, dry mouth, infection, rash, hallucinations
  • Complex sleep behaviors, next-day impairment

Interactions

  • Alcohol and other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants): additive effects
  • Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir): increased exposure, dose reduction needed
  • CYP3A4 inducers such as rifampicin: decreased exposure and effect
  • Olanzapine: pharmacodynamic interaction

Pregnancy and breastfeeding

  • Data in pregnant women are insufficient to identify a drug-associated risk

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.

Full official text →

Common questions – ask Medelix

For patients

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.

Austria

  • EsognoG.L. Pharma Gmbh · 1 register entry

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

Germany

  • EsognoG.L. Pharma Gmbh · 1 register entry
  • LuniviaHennig Arzneimittel Gmbh & Co. Kg · 1 register entry

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

USA

  • LunestaWaylis Therapeutics LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 10 more European countries
Bulgaria
Есогно
Czechia
Esogno
Estonia
Esogno
France
Noxiben
Hungary
Esogno
Italy
Esnoxiben
Latvia
Esogno
Lithuania
Esogno
Poland
Esogno
Slovakia
Esogno

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.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Eszopiclone (Glenmark Pharmaceuticals Inc. USA) – Prescribing Information, 2026-01-30. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=584dc66c-063a-4552-a056-74b811e2bc80
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  5. 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.