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Zolpidem

Mondeal, Zoldem, Zolpidem G.L., Zolpidem Hexal · ATC code N05CF02

Also known as: Zolpidem Tartrate · Brand names: Mondeal, Zoldem, Zolpidem G.L., Zolpidem Hexal, Zolpidem Ratiopharm, Bikalm, Stilnox, Zolpi-Lich, Zolpinox, Remin, Ambien, Ambien CR, Edluar

Key facts
Active substance
Zolpidem
Drug class
Hypnotics and sedatives
ATC code
N05CF02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate tablets immediately if a patient experiences a complex sleep behaviors [see Contraindications (4) and Warnings and Precautions (5.1)].

Key facts

Zolpidem is a non-benzodiazepine hypnotic. Per the US label it is used for the short-term treatment of insomnia with difficulty falling asleep.

What it is used for

  • Short-term treatment of insomnia characterised by difficulties with sleep initiation

Dosing

  • Lowest effective dose: women 5 mg, men 5 or 10 mg initially, once per night immediately before bedtime
  • Take only with at least 7 to 8 hours remaining before planned awakening; do not exceed 10 mg daily
  • Elderly or debilitated patients and mild to moderate hepatic impairment: 5 mg
  • Severe hepatic impairment: avoid
  • Keep treatment as short as possible; dose adjustment may be needed with other CNS depressants

Contraindications

  • Previous complex sleep behaviours after taking zolpidem
  • Known hypersensitivity (including anaphylaxis, angioedema)

Important warnings

  • Boxed warning: complex sleep behaviours (sleep-walking, sleep-driving) causing serious injuries including death; discontinue immediately
  • CNS-depressant effects and next-day impairment, especially after 10 mg
  • Severe anaphylactic and anaphylactoid reactions
  • Abnormal thinking and behaviour changes; withdrawal effects

Side effects

  • Daytime drowsiness, dizziness, headache
  • Nausea, vomiting
  • Amnesia, falls

Interactions

  • Other CNS depressants and alcohol: increased drowsiness and psychomotor impairment
  • Opioids: increased risk of respiratory depression; limit dose and duration

Pregnancy and breastfeeding

  • Respiratory depression and sedation reported in neonates after use late in the third trimester; no clear association with major birth defects

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

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

  • MondealStada Arzneimittel Gmbh · 1 register entry
  • ZoldemG.L. Pharma Gmbh · 1 register entry
  • Zolpidem G.L.G.L. Pharma Gmbh · 1 register entry
  • Zolpidem HexalHexal Pharma Gmbh · 1 register entry
  • Zolpidem RatiopharmTeva B.V · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • BikalmSanofi-Aventis Deutschland Gmbh · 1 register entry
  • StilnoxSanofi-Aventis Deutschland Gmbh · 1 register entry
  • Zolpi-LichWinthrop Arzneimittel Gmbh · 1 register entry
  • Zolpidem1 A Pharma Gmbh, Ratiopharm Gmbh, Vitabalans Oy, Hexal Ag, Biomo Pharma Gmbh, Stadapharm Gmbh, Viatris Germany Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 11 register entries
  • ZolpinoxHolsten Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ReminSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AmbienCosette Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC · 2 register entries
  • Ambien CRCosette Pharmaceuticals, Inc. · 1 register entry
  • EdluarViatris Specialty LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Stilnoct, Zolpeduar, Zolpidem Ab, Zolpidem Sandoz, Zolpidem Teva, Zolpidem Viatris, Zolpitop
Bulgaria
Адорма, Золcaна
Croatia
Lunata, Sanval, Zolsana
Cyprus
Stilnox
Czechia
Adorma, Hypnogen, Onirex, Sanval, Stilnox, Zolpidem, Zolpinox, Zolsana
Denmark
Stilnoct, Zolpidem Actavis, Zolpidem Forza, Zolpidem Hexal, Zolpidem Viatris, Zolpidem Vitabalans, Zonoct
Estonia
Hypnogen, Stilnox, Zolpidem Auxilia, Zolpidem Sandoz, Zolpidem Vitabalans, Zolsana
Finland
Somnor, Stella, Stilnoct, Zolpidem Vitabalans
France
Oratika, Stilnox, Zolpidem Almus, Zolpidem Arrow, Zolpidem Biogaran, Zolpidem Cristers, Zolpidem Eg, Zolpidem Sandoz, Zolpidem Teva, Zolpidem Viatris, Zolpidem Zentiva, Zolpidem Zydus
Greece
Hypnonorm, Oniria, Stilnox
Hungary
Hypnogen, Notilla, Sanval, Somnogen, Stilnox, Zolep, Zolpidem Ratiopharm, Zolpidem Vitabalans, Zolsana
Iceland
Edluar, Stilnoct
Ireland
Nytamel, Stilnoct, Zolnod, Zolpidem Tartrate Teva
Italy
Belirem, Nottem, Piurem, Quiem, Sonirem, Stilnox, Zolpeduar, Zolpidem Aurobindo, Zolpidem Doc Generici, Zolpidem Eg, Zolpidem P-Care, Zolpidem Pharmacare, Zolpidem Ratiopharm, Zolpidem Sandoz, Zolpidem Zentiva, Zolprem
Latvia
Hypnogen, Stilnox, Zolpidem Sandoz, Zolpidem Vitabalans, Zolsana
Lithuania
Hypnogen, Stilnox, Zolpidem Sandoz, Zolpidem Vitabalans, Zolsana
Luxembourg
Stilnoct, Zolpeduar, Zolpidem Eg, Zolpidem Viatris, Zolpitop
Malta
Stilnox, Zolpidem Aurobindo
Netherlands
Zolpidem Tartrate Ratiopharm, Zolpidemtartraat Aurobindo, Zolpidemtartraat Cf, Zolpidemtartraat Pch, Zolpidemtartraat Ratiopharm, Zolpidemtartraat Sandoz, Zolpidemtartraat Synthon, Zolpidemtartraat Teva, Zolpidemtartraat Viatris
Norway
Stilnoct, Zolpidem Actavis, Zolpidem Forza, Zolpidem Vitabalans
Poland
Apozolpin, Hypnogen, Nasen, Onirex, Polsen, Sanval, Stilnox, Zolpic, Zolpidem Genoptim, Zolpidem Vitabalans, Zolpigen, Zolsana
Portugal
Stilnox, Zolpidem Aurovitas, Zolpidem Generis, Zolpidem Ipca, Zolpidem Mylan, Zolpidem Ratiopharm, Zolpidem Sandoz, Zolpidem Tartrate Ratiopharm, Zolpidem Teva, Zolpidem Vitória
Romania
Stilnox, Zadobra, Zolpidem Atb, Zolsana
Slovakia
Hypnogen, Sanval, Stilnox, Zolpidem Fmk, Zolpidem Viatris, Zolpidem Vitabalans, Zolpinox
Slovenia
Perluna, Sanval, Zolpidem Vitabalans, Zolsana
Spain
Dagan, Dalparan, Stilnox, Zolpidem Aurovitas, Zolpidem Cinfa, Zolpidem Desgen, Zolpidem Normon, Zolpidem Ratiopharm, Zolpidem Sandoz, Zolpidem Stada, Zolpidem Teva-Ratiopharm, Zolpidem Tevagen, Zolpidem Viatris, Zolpidem Vir
Sweden
Edluar, Stilnoct, Zolpidem Forza, Zolpidem Hexal, Zolpidem Orifarm, Zolpidem Ratiopharm, Zolpidem Sandoz, Zolpidem Stada, Zolpidem Vitabalans

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. U.S. Food and Drug Administration. Zolpidem Tartrate (Sandoz Inc) – Prescribing Information, 2024-09-10. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0553e26c-f2aa-43aa-adf9-6eb951a501d3
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N05CF.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.