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daridorexant

Quviviq · ATC code N05CJ03

Key facts
Active substance
daridorexant
Drug class
Hypnotics and sedatives
ATC code
N05CJ03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
QUVIVIQ 25 mg film-coated tablets / QUVIVIQ 50 mg film-coated tablets
Marketing authorisation holder
Idorsia Pharmaceuticals Deutschland GmbH
Information as of
2026-10-27

Key facts

Daridorexant is an orexin receptor antagonist that reduces wakefulness. It is used to treat chronic insomnia in adults.

What it is used for

  • Adults with insomnia with symptoms present for at least 3 months and considerable impact on daytime functioning

Dosing

  • Recommended: 50 mg once per night, taken in the evening within 30 minutes before going to bed
  • Based on clinical judgement some patients may take 25 mg; maximum daily dose 50 mg
  • Treatment as short as possible; reassess within 3 months and periodically thereafter
  • Moderate hepatic impairment: 25 mg; severe hepatic impairment: not recommended; renal impairment: no adjustment
  • With moderate CYP3A4 inhibitors: 25 mg
  • Can be stopped without down-titration; a missed dose should not be taken during the night

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Narcolepsy
  • Concomitant use with strong CYP3A4 inhibitors

Important warnings

  • Elderly: caution because of fall risk; limited data in patients older than 75 years
  • CNS-depressant effects: caution with driving or operating machinery, especially in the first days
  • Caution with other CNS depressants and alcohol
  • Sleep paralysis, hypnagogic/hypnopompic hallucinations and cataplexy-like symptoms may occur

Side effects

  • Most frequent: headache and somnolence
  • Most adverse reactions were mild to moderate

Interactions

  • Strong CYP3A4 inhibitors (e.g. itraconazole, clarithromycin, ritonavir): contraindicated
  • Moderate CYP3A4 inhibitors (e.g. erythromycin, ciprofloxacin, cyclosporine): dose 25 mg; avoid grapefruit in the evening
  • CYP3A4 inducers (e.g. efavirenz) markedly reduce exposure

Pregnancy and breastfeeding

  • No data in pregnancy; use only if the clinical condition requires treatment
  • Only a very small fraction of the dose passes into breast milk

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

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

  • QuviviqIdorsia Pharmaceuticals Deutschland GmbH · EMEA/H/C/005634

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Quviviq
Liechtenstein
Quviviq
Norway
Quviviq

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

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

Another question about this substance?

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

Sources

  1. European Medicines Agency. Quviviq – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/quviviq-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N05CJ.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.