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Sleep Disorders Pregnancy: Avoid — limited human data; sleep disturbance in pregnancy managed with non-pharmacological approaches first; consult specialist if pharmacotherapy required

Daridorexant

Brand names: Quviviq

Adult dose

Dose: 25–50 mg orally at bedtime
Route: Oral
Frequency: Once nightly (within 30 minutes of bedtime)
Max: 50 mg per night
Take no more than once per night. Allow 7 hours before activities requiring full alertness (driving). Start at 25 mg; increase to 50 mg if needed. Swallow whole. Available as 25 mg and 50 mg tablets.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: Oral
Frequency: N/A
Max: N/A
Not established in paediatrics; sleep disorder management in children requires specialist assessment

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment in mild impairment; 25 mg maximum in moderate impairment; avoid in severe hepatic impairment

Paediatric weight-based calculator

Not established in paediatrics; sleep disorder management in children requires specialist assessment

Clinical pearls

  • Mechanism: dual orexin receptor antagonist (DORA) — blocks both OX1R and OX2R (also called hypocretin receptors); orexin promotes wakefulness; blocking orexin signalling passively allows sleep onset; different from GABA-potentiating drugs (benzodiazepines, Z-drugs)
  • DORA advantage: does not suppress REM sleep or slow-wave sleep (unlike benzodiazepines and Z-drugs); preserves normal sleep architecture; lower dependence and abuse potential; no rebound insomnia on stopping
  • IDARED trials (Lancet 2022): daridorexant 25 mg and 50 mg vs placebo in chronic insomnia — significant improvements in subjective sleep onset latency, wake after sleep onset, and daytime functioning; improvements sustained over 3 months
  • MHRA 2022: first DORA licensed in UK for chronic insomnia in adults; positioned as alternative to Z-drugs (zopiclone/zolpidem) with better safety profile for long-term use
  • Narcolepsy contraindication: orexin/hypocretin deficiency is the neurobiological basis of narcolepsy Type 1; DORAs would theoretically worsen narcolepsy by further blocking residual orexin signalling
  • MHRA: not a controlled drug (Class C scheduled like Z-drugs) — however, complex sleep behaviours (sleepwalking) require counselling; lower abuse potential than benzodiazepines

Contraindications

  • Narcolepsy (orexin deficiency — DORA is mechanistically contraindicated)
  • Known hypersensitivity to daridorexant
  • Strong CYP3A4 inhibitors (significant increase in exposure — avoid or use 25 mg maximum)

Side effects

  • Somnolence/headache (most common)
  • Dizziness
  • Fatigue
  • Sleep paralysis (rare — orexin system modulation)
  • Complex sleep behaviours (rare — sleepwalking, sleep eating)
  • Next-day residual sedation (lower than Z-drugs at approved doses)

Interactions

  • Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) — increase daridorexant AUC by up to 6-fold; avoid or use 25 mg maximum with careful monitoring
  • Strong CYP3A4 inducers (rifampicin, carbamazepine) — reduce daridorexant exposure significantly; may reduce efficacy
  • CNS depressants (alcohol, opioids, benzodiazepines) — additive sedation

Monitoring

  • Subjective sleep quality (sleep diary — onset latency, wake after sleep onset)
  • Daytime functioning and next-day alertness
  • Complex sleep behaviours (sleepwalking — instruct patient to report)
  • LFTs (hepatic impairment monitoring)

Reference: BNFc; BNF 90; IDARED trials Lancet 2022;400(10349):347-356; MHRA 2022 approval; ESC Insomnia Guidelines. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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