Dual orexin receptor antagonist Pregnancy: Should be used during pregnancy only if the clinical condition of the pregnant woman requires treatment with daridorexant (§4.6). There are no data on use in pregnant women; animal studies did not indicate harmful effects with respect to reproductive toxicity. Breast-feeding: presence in breast milk is low (0.02% of the maternal dose in a study of 10 healthy lactating women receiving 50 mg), but a risk of excessive somnolence to the breastfed infant cannot be excluded — decide whether to discontinue breast-feeding or the medicine. Fertility: no human data; animal studies indicate no impact on male or female fertility.

Daridorexant

Brand names: Quviviq

Daridorexant is an orexin receptor antagonist licensed for the treatment of insomnia characterised by symptoms present for several months with substantial impact on daytime functioning.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 50 mg once per night (one 50 mg tablet); based on clinical judgement, some patients may be treated with 25 mg once per night

Route: Oral — taken in the evening within 30 minutes before going to bed; can be taken with or without food, although taking it soon after a large meal may reduce the effect on sleep onset

Frequency: Once per night

Max: 50 mg daily (the maximum daily dose is 50 mg)

Source: UK SPC (eMC) for QUVIVIQ 25 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/15359/smpc). Indication per this SPC is insomnia. The treatment duration should be as short as possible; the appropriateness of continued treatment should be assessed within 3 months and periodically thereafter. Clinical data are available for up to 12 months of continuous treatment. Treatment can be stopped without down-titration. MISSED DOSE: if a patient forgets to take it at bedtime, that dose should not be taken during the night. HEPATIC IMPAIRMENT: mild — no dose adjustment; moderate — recommended dose is 25 mg once per night; severe — not studied and not recommended. CO-ADMINISTRATION WITH MODERATE CYP3A4 INHIBITORS: recommended dose is 25 mg once per night; consumption of grapefruit or grapefruit juice in the evening should be avoided. CNS DEPRESSANTS: dose adjustments of daridorexant and/or the other medicinal product may be required, based on clinical evaluation, due to potentially additive effects. ELDERLY: no dose adjustment required (> 65 years); limited data in patients older than 75 years and no data in patients older than 85 years. PAEDIATRIC: safety and efficacy in paediatric patients have not yet been established and no data are available (no per-kg dose is stated, hence paedDose is null) — verify any under-18 use against a children's formulary. The eMC bundle did not include §4.5, so the interactions listed below are taken from the US FDA label §7 (openFDA) plus the §4.2/§4.3 statements — verify against the UK SPC §4.5. Note the US §7 text was truncated at the source-fetch limit.

Dose adjustments

Renal

In patients with renal impairment (including severe), no dose adjustment is required (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Narcolepsy
Concomitant use with strong CYP3A4 inhibitors

Side effects

Headache (common) — one of the two most frequently reported adverse reactions
Somnolence (common) — reported in 3% and 2% of subjects on 25 mg and 50 mg respectively vs 2% on placebo
Dizziness (common)
Nausea (common) and fatigue (common)
Sleep paralysis, hallucination, abnormal dreams/nightmares and somnambulism (uncommon) — sleep paralysis and hallucinations occur mainly during the first weeks of treatment; hypersensitivity including rash and urticaria (uncommon)

Interactions

Strong CYP3A4 inhibitors — concomitant use is contraindicated (§4.3); the US label states concomitant use is not recommended
Moderate CYP3A4 inhibitors — increase daridorexant exposure; the recommended dose is 25 mg once per night (§4.2). Avoid grapefruit or grapefruit juice in the evening
Strong or moderate CYP3A4 inducers — decrease daridorexant exposure and may reduce efficacy; concomitant use is not recommended (US label §7.1)
Alcohol and other CNS depressants — potentially additive effects; dose adjustment of daridorexant and/or the other medicinal product may be required based on clinical evaluation (§4.2, §4.4)

Clinical monograph

How it works

It blocks orexin (hypocretin) OX1 and OX2 receptors, reducing the wake-promoting orexin signal to facilitate sleep.

Prescribing in practice

It can impair next-day driving and alertness, and patients should be warned not to drive if they feel drowsy; effects are additive with alcohol and other CNS depressants.
Use is contraindicated in narcolepsy and caution is needed in patients with a history of substance misuse.
Dose adjustment or avoidance is required in significant hepatic impairment and with strong CYP3A4 inhibitors.

Monitoring

Monitor treatment response, daytime sleepiness and the continued need for therapy rather than by laboratory tests.

Counselling the patient

Take it shortly before bed when you can have a full night's sleep.
You may feel drowsy the next day; do not drive if affected.
Avoid alcohol while taking this medicine.

Evidence & guidelines

Daridorexant's efficacy in insomnia is supported by randomised controlled trials, and NICE has appraised its use.

Reference: NICE TA922; NICE CKS Insomnia; DVLA; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways