Section 10 · Monograph
Daridorexant
Reviewed Nov 2026FDA label
QuviviqOrexin receptor antagonist
- Forms
- Tab: 25, 50mg
- Dose
- 25-50mg qHS within 30 min of bed (7+ hours before waking)
- MOA
- Blocks orexin OX1R/OX2R-mediated wakefulness
Indications
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adultsFDA-labeled
Mechanism of Action
- Dual orexin receptor antagonist (OX1R and OX2R) that suppresses wake-promoting orexin signaling
Full Dosing
Adult / usual
- 25-50mg once nightly within 30 minutes of going to bed with at least 7 hours remaining before planned awakening
- Moderate CYP3A4 inhibitors: maximum 25mg; strong CYP3A4 inhibitors: avoid; strong or moderate inducers: avoid
- Avoid taking with or soon after a meal (may delay onset); Schedule IV
Hepatic
- Moderate hepatic impairment: maximum 25mg; severe hepatic impairment: not recommended
Contraindications
- Narcolepsy
Drug Interactions
- CYP3A4 inhibitors and inducers alter exposure
- Additive CNS depression with alcohol and other sedatives
Adverse Effects
- Headache, somnolence and fatigue
- Next-day impairment including driving
- Complex sleep behaviors (sleepwalking, sleep-driving)
- Sleep paralysis, hypnagogic hallucinations and cataplexy-like symptoms
- Worsening depression or suicidal ideation
Monitoring Parameters
- Next-day alertness and driving safety
- Mood and suicidal ideation
- Emergence of complex sleep behaviors
Pregnancy & Lactation
- Limited human data; use only if benefit justifies risk
- Excretion in human milk not established