For research and educational purposes only. Not medical advice.
Daridorexant Reference
Educational, not medical advice reference for Daridorexant: Sleep; regulatory status, evidence posture, source review, and schedule notes. Also…
Reference summary
Pivotal evidence is Mignot 2022 Lancet Neurology (two multicentre randomized double-blind placebo-controlled Phase 3 trials in adult and elderly insomnia patients, PMID 35139072), which reported improvements in sleep-onset latency, wake-after-sleep-onset, and self-reported total sleep time at both 25 mg and 50 mg nightly doses versus placebo. Daridorexant's shorter half-life (approximately 8 hours) versus suvorexant was a design objective intended to reduce next-day carryover, though the label still carries somnolence and driving-impairment warnings.
Regulatory and posture
- Categories
- Sleep
- Aliases
- Quviviq, ACT-541468, Dual orexin receptor antagonist (DORA, small molecule, not a peptide)
- Evidence posture
- human - Same class-level next-day-somnolence and complex-sleep-behavior warnings as the other DORAs. Schedule IV controlled substance. Avoid concurrent strong CYP3A4 inhibitors.
- Regulatory status
- FDA-approved as Quviviq (January 2022, Idorsia Pharmaceuticals) for the treatment of adults with insomnia characterized by difficulties with sleep onset and / or sleep maintenance. Schedule IV controlled substance under the US Controlled Substances Act. Third dual orexin receptor antagonist (DORA) approved in the United States after suvorexant (Belsomra, 2014) and lemborexant (Dayvigo, 2019).
- Content review status
- label verified