Daridorexant Reference

Plain English

What it is

Daridorexant, sold as Quviviq, is a prescription sleep medicine that the FDA approved for adults with insomnia, meaning trouble falling asleep or staying asleep. It is a controlled substance (Schedule IV). It belongs to a newer group of sleep drugs called orexin-receptor antagonists, which work by quieting a wake-promoting brain signal instead of broadly sedating the brain the way older sleep pills do.

What people use it for

It is used by adults who have insomnia and need help with falling asleep or staying asleep. It is one of a small group of orexin-blocking sleep drugs available by prescription.

What the science shows

In two large, carefully controlled trials, people taking it fell asleep faster, stayed asleep longer, and slept more overall compared with a placebo (a dummy pill). The researchers described its overall safety record as favourable.

The catch

It is a controlled substance with real tradeoffs. The label warns it can cause next-day drowsiness and can impair driving and alertness. It can also trigger complex sleep behaviors such as sleepwalking and sleep-driving while a person is not fully awake, along with sleep paralysis, vivid and disturbing hallucinations, cataplexy-like symptoms, and possible worsening of depression or suicidal thoughts. It is available only with a prescription.

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 35065036), 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