The U.S. Food and Drug Administration (FDA) has approved daridorexant (Quviviq, Idorsia) 25 mg and 50 mg for the treatment of adult patients with insomnia. Daridorexant is a dual orexin receptor antagonist (DORA). By blocking orexin receptors, and particularly orexin 2 receptors, DORAs are throught to prevent orexin from promoting the release of other wake-promoting neurotransmitters. The approval comes after two positive phase 3 studies. Results from two multicenter, randomized, double-blind, placebo-controlled studies showed a dose-dependent effect on reducing Wake After Sleep Onset (WASO) and latency to sleep onset (Latency to Persistent Sleep (LPS), versus placebo.
Both daridorexant 25 mg and 50 mg improved sleep outcomes. Consistent with the US prescribing information, the 50 mg dose of daridorexant, which was evaluated in one of the two pivotal studies, demonstrated a significant reduction in patient-reported daytime sleepiness, using a validated instrument. The most common adverse reactions reported were headache (25 mg: 6%; 50 mg: 7%) and somnolence and fatigue (25 mg: 6%; 50 mg: 5%). Daridorexant has an approximate half-life of 6 hours.
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