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A sleep drug for kids just got a major regulatory boost. The FDA has granted Breakthrough Therapy designation to daridorexant (Quviviq) for insomnia in children and adolescents aged 10–17. Phase 2 data showed the 50mg dose added 50 minutes of sleep over placebo on day one — and even more in kids with neurodevelopmental disorders like ADHD or autism.
The FDA has granted Breakthrough Therapy designation to daridorexant — a dual orexin receptor antagonist already approved for adult insomnia under the brand name Quviviq — for the treatment of insomnia disorder in patients aged 10 to under 18. The designation reflects both the significant unmet need in this population and promising early clinical data.
The decision was backed by a phase 2 dose-finding trial of 165 adolescents with insomnia, including those with subthreshold neurodevelopmental disorders like autism spectrum disorder (ASD) and ADHD. Participants received daridorexant 10mg, 25mg, 50mg, or placebo once nightly, with total sleep time (TST) measured by polysomnography on day one.
By the Numbers:
Why it matters: Pediatric insomnia — especially in children with ASD or ADHD — is notoriously difficult to treat, with few approved pharmacological options. Daridorexant's favorable tolerability profile and meaningful sleep gains could fill a critical gap, with phase 3 trials now being planned.
