FDA Grants Breakthrough Therapy Designation to Daridorexant for Insomnia in Patients Ages 10 to Under 18
Swiss biopharmaceutical company Idorsia announced on November 4, 2026 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its insomnia drug daridorexant for the treatment of insomnia disorder in patients aged 10 to under 18. It is the first such expedited designation for a pediatric insomnia medicine, and no drug treatment is currently approved by the FDA for this age group.
Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious conditions where preliminary clinical evidence indicates a substantial improvement on a clinically significant endpoint. The designation gives Idorsia intensive FDA guidance and more frequent interaction. Daridorexant is a dual orexin receptor antagonist that selectively reduces wake drive rather than broadly inhibiting brain activity; its efficacy in adults at 25 mg and 50 mg doses was published in The Lancet Neurology.
The designation rests on a multicenter, randomized, double-blind, placebo-controlled Phase 2 dose-finding study (NCT05423717) in which 165 children and adolescents aged 10 to under 18 with insomnia disorder received daridorexant 10 mg, 25 mg or 50 mg, or placebo, over two weeks, with objective total sleep time measured by polysomnography as the primary endpoint. The study showed a statistically significant dose-dependent improvement in total sleep time (p=0.0185); a single 50 mg dose increased sleep time by 50 minutes overall and by 64 minutes in patients with neurodevelopmental disorders, with a numerical decrease in morning sleepiness. Even at 50 mg, the highest recommended adult dose, tolerability remained similar to placebo, with no adverse events denoting drug abuse and no indication of withdrawal symptoms on discontinuation.
Pediatric insomnia, characterized by difficulty initiating or maintaining sleep with significant daytime impairment, has a prevalence of about 8 to 12 percent and a particularly high burden in patients with neurodevelopmental disorders such as autism spectrum disorder and ADHD. Idorsia Chief Medical Officer Amer Joseph said the designation underscores the significant unmet medical need and the encouraging clinical evidence, and that daridorexant could become the first FDA-approved pharmacological treatment for pediatric insomnia disorder.
Idorsia noted that daridorexant for pediatric use is investigational and is not approved or marketed in any country. The full dataset manuscript is under evaluation at a high-impact scientific journal, and the company expects to initiate its Phase 3 program in the second half of 2027. (Source: Idorsia Ltd)
Source: Idorsia Ltd
Published by GSM · USA (original Chinese edition)
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