Insomnia in children and adolescents, particularly when it coexists with autism spectrum disorder or ADHD, has long been treated with a patchwork of behavioral strategies, melatonin, and off-label medications never formally tested in pediatric trials. New Phase 2 results for daridorexant — a dual orexin receptor antagonist already approved for adults under the brand name Quviviq — suggest that may be starting to change. The data, from Swiss biopharmaceutical company Idorsia, are set for presentation in a late-breaking session at Sleep Europe 2026, the European Sleep Research Society's congress running October 20–23 in Maastricht, the Netherlands.
A Two-Week, Placebo-Controlled Test in Children
The trial randomized 165 patients ages 10 to 17 — about 21% between 10 and 11 years old, and 79% between 12 and 17 — to one of three doses of daridorexant (10, 25, or 50 mg) or placebo for two weeks. Critically, the enrolled population included a substantial share of children with co-occurring neurodevelopmental disorders, including autism spectrum disorder and ADHD — exactly the group for whom insomnia is common and treatment options are thinnest.
The primary endpoint was objective total sleep time measured by polysomnography, the gold-standard overnight sleep study that uses electrodes to directly record brain activity, rather than relying on parent-reported sleep diaries. On Day 1, total sleep time improved from baseline in a dose-dependent manner (p=0.0185), with the company reporting dose-dependent gains across several other objective and subjective sleep measures as well.
Bigger Gains in Kids With Autism and ADHD
The most notable finding in the dataset is not just that the drug worked, but who it worked best for. Idorsia reports that efficacy was especially pronounced in children with co-morbid neurodevelopmental disorders — a population in which insomnia is both more prevalent and more disruptive to daytime functioning, family routines, and other therapies, but for whom few medications have been rigorously studied in controlled trials.
Safety at the Highest Dose
On safety, the company describes the profile at the top 50 mg dose as similar to placebo, with no signals of drug abuse potential or withdrawal effects after the medication was stopped. Idorsia frames this as the first confirmation of daridorexant's safety and tolerability in a pediatric population, including at the highest tested dose — a meaningful marker given how cautiously regulators and clinicians approach new sleep medications in children, where the long-term effects of chronic treatment are far less established than in adults.
Part of a Broader Push for Pediatric Insomnia Data
The pediatric results arrive alongside additional adult and real-world daridorexant data that Idorsia is presenting at the same congress, reflecting a broader effort to expand the drug's evidence base beyond the original adult insomnia trials that led to its approval. Idorsia has said it will now engage with health authorities on next steps for a pediatric insomnia indication, and separately plans to discuss a potential dedicated investigation pathway for children with neurodevelopmental disorders — a population that existing trial designs and regulatory frameworks have historically underserved.
It's worth noting these are top-line results from a company announcement and conference presentation rather than a peer-reviewed publication, so independent replication and full statistical detail — including effect sizes beyond the headline p-value — will matter once the complete dataset is published.
What This Means for Patients
For families managing a child's insomnia alongside autism or ADHD, treatment options have mostly meant trial-and-error with melatonin, sedating antihistamines, or off-label use of adult sleep medications never tested in that age group. A dual orexin receptor antagonist with a dedicated, controlled pediatric trial — and a safety profile that held up even at the highest dose — represents a meaningfully different starting point.
That said, parents and clinicians should wait for the full peer-reviewed data and, eventually, an FDA decision on pediatric labeling before treating this as a ready-to-prescribe option. Phase 2 success does not guarantee Phase 3 confirmation or regulatory approval, and two weeks of data cannot speak to the effects of months or years of use in a developing brain. For now, the results are best read as a promising first step toward a long-overdue evidence base for one of pediatric sleep medicine's most under-researched, and most commonly co-occurring, conditions.
