Daridorexant, Orexin Receptor Agonist, Shows Positive Results in Pediatric Insomnia

As orexin agonists evolve in the sleep disorder space, daridorexant addresses the pediatric side of insomnia. The drug met its primary endpoint in phase 2, increasing objective total sleep time by 50 minutes from baseline, with a favorable safety profile.

The phase 2 study of daridorexant in children and adolescents was a randomized, double-blind, placebo-controlled dose-finding study. The trial evaluated 10, 25, and 50 mg doses of daridorexant compared with placebo over 2 weeks in pediatric patients aged 10 to 18 years. Participants included 165 children and adolescents with DSM-5 diagnosed insomnia, over half of whom also had diagnosed or subthreshold autism spectrum disorder and/or attention-deficit hyperactivity disorder (ADHD). The primary endpoint was change from baseline in total sleep time, measured by polysomnography. Other assessments included subjective sleep measures, sleep quality, morning sleepiness and alertness, daytime functioning, pharmacokinetics, safety, and tolerability.

Carmen M. Schroder, MD, PhD, shared in a press release that “the efficacy findings are compelling, and the favorable safety and tolerability results add to our confidence in taking the next steps. The highest recommended adult dose was studied in children, including those with lower body weight, with no new safety findings observed. This provides a strong foundation for the future development of daridorexant in pediatric populations.”

The trial showed a 50 mg dose increased sleep time by 50 minutes overall, and 64 minutes specifically in participants with neurodevelopmental disorders. “The compelling results in children with insomnia and ADHD and/or ASD as well as in children without neurodevelopmental disorders allow us to target a broad and underserved pediatric population,” said Amer Joseph, MD, chief medical officer and head of global clinical development and medical affairs at Idorsia. Dose-dependent improvement across objective and subjective sleep measures was statistically significant (P = 0.0185) from baseline to day 1. Safety and tolerability measures were confirmed, even with the 50 mg dose which is the recommended adult dose. No adverse events related to drug abuse during treatment or withdrawal symptoms after treatment were reported.

Daridorexant is a dual orexin receptor agonist that works to promote restorative sleep throughout the night, reducing morning sleepiness and improving daytime functioning. It is the first investigational drug in its class to demonstrate positive results in pediatric insomnia. The drug is currently marketed by Idorsia Pharmaceuticals as Quviviq for adults with insomnia, approved in North America and Europe; it is not currently approved for pediatric use in any country.

A phase 3 clinical development program is being developed and planned for initiation in the second half of 2027.

References

1. Idorsia presents outstanding results with daridorexant in children and adolescents with insomnia and an expanding body of evidence in adults at Sleep Europe 2026. Press release. October 23, 2026. Accessed October 26, 2026. https://www.idorsia.com/media/news/news-archive/media-release-details?id=3790219

2. Dose-finding study assessing the efficacy, safety, and pharmacokinetics of daridorexant in subjects aged 10 to < 18 years with insomnia disorder. ClinicalTrials.gov. March 6, 2026. Accessed October 26, 2026. https://clinicaltrials.gov/study/NCT05423717