Idorsia Reports Positive Phase II Results for Paediatric Insomnia Drug

Idorsia has announced encouraging Phase II results for daridorexant, a dual orexin receptor antagonist, in treating paediatric insomnia disorder.

The trial evaluated doses of 10 mg, 25 mg, and 50 mg in 165 children aged 10 to under 18, including those with attention-deficit hyperactivity disorder and autism spectrum disorder. The study showed a statistically significant, dose-dependent increase in total sleep time from the first day of treatment.

Safety and tolerability were strong across all dose levels, with no signs of drug abuse, withdrawal symptoms, or next-morning drowsiness. Even at the highest dose, the safety profile was comparable to placebo.

The findings also suggest a potential role of orexin signalling in children with neurodevelopmental disorders, opening avenues for future therapies. The study is part of paediatric plans approved by global regulators, with further discussions planned on next development steps.

31-03-2026