Idorsia’s daridorexant delivers outstanding results in a Phase 2 study in children with insomnia disorder

Core Insights - Idorsia Ltd announces positive top-line results from its Phase 2 dose-finding study of daridorexant in pediatric patients with insomnia disorder, demonstrating a statistically significant dose-dependent improvement in total sleep time [2][4][10] Study Overview - The Phase 2 study aimed to characterize the dose-response relationship of daridorexant on total sleep time using polysomnography, with 165 patients randomized to receive either daridorexant (10, 25, or 50 mg) or placebo for two weeks [4][10] - The study included children aged 10 to 17 years, with 21% aged 10-11 years and 79% aged 12-17 years, including those with neurodevelopmental disorders like Autism Spectrum Disorder and ADHD [5][10] Safety and Tolerability - The study confirmed the excellent safety and tolerability profile of daridorexant in pediatric patients, with no adverse events indicating drug abuse and no withdrawal symptoms upon discontinuation [6][10][11] - Even at the highest tested dose of 50 mg, daridorexant's safety profile was similar to that of placebo, with no residual sleepiness reported [11] Implications for Neurodevelopmental Disorders - Results suggest that orexin signaling may play a broader role in children with neurodevelopmental disorders, potentially opening new therapeutic avenues [7][12] - The findings are particularly significant given the lack of FDA-approved medications for pediatric insomnia and the safety concerns associated with off-label drug use [9][11] Next Steps - Idorsia plans to engage with health authorities to discuss the next steps in pediatric insomnia and explore the potential of daridorexant for children with neurodevelopmental disorders [10][12] - Detailed results will be shared at upcoming congresses and in peer-reviewed publications [13]