Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial

Introduction Insomnia disorder imposes a significant burden on children and adolescents; however, treatment options are limited. This paper describes the first controlled study to investigate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in children and adolescents with or without comorbid neurodevelopmental disorders, allowing its evaluation in a broad paediatric population.

Methods and analysis This multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding Phase 2 trial includes male and female participants aged ≥10 to Ethics and dissemination This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site.

Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal. Trial registration number NCT05423717 .