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 <18 years meeting the diagnosis of insomnia disorder as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria. The study population is stratified into three groups: those with a known diagnosis of autism spectrum disorder (ASD) or attention-deficit hyperactivity disorder (ADHD); those without a diagnosis of ASD/ADHD but who meet the definition of ‘subthreshold ASD’ or ‘subthreshold ADHD’; those with neither diagnosed ASD/ADHD nor ‘subthreshold’ ASD/ADHD.
Study participants are randomised 1:1:1:1 to daridorexant 10 mg, 25 mg, 50 mg or placebo for at least 14 days.
BMJ Open published a clinical update in Research Highlights on 06 Apr 2026.
The item focuses on Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial.
Review the original article for the full source wording and details.