ArticleBMJ open2026
Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05423717 (Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInsomnia 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. The change from baseline to Day 1 in total sleep time, measured by polysomnography, is the primary endpoint used to characterise the dose-response relationship of daridorexant in paediatric subjects with insomnia disorder. The study also assesses the safety, tolerability, pharmacokinetics, palatability and acceptability of daridorexant. 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.