Trial reportJournal of autism and developmental disorders2022
Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial.
Trial report in Journal of autism and developmental disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 45 citations in OpenAlex.
- Autism spectrum disorder across the lifespan: Dynamic symptom trajectories and multidimensional support framework.Molecular psychiatry · 2026Review
- Towards Mechanism-Informed Treatments for Mental Health.Journal of neurochemistry · 2026Review
- Comparative efficacy and acceptability of sleep interventions for children and adolescents with autism spectrum disorders: a protocol for a systematic review and network meta-analysis.Systematic reviews · 2026Article
- Exploring Occupational Therapists' Sleep Intervention Approaches and Perspectives for Children With Autism Spectrum Disorder: A Malaysian Qualitative Study.Occupational therapy international · 2026Article
- Article
- Melatonin use in the pediatric population: an evolving global concern.World journal of pediatrics : WJP · 2025Review
- Comment on Paditz et al. The Pharmacokinetics, Dosage, Preparation Forms, and Efficacy of Orally Administered Melatonin for Non-Organic Sleep Disorders in Autism Spectrum Disorder During Childhood and Adolescence: A Systematic Review.Children (Basel, Switzerland) · 2025Article
- Reply to Gringras et al. Comment on "Paditz et al. The Pharmacokinetics, Dosage, Preparation Forms, and Efficacy of Orally Administered Melatonin for Non-Organic Sleep Disorders in Autism Spectrum Disorder During Childhood and Adolescence: A Systematic Review.Children (Basel, Switzerland) · 2025Article
- The Efficacy of Melatonergic Receptor Agonists Used in Clinical Practice in Insomnia Treatment: Melatonin, Tasimelteon, Ramelteon, Agomelatine, and Selected Herbs.Molecules (Basel, Switzerland) · 2025Review
- Sleep Disorders in Children with Autism Spectrum Disorder: Developmental Impact and Intervention Strategies.Brain sciences · 2025Review
- Parent stress reduction interventions and sleep problems in autistic youth.Research in autism · 2025Article
- Melatonin Interventions in Autism Spectrum Disorder: Sleep Regulation, Behavioral Outcomes, and Challenges Across the Lifespan.Molecular neurobiology · 2025Review
- The Pharmacokinetics, Dosage, Preparation Forms, and Efficacy of Orally Administered Melatonin for Non-Organic Sleep Disorders in Autism Spectrum Disorder During Childhood and Adolescence: A Systematic Review.Children (Basel, Switzerland) · 2025Review
- Sleep and psychiatric disorders: Bidirectional interactions and shared neurobiological mechanisms.PLOS mental health · 2025Review
- Pharmacological management of pediatric insomnia.Frontiers in sleep · 2024Review
- Management of sleep disorders in autism spectrum disorder with co-occurring attention-deficit hyperactivity disorder: update for clinicians.BJPsych open · 2023Review
- The short-term and long-term adverse effects of melatonin treatment in children and adolescents: a systematic review and GRADE assessment.EClinicalMedicine · 2023Article
- Parental Experiences of Melatonin Administration to Manage Sleep Disturbances in Autistic Children and Adolescent in the UK.Healthcare (Basel, Switzerland) · 2023Article
- Problems in the Development of the Sleep-Wake Rhythm Influence Neurodevelopmental Disorders in Children.Diagnostics (Basel, Switzerland) · 2023Review
- Role of Melatonin in the Management of Sleep and Circadian Disorders in the Context of Psychiatric Illness.Current psychiatry reports · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (- 22.0, - 28.0, and - 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD.
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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.