Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2009
The efficacy of melatonin for sleep problems in children with autism, fragile X syndrome, or autism and fragile X syndrome.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 82 papers, 7 of them syntheses that pooled it.
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
82 citing papers in PubMed, 7 syntheses or guidelines pooled it, 172 citations in OpenAlex.
- Pooled it
- Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review.CNS drugs · 2019Pooled it
- Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses.Developmental medicine and child neurology · 2019Pooled it
- Pooled it
- Systematic Review of Sleep Disturbances and Circadian Sleep Desynchronization in Autism Spectrum Disorder: Toward an Integrative Model of a Self-Reinforcing Loop.Frontiers in psychiatry · 2019Pooled it
- Public Health Literature Review of Fragile X Syndrome.Pediatrics · 2017Pooled it
- A practice pathway for the identification, evaluation, and management of insomnia in children and adolescents with autism spectrum disorders.Pediatrics · 2012Guideline
- The relationship between abdominal fat and sleep quality after combined exercise in patients with type 2 diabetes mellitus.Frontiers in endocrinology · 2025Trial
- Effects of Multi-Component Exercise on Sleep Quality in Middle-Aged Adults.International journal of environmental research and public health · 2022Trial
- Trial
- Trial
- Article
- Beyond challenging behaviors, sleep maintenance problems in autistic youth at the time of hospitalization are associated with increased caregiver strain.Sleep medicine · 2026Article
- Impact of physical activity on executive function in primary school children with autism spectrum disorder: a systematic review.International journal of developmental disabilities · 2026Review
- Parental report-based assessment of sleep problems and mental health in an unreferred cohort of children with a fragile X premutation.Frontiers in molecular neuroscience · 2026Article
- Autism Spectrum Disorder: Sleep Characteristics in Children and Adolescents, and Their Relationship with Probable Sleep Bruxism, Anxiety, and Cortisol and Melatonin Levels-A Cross-Sectional Study of Children in Brazil.Journal of autism and developmental disorders · 2025Article
- 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
- Preclinical Effects of Melatonin on the Development of Ehrlich's Tumor: A Biochemical, Cognitive, and Molecular Approach.Recent patents on anti-cancer drug discovery · 2025Article
- A Practice Pathway for the Treatment of Night Wakings in Children with Autism Spectrum Disorder.Journal of autism and developmental disorders · 2024Review
- Mitochondrial dysfunction in Fragile X syndrome and Fragile X-associated tremor/ataxia syndrome: prospect use of antioxidants and mitochondrial nutrients.Molecular biology reports · 2024Review
22 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 2 institutions in 3 countries.
Funding
Abstract
STUDY
objectiveTo determine the efficacy of melatonin on sleep problems in children with autistic spectrum disorder (ASD) and fragile X syndrome (FXS).
methodsA 4-week, randomized, double blind, placebo-controlled, crossover design was conducted following a 1-week baseline period. Either melatonin, 3 mg, or placebo was given to participants for 2 weeks and then alternated for another 2 weeks. Sleep variables, including sleep duration, sleep-onset time, sleep-onset latency time, and the number of night awakenings, were recorded using an Actiwatch and from sleep diaries completed by parents. All participants had been thoroughly assessed for ASD and also had DNA testing for the diagnosis of FXS.
resultsData were successfully obtained from the 12 of 18 subjects who completed the study (11 males, age range 2 to 15.25 years, mean 5.47, SD 3.6). Five participants met diagnostic criteria for ASD, 3 for FXS alone, 3 for FXS and ASD, and 1 for fragile X premutation. Eight out of 12 had melatonin first. The conclusions from a nonparametric repeated-measures technique indicate that mean night sleep duration was longer on melatonin than placebo by 21 minutes (p = .02), mean sleep-onset latency was shorter by 28 minutes (p = .0001), and mean sleep-onset time was earlier by 42 minutes (p = .02).
conclusionThe results of this study support the efficacy and tolerability of melatonin treatment for sleep problems in children with ASD and FXS.
Indexed as
Identifiers
19968048PMC2670334W2139507670What 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.