Trial reportJournal of autism and developmental disorders2019
Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
Trial report in Journal of autism and developmental disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 2 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
54 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Melatonin and aggressive behavior: A systematic review of the literature on preclinical and clinical evidence.Journal of pineal research · 2022Pooled it
- International Expert Opinions and Recommendations on the Use of Melatonin in the Treatment of Insomnia and Circadian Sleep Disturbances in Adult Neuropsychiatric Disorders.Frontiers in psychiatry · 2021Pooled it
- The effect of oral melatonin on the quality of life, sleep and blood pressure of hemodialysis patients: a randomized clinical trial.BMC nephrology · 2025Trial
- Tasimelteon safely and effectively improves sleep in Smith-Magenis syndrome: a double-blind randomized trial followed by an open-label extension.Genetics in medicine : official journal of the American College of Medical Genetics · 2021Trial
- Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder.Journal of the American Academy of Child and Adolescent Psychiatry · 2021Trial
- Relationship Between Health-Related Behaviors and Family Quality of Life in Children with Autism Spectrum Disorder.Journal of autism and developmental disorders · 2026Article
- Sleep in Children with Neurodevelopmental Disorders: From Diagnostic Labels to Phenotype-directed Care.Current neurology and neuroscience reports · 2026Review
- Excitation/Inhibition Balance as a Mechanistic Link Between Sleep Disturbance and Autism Spectrum Disorder: A Bidirectional Framework.Alpha psychiatry · 2026Review
- From restless nights to peaceful sleep: mothers' lived experiences in dealing with sleep problems among children with autism spectrum disorder.BMC psychology · 2026Article
- An open science resource for accelerating scalable digital health research in autism and other neurodevelopmental conditions.Nature neuroscience · 2026Article
- Parallel paths: A narrative review exploring autism and its co-occurring conditions.World journal of clinical pediatrics · 2025Review
- Evaluation and treatment of sleep disorders in adolescents with depression; a scoping review.BMC psychiatry · 2025Article
- Protocol MelatoSom-Kids-PTSD: sleep disturbances in children and adolescents with post-traumatic stress disorder (PTSD) - a randomized double-blind placebo-controlled trial to investigate the efficacy of paediatric prolonged-release melatonin.European journal of psychotraumatology · 2025Article
- Melatonin use in the pediatric population: an evolving global concern.World journal of pediatrics : WJP · 2025Review
- 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
- 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
- Sleep Disorders in Children with Autism Spectrum Disorder: Developmental Impact and Intervention Strategies.Brain sciences · 2025Review
- 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
- Assessment of Serum Melatonin Levels, Sleep Patterns, and Clinical Symptoms in Children With Autism Spectrum Disorder: A Case-Control Study.Psychiatry investigation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2-5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver's quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers' quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers' quality of life.
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.