Trial reportPsychopharmacology2010
Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT.
Trial report in Psychopharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 5 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
30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 108 citations in OpenAlex.
- Hypnotic and Melatonin/Melatonin-Receptor Agonist Treatment in Bipolar Disorder: A Systematic Review and Meta-Analysis.CNS drugs · 2022Pooled it
- Guideline
- Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review.CNS drugs · 2019Pooled it
- Clinical Practice Guideline for the Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders: Advanced Sleep-Wake Phase Disorder (ASWPD), Delayed Sleep-Wake Phase Disorder (DSWPD), Non-24-Hour Sleep-Wake Rhythm Disorder (N24SWD), and Irregular Sleep-Wake Rhythm Disorder (ISWRD). An Update for 2015: An American Academy of Sleep Medicine Clinical Practice Guideline.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2015Guideline
- Pooled it
- Trial
- Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial.BMJ (Clinical research ed.) · 2012Trial
- Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia.Psychopharmacology · 2011Trial
- Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine.Children (Basel, Switzerland) · 2025Review
- Melatonin use in the pediatric population: an evolving global concern.World journal of pediatrics : WJP · 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
- Melatonin Use in Pediatric Intensive Care Units: A Single-Center Experience.Medical sciences (Basel, Switzerland) · 2023Article
- The short-term and long-term adverse effects of melatonin treatment in children and adolescents: a systematic review and GRADE assessment.EClinicalMedicine · 2023Article
- Use of melatonin in children and adolescents with idiopathic chronic insomnia: a systematic review, meta-analysis, and clinical recommendation.EClinicalMedicine · 2023Article
- Melatonin Use in Infants Admitted to Intensive Care Units.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Current Insights into the Risks of Using Melatonin as a Treatment for Sleep Disorders in Older Adults.Clinical interventions in aging · 2023Review
- Melatonin Treatment for Pediatric Patients with Insomnia: Is There a Place for It?Nature and science of sleep · 2022Review
- Sleep's role in the development and resolution of adolescent depression.Nature reviews psychology · 2022Review
- Circadian Rhythm Sleep-Wake Disorders: a Contemporary Review of Neurobiology, Treatment, and Dysregulation in Neurodegenerative Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- Melatonin Use in Pediatrics: Evaluating the Discrepancy in Evidence Based on Country and Regulations Regarding Production.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationalePharmacokinetics of melatonin in children might differ from that in adults.
objectivesThis study aims to establish a dose-response relationship for melatonin in advancing dim light melatonin onset (DLMO), sleep onset (SO), and reducing sleep onset latency (SOL) in children between 6 and 12 years with chronic sleep onset insomnia (CSOI).
methodsThe method used for this study is the randomized, placebo-controlled double-blind trial. Children with CSOI (n = 72) received either melatonin 0.05, 0.1, and 0.15 mg/kg or placebo during 1 week. Sleep was assessed with log and actigraphy during this week and the week before. Outcomes were the shifts in DLMO, SO, and SOL.
resultsTreatment with melatonin significantly advanced SO and DLMO by approximately 1 h and decreased SOL by 35 min. Within the three melatonin groups, effect size was not different, but the circadian time of administration (TOA) correlated significantly with treatment effect on DLMO (r (s) = -0.33, p = 0.022) and SO (r (s) = -0.38, p = 0.004), whereas clock TOA was correlated with SO shift (r = -0.35, p = 0.006) and not with DLMO shift.
conclusionsNo dose-response relationship of melatonin with SO, SOL, and DLMO is found within a dosage range of 0.05-0.15 mg/kg. The effect of exogenous melatonin on SO, SOL, and DLMO increases with an earlier circadian TOA. The soporific effects of melatonin enhance the SO shift. This study demonstrates that melatonin for treatment of CSOI in children is effective in a dosage of 0.05 mg/kg given at least 1 to 2 h before DLMO and before desired bedtime.
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.