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Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes.

Journal of autism and developmental disorders
August 1, 2012
Beth Malow et al. (7 authors)
Controlled Clinical TrialJournal ArticleResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to assess the dose-response, tolerability, safety, and feasibility of collecting actigraphy data for supplemental melatonin in treating sleep onset insomnia in children with autism spectrum disorders (ASD).

Results Summary

Supplemental melatonin improved sleep latency in most children at 1 or 3 mg dosages, with effects evident in the first week and maintained over several months. It was well tolerated, safe, and showed improvements in sleep, behavior, and parenting stress.

Population

Children with autism spectrum disorders (ASD) who were free of psychotropic medications.

Effective Dosage

1 or 3 mg

Duration

14 weeks

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Supplemental melatonin
decrease
sleep onset insomnia
children with autism spectrum disorders (ASD)
-
has shown promise in treating
#1
Supplemental melatonin
decrease
sleep latency
most children
-
improved
#2
Supplemental melatonin
decrease
sleep latency
children
-
was effective in week 1 of treatment
#3
Supplemental melatonin
decrease
sleep latency
children
-
maintained effects over several months
#4
Supplemental melatonin
increase
tolerability
children
-
was well tolerated
#5
Supplemental melatonin
increase
safety
children
-
was safe
#6
Supplemental melatonin
increase
sleep
children
-
showed improvement in
#7
Supplemental melatonin
increase
behavior
children
-
showed improvement in
#8
Supplemental melatonin
decrease
parenting stress
parents
-
showed improvement in
#9
Abstract

Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose-response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures to detect change during a 14-week intervention. Supplemental melatonin improved sleep latency, as measured by actigraphy, in most children at 1 or 3 mg dosages. It was effective in week 1 of treatment, maintained effects over several months, was well tolerated and safe, and showed improvement in sleep, behavior, and parenting stress. Our findings contribute to the growing literature on supplemental melatonin for insomnia in ASD and inform planning for a large randomized trial in this population.

Medical Subject Headings (MeSH)
Autistic DisorderCentral Nervous System DepressantsChildChild, PreschoolFemaleHumansMaleMelatoninSleepSleep Wake DisordersTreatment Outcome
Study Links
Quality Scores
Safety85
Efficacy80/10
Quality70/10
Citation Metrics
Total Citations146
Citations/Year11.2
Relative Citation Ratio5.61
NIH Percentile94.2%
Research Impact Scores
APT Score0.95
Weight Score1.51
Normalized Score0.80
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