Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes.
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
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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.