Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial.
Study Goal
The researchers aimed to evaluate the efficacy of melatonin in reducing sleep onset latency in children with autism spectrum disorder (ASD) under adequate sleep hygiene interventions.
Results Summary
Both 1-mg and 4-mg melatonin doses significantly shortened sleep onset latency compared to placebo (-22.0 and -28.0 minutes vs. -5.0 minutes, respectively; p < 0.0001 each). The study concluded that melatonin is a reasonable clinical approach for managing sleep difficulties in children with ASD.
Population
Children with autism spectrum disorder (ASD) (n = 196).
Effective Dosage
1-mg and 4-mg melatonin, administered once daily before bedtime.
Duration
Not specified in the abstract.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
1-mg melatonin | decrease | sleep onset latency (SOL) | children with autism spectrum disorder (ASD) | - 22.0 min | shortened significantly | #1 |
4-mg melatonin | decrease | sleep onset latency (SOL) | children with autism spectrum disorder (ASD) | - 28.0 min | shortened significantly | #2 |
placebo | decrease | sleep onset latency (SOL) | children with autism spectrum disorder (ASD) | - 5.0 min | shortened | #3 |
Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (- 22.0, - 28.0, and - 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD.