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Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized

Masaharu Hayashi1, Kazuo Mishima2, Michio Fukumizu3

  • 1School of Nursing, College of Nursing and Nutrition, Shukutoku University, 673, Nitona-cho, Chuo-ku, Chiba, 260-8703, Japan. Masaharu.hayashi@soc.shukutoku.ac.jp.

Journal of Autism and Developmental Disorders
|June 28, 2021
PubMed

Insights

Melatonin effectively treats sleep problems in children with autism spectrum disorder (ASD). This study found that melatonin significantly reduced sleep onset latency in children with ASD compared to placebo.

Area of Science:

  • Pediatric Neurology
  • Sleep Medicine
  • Autism Spectrum Disorder Research

Background:

  • Melatonin is frequently used for sleep issues in children with autism spectrum disorder (ASD), but robust clinical evidence was lacking.
  • Sleep disturbances are common in children with ASD, impacting their quality of life and development.

Purpose of the Study:

  • To evaluate the efficacy of melatonin in treating sleep onset latency (SOL) in children with ASD.
  • To provide robust clinical evidence for melatonin use in this population.

Main Methods:

  • A phase 3, randomized, placebo-controlled clinical trial involving 196 children with ASD.
  • Participants received 1-mg melatonin, 4-mg melatonin, or placebo daily before bedtime, alongside sleep hygiene interventions.
  • Sleep onset latency was measured using electronic sleep diaries.

Main Results:

  • Both 1-mg and 4-mg melatonin doses significantly shortened sleep onset latency compared to placebo.
  • The mean SOL reduction was -22.0 minutes for 1-mg melatonin and -28.0 minutes for 4-mg melatonin (p < 0.0001).
  • Placebo group showed a mean SOL reduction of -5.0 minutes.

Conclusions:

  • Melatonin is a clinically reasonable and effective treatment for sleep onset difficulties in children with ASD.
  • This study provides strong evidence supporting the use of melatonin for managing sleep problems in pediatric ASD.
  • The findings support the integration of melatonin into clinical practice for children with ASD experiencing sleep disturbances.

Keywords:
Autism spectrum disorderMelatoninRandomized controlled trialSleep hygiene interventionsSleep problems

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