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

J Autism Dev Disord. 2022 Jun;52(6):2784-2793. doi: 10.1007/s10803-021-05139-w. Epub 2021 Jun 28.


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.

Keywords: Autism spectrum disorder; Melatonin; Randomized controlled trial; Sleep hygiene interventions; Sleep problems.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Autism Spectrum Disorder* / drug therapy
  • Child
  • Humans
  • Melatonin*
  • Sleep
  • Sleep Hygiene
  • Sleep Wake Disorders* / drug therapy


  • Melatonin