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

Beth Malow, Karen W. Adkins, Susan G. McGrew, Lily Wang, Suzanne E. Goldman, Diane Fawkes, Courtney Burnette

Research output: Contribution to journalArticlepeer-review

130 Scopus citations


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 doseescalation 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.

Original languageEnglish (US)
Pages (from-to)1729-1737
Number of pages9
JournalJournal of Autism and Developmental Disorders
Issue number8
StatePublished - Aug 2012
Externally publishedYes


  • Actigraphy
  • Autism diagnostic observation schedule
  • Child behavior checklist
  • Children's sleep habits questionnaire
  • Clinical trial
  • Insomnia
  • Melatonin

ASJC Scopus subject areas

  • Developmental and Educational Psychology


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