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

J Autism Dev Disord. 2012 Aug;42(8):1729-37; author reply 1738. doi: 10.1007/s10803-011-1418-3.

Abstract

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.

Publication types

  • Controlled Clinical Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Autistic Disorder / complications*
  • Central Nervous System Depressants / administration & dosage
  • Central Nervous System Depressants / adverse effects
  • Central Nervous System Depressants / therapeutic use*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Male
  • Melatonin / administration & dosage
  • Melatonin / adverse effects
  • Melatonin / therapeutic use*
  • Sleep / drug effects*
  • Sleep Wake Disorders / complications
  • Sleep Wake Disorders / drug therapy*
  • Treatment Outcome

Substances

  • Central Nervous System Depressants
  • Melatonin