Melatonin for disordered sleep in individuals with autism spectrum disorders: systematic review and discussion

Sleep Med Rev. 2011 Dec;15(6):379-87. doi: 10.1016/j.smrv.2011.02.001. Epub 2011 Mar 9.


Sleep disturbance is common in autism spectrum disorders (ASD) and melatonin is widely prescribed in such cases despite a lack of guidelines. The aim of this paper is to provide a systematic review of efficacy and safety of exogenous melatonin for treating disordered sleep in individuals with ASD. We performed a Pubmed(®) documentary search enlarged by a manual review of references, which finally supplied 12 citations (4 case reports, 3 retrospective studies, 2 open-label clinical trials, and 3 placebo-controlled trials). As a whole, we found that the literature supports the existence of a beneficial effect of melatonin on sleep in individuals with ASD, with only few and minor side effects. However, considering the small number of studies and their methodological limits, these conclusions cannot yet be regarded as evidence-based. Randomized controlled trials and long-term follow-up data are still lacking to better assess efficacy and safety of exogenous melatonin for disordered sleep in individuals with ASD.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Adolescent
  • Adult
  • Central Nervous System Depressants / therapeutic use*
  • Child
  • Child Development Disorders, Pervasive / complications*
  • Humans
  • Melatonin / therapeutic use*
  • Sleep Wake Disorders / complications*
  • Sleep Wake Disorders / drug therapy
  • Young Adult


  • Central Nervous System Depressants
  • Melatonin