An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism

J Autism Dev Disord. 2006 Aug;36(6):741-52. doi: 10.1007/s10803-006-0116-z.


Long-term effectiveness of controlled-release melatonin in 25 children, aged 2.6-9.6 years with autism without other coexistent pathologies was evaluated openly. Sleep patterns were studied using Children's Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, after 1-3-6 months melatonin treatment and 1 month after discontinuation. Sleep diary and CSHQ showed a more problematic sleep in autistic children compared with controls. During treatment sleep patterns of all children improved. After discontinuation 16 children returned to pre-treatment score, readministration of melatonin was again effective. Treatment gains were maintained at 12 and 24-month follow-ups. No adverse side effects were reported. In conclusion, controlled-release melatonin may provide an effective and well-tolerated treatment for autistic children with chronic sleep disorders.

MeSH terms

  • Administration, Oral
  • Autistic Disorder / diagnosis
  • Autistic Disorder / drug therapy*
  • Autistic Disorder / epidemiology
  • Child
  • Child, Preschool
  • Comorbidity
  • Cross-Sectional Studies
  • Delayed-Action Preparations
  • Female
  • Follow-Up Studies
  • Humans
  • Italy
  • Long-Term Care
  • Male
  • Melatonin / administration & dosage*
  • Sleep Wake Disorders / diagnosis
  • Sleep Wake Disorders / drug therapy*
  • Sleep Wake Disorders / epidemiology
  • Treatment Outcome


  • Delayed-Action Preparations
  • Melatonin