Original paper

Journal of Autism and Developmental Disorders

, Volume 42, Issue 8, pp 1729-1737

Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes

  • Beth MalowAffiliated withSleep Disorders Division, Department of Neurology and Kennedy Center, Vanderbilt University School of Medicine Email author 
  • , Karen W. AdkinsAffiliated withSleep Disorders Division, Department of Neurology, Vanderbilt University School of Medicine
  • , Susan G. McGrewAffiliated withDepartment of Pediatrics, Monroe Carell Children’s Hospital at Vanderbilt
  • , Lily WangAffiliated withDepartment of Biostatistics, Vanderbilt University School of Medicine
  • , Suzanne E. GoldmanAffiliated withSleep Disorders Division, Department of Neurology and Kennedy Center, Vanderbilt University School of Medicine
  • , Diane FawkesAffiliated withSleep Disorders Division, Department of Neurology and Kennedy Center, Vanderbilt University School of Medicine
  • , Courtney BurnetteAffiliated withDepartment of Pediatrics, Monroe Carell Children’s Hospital at Vanderbilt

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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.

Keywords

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