title: Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes.
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.
authors.affiliation: Sleep Disorders Division, Department of Neurology and Kennedy Center, Vanderbilt University School of Medicine, Nashville, TN 37232, USA. beth.malow@vanderbilt.edu
authors.forename: Beth
authors.initials: B
authors.lastname: Malow
authors.forename: Karen W
authors.initials: KW
authors.lastname: Adkins
authors.forename: Susan G
authors.initials: SG
authors.lastname: McGrew
authors.forename: Lily
authors.initials: L
authors.lastname: Wang
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Goldman
authors.forename: Diane
authors.initials: D
authors.lastname: Fawkes
authors.forename: Courtney
authors.initials: C
authors.lastname: Burnette
mesh_terms: D001321:Autistic Disorder / Q000150:complications*; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012890:Sleep / Q000187:drug effects*; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D002492:Central Nervous System Depressants; D008550:Melatonin