Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial

Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or pl...

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Published inJournal of autism and developmental disorders Vol. 52; no. 6; pp. 2784 - 2793
Main Authors Hayashi, Masaharu, Mishima, Kazuo, Fukumizu, Michio, Takahashi, Hiroyuki, Ishikawa, Yuko, Hamada, Izumi, Sugioka, Hideyuki, Yotsuya, Osamu, Yamashita, Yushiro
Format Journal Article
LanguageEnglish
Published New York Springer US 01.06.2022
Springer
Springer Nature B.V
Subjects
Adequacy
Autism
Autism Spectrum Disorder - drug therapy
Autistic children
Behavioral Science and Psychology
Child
Child and School Psychology
Children
Clinical research
Clinical trials
Complications and side effects
Dosage and administration
Drug Therapy
Humans
Hygiene
Intervention
Latency
Melatonin
Neurosciences
Original Paper
Pediatric research
Pediatrics
Pervasive Developmental Disorders
Placebos
Program Effectiveness
Psychology
Public Health
Risk factors
Sleep
Sleep disorders
Sleep Hygiene
Sleep Wake Disorders - drug therapy
Japan
Melatonin
Sleep hygiene interventions
Randomized controlled trial
Autism spectrum disorder
Sleep problems
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Summary:Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (− 22.0, − 28.0, and − 5.0 min, respectively; p  < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD.
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ISSN:0162-3257
1573-3432
DOI:10.1007/s10803-021-05139-w