Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Jun;52(6):2784-2793.
doi: 10.1007/s10803-021-05139-w. Epub 2021 Jun 28.

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

Masaharu Hayashi #  1 , Kazuo Mishima #  2 , Michio Fukumizu  3 , Hiroyuki Takahashi  4 , Yuko Ishikawa  5 , Izumi Hamada  5 , Hideyuki Sugioka  5 , Osamu Yotsuya  5 , Yushiro Yamashita  6
Affiliations
Clinical Trial

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

Masaharu Hayashi et al. J Autism Dev Disord. 2022 Jun.

Abstract

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.

Keywords: Autism spectrum disorder; Melatonin; Randomized controlled trial; Sleep hygiene interventions; Sleep problems.

PubMed Disclaimer

References

    1. Abdelgadir, I. S., Gordon, M. A., & Akobeng, A. K. (2018). Melatonin for the management of sleep problems in children with neurodevelopmental disorders: A systematic review and meta-analysis. Archives of Disease in Childhood, 103(12), 1155–1162. https://doi.org/10.1136/archdischild-2017-314181 - DOI - PubMed
    1. Abel, E., Kim, S. Y., Kellerman, A. M., & Brodhead, M. T. (2017). Recommendations for identifying sleep problems and treatment resources for children with autism spectrum disorder. Behavior Analysis in Practice, 10(3), 261–269. https://doi.org/10.1007/s40617-016-0158-4 - DOI - PubMed
    1. Aman, M. G., & Singh, N. (1994). Aberrant behavior checklist—community. Slosson Educational Publishing Inc.
    1. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Association.
    1. Astill, R. G., Van der Heijden, K. B., Van Ijzendoorn, M. H., & Van Someren, E. J. (2012). Sleep, cognition, and behavioral problems in school-age children: A century of research meta-analyzed. Psychological Bulletin, 138(6), 1109–1138. https://doi.org/10.1037/a0028204 - DOI - PubMed

Publication types