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
. 2023 Oct 27;17(1):123.
doi: 10.1186/s13034-023-00669-w.

Adherence to treatment and parents' perspective about effectiveness of melatonin in children with autism spectrum disorder and sleep disturbances

Hadar Sadeh  1   2 , Gal Meiri  1   2 , Dikla Zigdon  1   2 , Michal Ilan  2 , Michal Faroy  1   2 , Analya Michaelovski  2   3 , Yair Sadaka  2   4 , Ilan Dinstein  2   5 , Idan Menashe  6   7
Affiliations

Adherence to treatment and parents' perspective about effectiveness of melatonin in children with autism spectrum disorder and sleep disturbances

Hadar Sadeh et al. Child Adolesc Psychiatry Ment Health. .

Abstract

Objective: Melatonin is considered an effective pharmacological treatment for the sleep disturbances that are reported in > 50% of children with autism spectrum disorder (ASD). However, real-life data about the long-term course and effectiveness of melatonin treatment in children with ASD is lacking.

Methods: In this retrospective cohort study, we assessed the adherence to melatonin treatment and parents' perspective of its effect on sleep quality and daytime behavior in children with ASD via a parental phone survey of children in the Azrieli National Center for Autism and Neurodevelopment Research (ANCAN) database. Cox regression analysis was used to assess the effect of key demographic and clinical characteristics on treatment adherence.

Results: Melatonin was recommended for ~ 8% of children in the ANCAN database. These children were characterized by more severe symptoms of autism. The median adherence time for melatonin treatment exceeded 88 months, with the most common reason for discontinuation being a lack of effectiveness (14%). Mild side-effects were reported in 14% of children, and 86%, 54%, and 45% experienced improvements in sleep onset, sleep duration and night awakenings, respectively. Notably, melatonin also improved the daytime behaviors of > 28% of the children. Adherence to treatment was independently associated with improvements in night awakenings and educational functioning (aHR = 0.142, 95%CI = 0.036-0.565; and aHR = 0.195, 95%CI = 0.047-0.806, respectively).

Conclusions: Based on parents' report, melatonin is a safe and effective treatment that improves both sleep difficulties and daily behavior of children with ASD.

Keywords: Autism spectrum disorder; Drug effectiveness; Insomnia; Sleep.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests. Gal Meiri, Ilan Dinstein and Idan Menashe are members of the steering committee of ANCAN that previously received research funding from Neurim Pharmaceuticals.

Figures

Fig. 1
Fig. 1
Kaplan-Meier Curve of Melatonin Treatment Adherence over Time. The cumulative adherence probability to melatonin treatment over time is depicted by a continuous black line with 95% confidence intervals in black dashed lines
Fig. 2
Fig. 2
Effect of Melatonin on Sleep and Daytime Behaviors of Children with ASD. (A) & (B) Rates of children whose parents reported an effect of melatonin treatment on their sleep parameters (A) and daytime behaviors (B). (C) Kohen’s kappa coefficients for the concordance between different effects of melatonin treatment
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Sivertsen B, Gillberg C, Hysing M. Sleep problems in children with autism spectrum problems : a longitudinal population-based study. Published Online. 2012 doi: 10.1177/1362361311404255. - DOI - PubMed
    1. Chen H, Yang T, Chen J, et al. Sleep problems in children with autism spectrum disorder: a multicenter survey. BMC Psychiatry. 2021;21(1). 10.1186/s12888-021-03405-w. - PMC - PubMed
    1. Cortese S, Wang F, Angriman M, Masi G, Bruni O. Sleep disorders in Children and adolescents with Autism Spectrum Disorder: diagnosis, epidemiology, and management. CNS Drugs. 2020;34(4):415–23. doi: 10.1007/s40263-020-00710-y. - DOI - PubMed
    1. Johnson KP, Zarrinnegar P. Autism spectrum disorder and sleep. Child Adolesc Psychiatr Clin N Am. 2021;30(1):195–208. doi: 10.1016/j.chc.2020.08.012. - DOI - PubMed
    1. Williams PG, Sears LL, Allard A. Sleep problems in children with autism. J Sleep Res Published Online. 2004 doi: 10.1111/j.1365-2869.2004.00405.x. - DOI - PubMed

LinkOut - more resources