Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes
Open accessAbstract
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.
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Melatonin has been shown to reduce sleep latency.
“Melatonin has been shown to reduce sleep latency (the amount of time it takes to fall asleep) [61].”
From Pharmacological treatment in autism: a proposal for guidelines on common co-occurring psychiatric symptoms (2025) · cites this paper as [61]
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References 44 · Cited by 274
Research works printed but not linked: 27
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- Authors
- Malow, B., Adkins, K. W., McGrew, S. G., Wang, L., Goldman, S. E., Fawkes, D., & Burnette, C.
- Affiliations
- Vanderbilt University (US)
- Monroe Carell Jr. Children's Hospital (US)
- Corresponding author
- Malow, Beth
- Venue
- Journal of Autism and Developmental Disorders
- Published
- 2011-12-10
- Volume
- 42
- Issue
- 8
- Pages
- 1729-1737
- ISSN
- 0162-3257 (ISSN-L)
- 1573-3432
- PMC
- PMC3368078
- OpenAlex
- W2016511819
- Cited by
- 274
- References
- 44
- Citations by year
- 2026: 8 · 2025: 16 · 2024: 11 · 2023: 18 · 2022: 27 · 2021: 20 · 2020: 22 · 2019: 22 · 2018: 17 · 2017: 21 · 2016: 22 · 2015: 26 · 2014: 18 · 2013: 17 · 2012: 9
- FWCI
- 18.14
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Journal of Autism and Developmental Disorders (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Autism Speaks (AS1700)
- Vanderbilt University
- Vanderbilt Kennedy Center, Vanderbilt University Medical Center
- National Institute of Neurological Disorders and Stroke (U10NS077318)
- National Center for Research Resources (M01RR000095, M01-RR-00095)
- NIH Clinical Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (P30HD015052, HD 15052, R01HD059253, R01HD59253)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Keywords
- melatonin, autism spectrum disorder, sleep onset insomnia, children, dose-response relationship, tolerability, actigraphy, sleep latency, parental stress, behavioral effects
- MeSH terms
- Autistic Disorder, Central Nervous System Depressants, Child, Child, Preschool, Female, Humans, Male, Melatonin, Sleep, Sleep Wake Disorders, Treatment Outcome
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