Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder
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Objective: A recent double-blind randomized placebo-controlled study demonstrated 3-month efficacy and safety of a novel pediatric-appropriate prolonged-release melatonin (PedPRM) for insomnia in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity. Long-term efficacy and safety of PedPRM treatment was studied. Methods: A prospective, open-label efficacy and safety follow-up of nightly 2, 5, or 10 mg PedPRM in subjects who completed the 13-week double-blind trial (51 PedPRM; 44 placebo). Measures included caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index). Results: Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2–17.5 years) received PedPRM (2/5 mg) according to the double-blind phase dose, for 39 weeks with optional dose adjustment (2, 5, or 10 mg/day) after the first 13 weeks. After 52 weeks of continuous treatment (PedPRM-randomized group) subjects slept (mean [SE]) 62.08 (21.5) minutes longer ( p = 0.007); fell asleep 48.6 (10.2) minutes faster ( p < 0.001); had 89.1 (25.5) minutes longer uninterrupted sleep episodes ( p = 0.001); 0.41 (0.12) less nightly awakenings (>50% decrease; p = 0.001); and better sleep quality ( p < 0.001) compared with baseline. The placebo-randomized group also improved with PedPRM. Altogether, by the end of 39-week follow-up, regardless of randomization assignment, 55/72 (76%) of completers achieved overall improvement of ≥1 hour in total sleep time (TST), sleep latency or both, over baseline, with no evidence of decreased efficacy. In parallel, CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns ( p < 0.001 for both), PSQI global ( p < 0.001), and WHO-5 ( p = 0.001) improved in statistically significant and clinically relevant manner ( n = 72) compared with baseline. PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients). Conclusion: PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.
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PedPRM has been shown to be efficacious and safe for the long-term treatment of insomnia in children with ASD in initial research.
“PedPRM has been shown to be efficacious and safe for the long-term treatment of insomnia in children with ASD in initial research [63].”
From Pharmacological treatment in autism: a proposal for guidelines on common co-occurring psychiatric symptoms (2025) · cites this paper as [63]
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- Authors
- Maras, A., Schroder, C. M., Malow, B. A., Findling, R. L., Breddy, J., Nir, T., Shahmoon, S., Zisapel, N., & Gringras, P.
- Affiliations
- Yulius (NL)
- Centre National de la Recherche Scientifique (FR)
- Vanderbilt University Medical Center (US)
- Kennedy Krieger Institute (US)
- Pharmastat Consulting Ltd.
- Neurim Pharmaceuticals (Israel) (IL)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- Corresponding author
- Maras, Athanasios
- ORCID
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2018-12
- Volume
- 28
- Issue
- 10
- Pages
- 699-710
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- PMC
- PMC6306655
- OpenAlex
- W2888600704
- Cited by
- 176
- References
- 44
- Citations by year
- 2026: 15 · 2025: 28 · 2024: 26 · 2023: 23 · 2022: 25 · 2021: 15 · 2020: 28 · 2019: 13 · 2018: 3
- FWCI
- 19.32
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- BiblioBoard Library Catalog (Open Research Library) (submittedVersion, cc-by-nc-nd)
- INSAR 2018 Annual Meeting
- Funders
- Children's Hospital of Philadelphia
- University Hospital Southampton NHS Foundation Trust
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54HD083211)
- 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
- prolonged-release melatonin, pediatric insomnia, autism spectrum disorder, neurogenetic disorders, ADHD comorbidity, long-term efficacy, sleep quality, sleep latency, total sleep time, sleep disorders, quality of life, children and adolescents, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index
- MeSH terms
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Central Nervous System Depressants, Child, Communication Disorders, Delayed-Action Preparations, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Sleep Initiation and Maintenance Disorders, Male, Melatonin, Quality of Life, Comorbidity, Treatment Outcome, Drug Monitoring, Polysomnography
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