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Cited by 306Sleep and related disordersCircadian rhythm and melatoninAutism Spectrum Disorder Research

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder

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Gringras, Paul, Nir, Tali, Breddy, John, Frydman-Marom, Anat, Findling, Robert L.·2017·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1016/j.jaac.2017.09.414
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Abstract

OBJECTIVE: To assess the efficacy and safety of novel pediatric-appropriate, prolonged-release melatonin minitablets (PedPRM) versus placebo for insomnia in children and adolescents with autism spectrum disorder (ASD), with or without attention-deficit/hyperactivity disorder (ADHD) comorbidity, and neurogenetic disorders (NGD). METHOD: A total of 125 children and adolescents (2-17.5 years of age; 96.8% ASD, 3.2% Smith-Magenis syndrome [SMS]) whose sleep failed to improve on behavioral intervention alone were randomized (1:1 ratio), double-blind, to receive PedPRM (2 mg escalated to 5 mg) or placebo for 13 weeks. Sleep measures included the validated caregivers' Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI). The a priori primary endpoint was SND-reported total sleep time (TST) after 13 weeks of treatment. RESULTS: The study met the primary endpoint: after 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with PedPRM compared to 9.14 minutes with placebo (adjusted mean treatment difference PedPRM-placebo -32.43 minutes; p = .034). Sleep latency (SL) decreased by 39.6 minutes on average with PedPRM and 12.5 minutes with placebo (adjusted mean treatment difference -25.30 minutes; p = .011) without causing earlier wakeup time. The rate of participants attaining clinically meaningful responses in TST and/or SL was significantly higher with PedPRM than with placebo (68.9% versus 39.3% respectively; p = .001) corresponding to a number needed to treat (NNT) of 3.38. Overall sleep disturbance (CSDI) tended to decrease. PedPRM was generally safe; somnolence was more commonly reported with PedPRM than placebo. CONCLUSION: PedPRM was efficacious and safe for treatment of insomnia in children and adolescents with ASD with/without ADHD and NGD. The acceptability of this pediatric formulation in a population who usually experience significant difficulties in swallowing was remarkably high. Clinical trial registration information-Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; http://clinicaltrials.gov/; NCT01906866.

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Authors
Gringras, P., Nir, T., Breddy, J., Frydman-Marom, A., & Findling, R. L.
Affiliations
  • Guy's Hospital (GB)
  • Neurim Pharmaceuticals (Israel) (IL)
  • Kennedy Krieger Institute (US)
Corresponding author
Gringras, Paul
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2017-11
Volume
56
Issue
11
Pages
948-957.e4
ISSN
0890-8567 (ISSN-L)
DOI
10.1016/j.jaac.2017.09.414
OpenAlex
W2756112142
Cited by
306
References
28
Citations by year
2026: 21 · 2025: 48 · 2024: 41 · 2023: 31 · 2022: 50 · 2021: 31 · 2020: 42 · 2019: 25 · 2018: 16
FWCI
29.35
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
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, prolonged-release melatonin, pediatric insomnia, autism spectrum disorder, ADHD comorbidity, neurogenetic disorders, Smith-Magenis syndrome, sleep latency, total sleep time, sleep disorders, sleepiness, dysphagia, children and adolescents, treatment efficacy and safety, number needed to treat
MeSH terms
Autism Spectrum Disorder, Adolescent, Attention Deficit Disorder with Hyperactivity, Central Nervous System Depressants, Child, Child, Preschool, Delayed-Action Preparations, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Melatonin, Outcome Assessment, Health Care

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