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

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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: Gringras, Paul
Breddy, John
Findling, Robert L.
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: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
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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Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder

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