Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder.
autism
melatonin
sleep
Journal
Journal of the American Academy of Child and Adolescent Psychiatry
ISSN: 1527-5418
Titre abrégé: J Am Acad Child Adolesc Psychiatry
Pays: United States
ID NLM: 8704565
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
21
08
2019
revised:
17
12
2019
accepted:
16
01
2020
pubmed:
27
1
2020
medline:
20
4
2021
entrez:
27
1
2020
Statut:
ppublish
Résumé
A recent 3-month double-blind, placebo-controlled study demonstrated efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for insomnia in children with autism spectrum disorder. This study examined the long-term effects of PedPRM treatment on sleep, growth, body mass index, and pubertal development. Eighty children and adolescents (2-17.5 years of age; 96% with autism spectrum disorder) who completed the double-blind, placebo-controlled trial were given 2 mg, 5 mg, or 10 mg PedPRM nightly up to 104 weeks, followed by a 2-week placebo period to assess withdrawal effects. Improvements in child sleep disturbance and caregiver satisfaction with child sleep patterns, quality of sleep, and quality of life were maintained throughout the 104-week treatment period (p < .001 versus baseline for all). During the 2-week withdrawal placebo period, measures declined compared with the treatment period but were still improved compared with baseline. PedPRM was generally safe; the most frequent treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%). Changes in mean weight, height, body mass index, and pubertal status (Tanner staging done by a physician) were within normal ranges for age with no evidence of delay in body mass index or pubertal development. Nightly PedPRM at optimal dose (2, 5, or 10 mg nightly) is safe and effective for long-term treatment in children and adolescents with autism spectrum disorder and insomnia. There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug. Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; https://clinicaltrials.gov/; NCT01906866.
Identifiants
pubmed: 31982581
pii: S0890-8567(20)30034-4
doi: 10.1016/j.jaac.2019.12.007
pmc: PMC8084705
mid: NIHMS1691958
pii:
doi:
Substances chimiques
Melatonin
JL5DK93RCL
Banques de données
ClinicalTrials.gov
['NCT01906866']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
252-261.e3Subventions
Organisme : NCATS NIH HHS
ID : KL2 TR000446
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002243
Pays : United States
Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
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