Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
Autism
Behavior
Children (pediatric)
Prolonged-release melatonin
Sleep
Journal
Journal of autism and developmental disorders
ISSN: 1573-3432
Titre abrégé: J Autism Dev Disord
Pays: United States
ID NLM: 7904301
Informations de publication
Date de publication:
Aug 2019
Aug 2019
Historique:
pubmed:
13
5
2019
medline:
15
10
2019
entrez:
13
5
2019
Statut:
ppublish
Résumé
A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2-5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver's quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers' quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers' quality of life.
Identifiants
pubmed: 31079275
doi: 10.1007/s10803-019-04046-5
pii: 10.1007/s10803-019-04046-5
pmc: PMC6647439
doi:
Substances chimiques
Central Nervous System Depressants
0
Melatonin
JL5DK93RCL
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
3218-3230Subventions
Organisme : NICHD NIH HHS
ID : U54 HD083211
Pays : United States
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