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

• Published in: Journal of child and adolescent psychopharmacology Vol. 28; no. 10; pp. 699 - 710
• Main Authors: Maras, Athanasios, Schroder, Carmen M., Malow, Beth A., Findling, Robert L., Breddy, John, Nir, Tali, Shahmoon, Shiri, Zisapel, Nava, Gringras, Paul
• Format: Journal Article
• Language: English
• Published: United States Mary Ann Liebert, Inc 01.12.2018; Mary Ann Liebert, Inc., publishers
• Subjects: Adolescents; Age; Attention Deficit Disorder with Hyperactivity - complications; Attention Deficit Disorder with Hyperactivity - epidemiology; Attention deficit hyperactivity disorder; Autism; Autism Spectrum Disorder - complications; Autism Spectrum Disorder - epidemiology; Autistic children; Behavior modification; Caregivers; Central Nervous System Depressants - administration & dosage; Central Nervous System Depressants - adverse effects; Child; Child & adolescent psychiatry; Children; Children & youth; Communication Disorders - complications; Communication Disorders - epidemiology; Comorbidity; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Dose-Response Relationship, Drug; Drug Monitoring; Families & family life; Fatigue; Female; Follow-Up Studies; Humans; Hyperactivity; Insomnia; Intervention; Latency; Male; Melatonin; Melatonin - administration & dosage; Melatonin - adverse effects; Mental health; Mood; Original; Parents & parenting; Pediatrics; Pharmaceuticals; Polysomnography - methods; Quality of Life; Regulatory approval; Safety; Sleep; Sleep and wakefulness; Sleep disorders; Sleep Initiation and Maintenance Disorders - diagnosis; Sleep Initiation and Maintenance Disorders - drug therapy; Sleep Initiation and Maintenance Disorders - etiology; Sleep Initiation and Maintenance Disorders - psychology; Statistical analysis; Teenagers; Treatment Outcome; Well being; United Kingdom > UK; France; Netherlands; sleep disorders; melatonin; autism; insomnia; long-term; pediatric

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 attentio...