| Autor: |
Schroder CM; Department of Child and Adolescent Psychiatry & Excellence Centre for Autism and Neurodevelopmental Disorders STRAS&ND, Strasbourg University Hospitals & University of Strasbourg Medical School, 67000 Strasbourg, France; CNRS UPR 3212, Institute for Cellular and Integrative Neurosciences; Sleep Disorders Center& International Research Center for ChronoSomnology, Strasbourg, France., Banaschewski T; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany., Fuentes J; Child and Adolescent Psychiatry Unit, Service of Child and Adolescent Psychiatry, Policlínica Gipuzkoa and GAUTENA Autism Society, San Sebastián, Spain., Hill CM; School of Clinical Experimental Sciences, Faculty of Medicine, University of Southampton, and Southampton Children's Hospital Department of Sleep Medicine, Southampton, UK., Hvolby A; Department of Child and Adolescent Psychiatry, Psychiatry in Region of South Denmark, Esbjerg, and Department of Regional Health Research, University of Southern Denmark, Odense, Denmark., Posserud MB; Department of Clinical Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway., Bruni O; Department of Developmental and Social Psychology, Sapienza University, Rome, Italy. |
| Abstrakt: |
Introduction : Insomnia is common among children and adolescents with Autism spectrum disorder (ASD). The first drug licensed for insomnia in this population, a pediatric-appropriate prolonged-release melatonin (PedPRM) formulation is described. Areas covered : Literature search on PedPRM efficacy and safety profile in clinical trials, and a proposed decision-making algorithm to optimize outcome in the treatment of insomnia in children and adolescents with ASD. Expert opinion : PedPRM treatment effectively improves sleep onset, duration and consolidation, and daytime externalizing behaviors in children and adolescents with ASD and subsequently caregivers' quality of life and satisfaction with their children's sleep. The coated, odorless and taste-free mini-tablets are well-accepted in this population who often have sensory hypersensitivity and problems swallowing standard tablet preparations. The most frequent long-term treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%) with no evidence of delay in height, BMI, or pubertal development, or withdrawal effects. The starting dose is 2 mg once daily independent of age or weight, escalated to 5-10 mg/day if predefined treatment success criteria are unmet. Slow melatonin metabolizers (~10% of children), may require lower doses. Given its long-term efficacy, safety and acceptance, PedPRM may ameliorate long-term consequences of insomnia in this population. |
