Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver’s Quality of Life

• Published in: Journal of autism and developmental disorders Vol. 49; no. 8; pp. 3218 - 3230
• Main Authors: Schroder, Carmen M., Malow, Beth A., Maras, Athanasios, Melmed, Raun D., Findling, Robert L., Breddy, John, Nir, Tali, Shahmoon, Shiri, Zisapel, Nava, Gringras, Paul
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.08.2019; Springer; Springer Nature B.V
• Subjects: Adolescents; Aggression; Analysis; Attention Deficit Hyperactivity Disorder; Autism; Autism Spectrum Disorders; Autistic children; Behavior; Behavior Modification; Behavior Problems; Behavioral Science and Psychology; Behavioral Sciences; Blindness; Care and treatment; Caregivers; Child and School Psychology; Child Behavior; Children; Departments; Double-blind studies; Drug Therapy; Efficacy; Externalizing behaviour; Genetic Disorders; Health aspects; Hygiene; Insomnia; Internalization; Melatonin; Neurology; Neurosciences; Original Paper; Parents; Pediatrics; Pervasive Developmental Disorders; Psychology; Public Health; Quality of Life; Questionnaires; Release; Safety and security measures; Sleep; Sleep disorders; Smith-Magenis syndrome; Tablets; Withdrawal (Psychology); Young Children; Autism; Children (pediatric); Sleep; Behavior; Prolonged-release melatonin
• ISSN: 0162-3257; 1573-3432; 1573-3432
• DOI: 10.1007/s10803-019-04046-5

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.