In view of a recent 3-month double-blind, placebo-controlled study reporting the efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for insomnia in children with autism spectrum disorder, researchers here examined how PedPRM treatment affect sleep, growth, body mass index, and pubertal development in long term. T
he double-blind, placebo-controlled trial was completed by 80 children and adolescents (2–17.5 years of age; 96% with autism spectrum disorder); these were administered 2 mg, 5 mg, or 10 mg PedPRM nightly up to 104 weeks, followed by a 2-week placebo period to assess withdrawal effects. During the 104-week treatment period, there remained improvements in child sleep disturbance and caregiver satisfaction with child sleep patterns, quality of sleep, and quality of life. The measures declined during the 2-week withdrawal placebo period compared with the treatment period but these were still improved compared with baseline.
Outcomes support the safety and efficacy of nightly PedPRM at optimal dose (2, 5, or 10 mg nightly) for long-term treatment in children and adolescents with autism spectrum disorder and insomnia. No detrimental effects were observed on children’s growth and pubertal development and there were no withdrawal or safety issues related to the use or discontinuation of the drug.