3 years ago

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

To assess the efficacy and safety of novel pediatric-appropriate prolonged-release melatonin minitablets (PedPRM) vs. placebo for insomnia in children with autism spectrum disorder (ASD), with or without attention-deficit/hyperactivity disorder (ADHD) comorbidity, and neurogenetic disorders (NGD). Method 125 children (2-17.5 years; 96.8% ASD, 3.2% Smith-Magenis syndrome [SMS]) whose sleep failed to improve on behavioral intervention alone were randomized (1:1 ratio), double-blind, to receive PedPRM (2mg escalated to 5mg) or placebo for 13 weeks. Sleep measures included the validated caregivers’ Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI). The a priori primary endpoint was SND-reported total sleep time (TST) after 13 weeks of treatment. Results The study met the primary endpoint: after 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with PedPRM compared to 9.14 with placebo (adjusted mean treatment difference PedPRM–placebo -32.43 minutes; p=.034). Sleep latency (SL) decreased by 39.6 minutes on average with PedPRM and 12.5 with placebo (adjusted mean treatment difference -25.30 minutes; p=.011) without causing earlier wakeup time. Rate of participants attaining clinically meaningful responses in TST and/or SL was significantly higher with PedPRM than placebo (68.9% vs 39.3% respectively; p=.001) corresponding to number needed to treat (NNT) 3.38. Overall sleep disturbance (CSDI) tended to decrease. PedPRM was generally safe; somnolence was more commonly reported with PedPRM than placebo. Conclusion PedPRM was efficacious and safe for treatment of insomnia in children with ASD with/without ADHD and NGD. The acceptability of this pediatric formulation in a population who usually experience significant difficulties in swallowing was remarkably high.

Publisher URL: www.sciencedirect.com/science

DOI: S0890856717316726

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