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Investigators from multiple institutions conducted a study assessing the long-term efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for treatment of insomnia in children 2–17 years old with autism spectrum disorder (ASD). Participants in this study had completed a 3-month randomized controlled trial (RCT) of PedPRM that was conducted at multiple sites in the US and Europe. For the current study, participants who had received PedPRM during the RCT continued on the medication and those who been randomized to placebo were switched to active treatment for an additional 91 weeks. Thus, study children who had been randomized to PedPRM received a total of 104 weeks of treatment, and those who received placebo in the RCT …
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