Newly Approved Pediatric Prolonged-Release Melatonin Shows Success for Treating ASD Related Insomnia

August 09, 2021

Benefits Include Increased Sleep Time, Reduced Sleep Latency, & Improved Sleep Continuity

Approximately half of the individuals with autism spectrum disorder (ASD), including children, experience sleep disorders. Adequate sleep plays a critical role in the neurological, psychological, and physical development of children and adolescents. Sleep deficits have been associated with hyperactivity-impulsivity, poor cognitive performance, and difficulties with social development. Countless caregivers to children with autism have suffered through many sleepless nights. It is for these reasons that parents in Europe have a reason to celebrate. According to a new study published in Expert Opinion on Pharmacotherapy, a new pharmacological treatment called PedPRM from Slenyton Neurim Pharmaceuticals has been shown to effectively improve sleep onset, duration, and consolidation for children with ASD. Even more encouraging is that these prolonged-release melatonin mini tablets are coated, odorless and taste-free, making the medication easy for children to take.  Most importantly, they were shown to be effective and safe for even long-term usage (over 24 months). For children who were not helped by sleep hygiene interventions, the recommended dose is 2 mg per day, which can be escalated to 5-10 mg per day. PedPRM is the first drug licensed for insomnia in Europe to treat kids with autism. Unfortunately, it is not yet available in the United States. 

Original Study

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