Neurim Pharmaceuticals Receives European Approval for Pediatric Melatonin to Treat Insomnia in ADHD Children

Neurim Pharmaceuticals Secures European Market Authorization for Slentyto®



Neurim Pharmaceuticals has announced a significant milestone in pediatric healthcare following the European Commission's approval of Slentyto®, a prolonged-release melatonin medication designed specifically for children experiencing insomnia, particularly those diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). This pivotal decision follows the recommendation of the Committee for Medicinal Products for Human Use (CHMP) from the European Medicines Agency (EMA) earlier in January 2025.

Slentyto® is noteworthy not only for its innovative formulation but also for its targeted application. Initially approved in the EU in 2018 for children on the autism spectrum and those with Smith-Magenis Syndrome, its indication has gradually broadened to encompass children who have neurogenetic disorders. The latest approval allows it to be prescribed for children with ADHD, an area sorely in need of effective treatments, as studies indicate that insomnia significantly affects around 70% of ADHD-affected children. This troubling statistic highlights that such sleep disturbances can often begin early in life, frequently before a formal ADHD diagnosis is established.

Understanding the Link Between ADHD and Sleep Disorders



The intersection of ADHD and sleep disorders is increasingly recognized by both parents and healthcare providers. When children suffer from ADHD, their sleep duration and night awakenings can drastically differ from those of their typically developing peers. Sleep issues in these children are not just an inconvenience; they can exacerbate core ADHD symptoms and lead to increased daytime sleepiness, ultimately impairing their quality of life.

Current guidelines advocate for behavioral interventions to be the first line of treatment for insomnia in children affected by ADHD. However, behavioral methods alone may not suffice, particularly in severe cases. This is where Slentyto® becomes essential—a pharmaceutical solution that complements behavioral strategies, ensuring that children receive comprehensive care designed to improve both sleep quality and overall wellbeing.

Neurim Pharmaceuticals: A Commitment to Neuroscience Innovations



Neurim Pharmaceuticals, based in Israel, is dedicated to discovering and developing innovative treatments within the neuroscience sector. Their first product, CIRCADIN®, which helps patients over 55 manage insomnia, is currently available in 45 countries, solidifying Neurim's reputation as a forerunner in psychiatric and neurological drug development.

The company continues to build on its robust pipeline of products aimed at addressing central nervous system disorders, ensuring that both children and adult patients alike have access to effective treatment options.

In Conclusion



Neurim's approval for Slentyto® marks a critical advancement in addressing the complex needs of children facing insomnia related to ADHD. The proactive approach in leveraging both behavioral and pharmacological strategies ensures that these young patients receive the support they require, paving the way for improved quality of life and better sleep outcomes. If you want to know more about Neurim Pharmaceuticals and their pioneering products, visit Neurim.

Topics Health)

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