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Neurim Pharmaceuticals Secures European Marketing Authorization for Slenyto®

In a significant move to address sleep issues among children with Attention Deficit Hyperactivity Disorder (ADHD), Neurim Pharmaceuticals has announced that the European Commission has granted marketing authorization for Slenyto®, a prolonged-release melatonin formulation. This decision follows the recommendation made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025.

Slenyto® is a unique medication specifically tailored for children experiencing insomnia, particularly in light of its previous approvals for use in those with Autism Spectrum Disorder (ASD) and neurogenetic disorders. Initially approved in 2018, Slenyto®'s versatility has now broadened to include children and adolescents aged 6 to 17 who face sleep challenges linked to ADHD. Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals, remarked on the significance of this approval, acknowledging the high demand for effective treatments that can assist children struggling with sleep maintenance and duration.

This announcement aligns with current understanding of ADHD, where sleep disturbances are a common challenge, often affecting around 70% of children within this demographic. Notably, these sleep problems can commence even before a formal diagnosis of ADHD, leading to exacerbated core symptoms and reduced quality of life not just for the affected child, but also for their caregivers.

The Impact of Sleep on ADHD

Children with ADHD frequently encounter issues related to sleep initiation and maintenance. Traditional recommendations suggest behavioral interventions as the first line of treatment for pediatric insomnia, yet many families find these measures insufficient. With Slenyto®, Neurim offers a pharmacological alternative that can directly target the root causes of insomnia.

Slenyto® functions by mimicking the natural release of melatonin in the body, ensuring children receive new doses throughout the night. This mechanism is beneficial for those who naturally do not produce enough melatonin. The innovative formulation of Slenyto® also addresses the challenge of administering medication to pediatric populations, specifically designed for easy consumption to ensure compliance among young patients.

Clinical trials have shown that Slenyto® not only improves sleep latency and continuity but also enhances the overall sleep duration for children with neurodevelopmental disorders, including ADHD. The positive results observed in studies suggest that by improving sleep, Slenyto® could indirectly lead to better behavior and quality of life for both children and their families.

Expectation and Future Outlook

As the discourse around children's mental health and well-being continues to grow, the introduction of Slenyto® into the market is expected to provide a solution to many families grappling with ADHD-related sleep issues. Experts in the field, including Prof. Carmen Schroder and Prof. Oliviero Bruni, have highlighted the need for such specialized treatments that recognize the interconnection between sleep and behavioral health.

Neurim Pharmaceuticals remains committed to its mission of developing innovative solutions for CNS disorders, and Slenyto® marks a pivotal advancement in their product pipeline. For parents and caregivers of children with ADHD, Slenyto® represents hope in a landscape where the need for effective treatment options is more pressing than ever. As pediatric sleep health comes to the forefront of discussions, Slenyto® is poised to play a crucial role in reshaping how insomnia in children with ADHD is managed.