Neurim Pharmaceuticals Gains EU Approval for Pediatric Melatonin (Slenyto®) in ADHD-Related Insomnia

Neurim Pharmaceuticals, based in Tel Aviv, Israel, recently announced a significant development with the European Commission's approval to extend the use of their medication, Slenyto®. This decision marks an important step in addressing insomnia in children diagnosed with attention deficit hyperactivity disorder (ADHD). The approval followed a recommendation made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency back in January 2025.

Slenyto® is a prolonged-release melatonin formulation designed specifically for children. Initially, it gained approval in the European Union in 2018 for treating insomnia in children suffering from autism spectrum disorder (ASD) and Smith-Magenis Syndrome. In 2024, its use was broadened to include neurogenetic disorders (NGDs). Slenyto® remains the only authorized medication for managing insomnia associated with these conditions.

The newly expanded indication specifies that Slenyto® can be used for insomnia treatment in children and adolescents aged 2-18 who have ASD or neurogenetic disorders, characterized by irregular melatonin secretion or frequent nighttime awakenings when traditional sleep hygiene measures prove inadequate. Additionally, it is now approved for children and adolescents aged 6-17 with ADHD facing similar sleep challenges.

Professor Nava Zisapel, the CEO of Neurim Pharmaceuticals, emphasized the significant unmet need for addressing sleep disorders in children with ADHD. The European Commission's approval of Slenyto® for this population aims to fulfill that demand. ADHD often coexists with sleep disturbances, affecting up to 70% of children diagnosed with the disorder. These sleep issues can manifest early, sometimes even before an official ADHD diagnosis, and have been linked to more severe ADHD symptoms, increased daytime sleepiness, and diminished quality of life for both the children and their caregivers.

Traditional treatment approaches often suggest parent-driven behavioral interventions as the first line of defense against pediatric insomnia in ADHD. However, Slenyto® offers a unique pharmacological solution, targeting not only challenges with initiating sleep but also maintaining and extending sleep duration.

Slenyto® is a carefully formulated, age-appropriate melatonin-based tablet that caters to children with ASD, NGD, and ADHD. Its innovative design ensures ease of swallowing, which is particularly beneficial in pediatric populations. By delivering melatonin throughout the night, it simulates the natural melatonin release patterns seen in healthy individuals. Clinical studies, including a Phase III trial involving children and adolescents with ASD and SMS, indicate that Slenyto® improves sleep latency, continuity, and total nighttime duration. These improvements in sleep have been associated with better behavior, enhancing the well-being of both children and their parents.

The therapeutic effects of Slenyto® on sleep initiation, maintenance, and total sleep time are consistent across various neurodevelopmental disorders, regardless of the background condition. This makes Slenyto® a versatile option for managing sleep disturbances in patients whose conditions involve abnormal melatonin secretion patterns.

Neurim Pharmaceuticals continues to focus on neuroscience drug discovery and development. Their first approved product, CIRCADIN®, targets insomnia in patients over 55 and is available in 45 countries. With a strong pipeline of innovative products, Neurim remains committed to addressing central nervous system disorders.