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Neurim Pharmaceuticals Secures European Approval for Slenyto®

On March 26, 2025, Neurim Pharmaceuticals announced that the European Commission has approved the expansion of the indication for Slenyto®, a prolonged-release melatonin formulation, to include the treatment of insomnia in children aged 6 to 17 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). This significant decision follows the recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025.

Slenyto® is already known for its efficiency in treating insomnia in children with autism spectrum disorders (ASD) and those with Smith-Magenis syndrome. Initially approved in the EU in 2018, its indication was broadened in 2024 to include specific neurogenetic disorders. With this recent development, it becomes the only authorized medication for addressing insomnia in these pediatric populations.

The newly adopted statement for Slenyto® is:
"Slenyto® is indicated for treating insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder (ASD) and/or neurogenetic disorders leading to nighttime awakenings, where sleep hygiene measures have been inadequate. It’s also indicated for children and adolescents aged 6 to 17 years with ADHD who face similar sleep difficulties."

Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals, acknowledged the pressing need for effective solutions for sleep disturbances among children with ADHD, noting, “The approval for Slenyto® by the European Commission is an important step toward meeting this significant therapeutic demand.”

Furthermore, experts Prof. Carmen Schroder and Prof. Oliviero Bruni highlighted the unique aspects of Slenyto®, emphasizing its prolonged-release melatonin formulation that mimics natural melatonin production and benefits children with developmental neurologic disorders, particularly enhancing both sleep initiation and maintenance.

The prevalence of sleep disorders is a notable comorbidity in ADHD, with studies revealing that up to 70% of affected children encounter sleep-related issues early on, often before the formal diagnosis of ADHD. These insomnia problems can exacerbate daytime sleepiness and negatively impact the quality of life for both young patients and their caregivers.

Current treatment strategies typically involve behavioral interventions led by parents as the primary approach for pediatric insomnia related to ADHD. However, Slenyto® serves as a unique pharmacological option that addresses not just sleep onset but also sleep maintenance, thereby enhancing overall sleep duration.

Understanding Slenyto®

Slenyto®’s innovative mini-tablet formulation is specifically designed for pediatric populations, ensuring easy swallowing, which is a common challenge in children diagnosed with ASD, Smith-Magenis syndrome, and ADHD. The prolonged release of melatonin throughout the night is intended to replicate the body’s natural melatonin secretion pattern, validated by a Phase III study demonstrating improvements in sleep latency, continuity, and total sleep duration among participants with and without comorbid ADHD.

The mechanism through which Slenyto® influences sleep latency and maintenance transcends the underlying disorder, offering potential benefits for all pediatric patients with sleep patterns disrupted due to atypical melatonin secretion. Thus, Slenyto® is positioned as a critical treatment for children struggling with sleep issues arising from neurodevelopmental disorders.

About Neurim Pharmaceuticals

Founded in Israel, Neurim Pharmaceuticals Ltd. focuses on drug development within the realm of neuroscience. Its flagship product, CIRCADIN®, is well-established for treating insomnia in adults over the age of 55 and is available in over 45 countries worldwide. The company holds a robust portfolio of innovative products aimed at tackling disorders of the central nervous system.

Neurim's commitment to addressing unmet medical needs, especially in the pediatric population struggling with sleep issues, showcases its leadership in advancing therapeutic options for vulnerable groups. For further inquiries, reach out to Guy Manor, VP of Business Operations, at info@neurim.com.