Slenyto Approved for ADHD Insomnia
Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include the treatment of insomnia in children with attention deficit hyperactivity disorder (ADHD)
The European Commission decision followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025.
Slenyto is a child-appropriate prolonged release melatonin formulation that was first approved in the EU in 2018 for the treatment of insomnia in children with autism spectrum disorder (ASD) and/ or Smith-Magenis Syndrome. In 2024, the indication was extended to neurogenetic disorders (NGDs). Slenyto is the only authorised medication for insomnia in these disorders.
The adopted wording for the newly extended indication is:
"Slenyto is indicated for the treatment of insomnia:
- In children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient
- In children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient
"We recognise there is significant unmet need and high demand for addressing sleep maintenance and duration as well as sleep initiation difficulties of children with ADHD, who suffer from impaired sleep. The European Commission (EC) granted marketing authorization (MA) of Slenyto for insomnia in children with ADHD is a major move to satisfy this need." says Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals.
Prof. Carmen Schroder, MD, PhD, France, and Prof. Oliviero Bruni, MD, PhD, Italy, comment: " Slenyto® is a prolonged-release formulation of melatonin that delivers melatonin over the course of the night, mimicking the endogenous release profile in healthy subjects. Therefore, Slenyto® has the potential to treat the pathophysiology of insomnia in the population of children with neurodevelopmental disorders, among which ADHD, improving sleep latency, sleep continuity and total nighttime sleep duration, in particular in those who do not produce sufficient endogenous melatonin. Slenyto® has been specifically formulated for use in children and has a favorable safety profile. Subsequent improvements in child behavior (mainly due to longer uninterrupted sleep), parent satisfaction and quality of life (mainly affected by the child's behavior) are expected. The treatment will address a significant need in the medical management of many children and adolescents with ADHD".
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