Neuroscience drug discovery and development company Neurim Pharmaceuticals announced on Wednesday that the European Commission has approved an extension of the indication for paediatric prolonged-release melatonin (Slenyto) to include the treatment of insomnia in children with attention deficit hyperactivity disorder (ADHD).

This followed a recommendation from 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 European Union 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.