CHMP recommends approval of Slentyo for treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome.- RAD Neurim Pharma.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Slenyto (melatonin prolonged-release), from RAD Neurim Pharmaceuticals, intended for the treatment of insomnia in children and adolescents with autism spectrum disorder (ASD) or Smith-Magenis syndrome.

Slenyto will be available as 1 -mg and 5- mg prolonged -release tablets. The active substance of Slenyto is melatonin, which promotes sleep by activation of melatonin receptors. The benefits with Slenyto are its ability to increase sleep duration. The most common side effects are somnolence, fatigue and mood swings. The full indication is: �Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. �