melatonin (Neurim Pharmaceuticals)

Slenyto is a prolonged-release mini-tablet formulation of melatonin developed by Neurim Pharmaceuticals specifically for pediatric use. It is indicated for the treatment of insomnia in children and adolescents (ages 2-18) with Autism Spectrum Disorder (ASD) and Smith-Magenis Syndrome (SMS), where sleep hygiene measures have been insufficient. Unlike immediate-release melatonin, Slenyto's prolonged-release profile mimics the natural nocturnal secretion of melatonin, helping to maintain sleep throughout the night. It acts as an agonist at melatonin MT1 and MT2 receptors in the suprachiasmatic nucleus of the hypothalamus, which regulates the circadian rhythm and sleep-wake cycle. Slenyto was the first melatonin-based medication to receive European Commission approval specifically for pediatric neurodevelopmental disorders.

Brand names

Slenyto

Other names

prolonged-release melatoninpediatric prolonged-release melatonin