Slenyto® is the first and only pharmacotherapy that is approved for the treatment of insomnia in children with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS). Slenyto® is a prolonged-release melatonin minitablet developed specifically for the treatment of insomnia in these children, addressing their specific needs.
Slenyto® has been investigated in a robust pediatric investigational plan that included the pediatric minitablets development, non-clinical studies and several clinical studies including a Phase III clinical trial in 24 leading Pediatric ASD centers in USA and Europe.
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 (SMS), where sleep hygiene measures have been insufficient.
Slenyto® mechanism of action & pharmacokinetics
Melatonin has a very short half-life (40 minutes). Slenyto® is a prolonged-release melatonin formulation that uniquely mimics endogenous melatonin secretion, maintaining elevated melatonin levels throughout the night.
In the paediatric population comprising 16 ASD children ages 7-15 years old suffering from insomnia, following Slenyto® 2mg administration after a standardized breakfast, melatonin concentrations peaked within 2 hours after administration and remained elevated for 6 hours thereafter, confirming its “endogenous-like” melatonin secretion and supporting its clinical benefits. In contrast, Immediate-Release melatonin peaks after 2 hours and high doses or repeated administration are needed.