Posted by Michael Wonder on 11 Sep 2025
Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith-Magenis syndrome
10 September 2025 - Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorisation for Slenyto, an extended-release melatonin mini tablet indicated for the treatment of insomnia in children and adolescents aged 2 to <18 years with autism spectrum disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
Slenyto has been evaluated in randomised, double-blind, placebo-controlled long-term trial involving children with autism spectrum disorder and/or Smith-Magenis syndrome.
