A new prescription extended-release melatonin medication called Slenyto has now become available across Canada, offering a targeted treatment option for sleep problems in children and adolescents with autism spectrum disorder and Smith-Magenis syndrome.
A prescription melatonin treatment for children and teenagers with certain neurodevelopmental conditions is now available across Canada, giving families a new option for persistent sleep problems linked to autism spectrum disorder and Smith-Magenis syndrome.
The medicine, sold as Slenyto, is an extended-release melatonin mini-tablet that is intended to release the hormone gradually through the night. According to the company’s announcement and a notice from Newswire Canada, the tablet is designed to mimic the body’s natural melatonin pattern and comes as an odourless, tasteless 3 mm pill for paediatric use.
Health Canada granted marketing authorisation for the treatment on 8 September 2025, and Kye Pharmaceuticals said it is handling the Canadian rollout under a licensing and distribution agreement with Neurim Pharmaceuticals. The companies say the drug is approved for children and adolescents aged 2 to 18 who have insomnia associated with autism spectrum disorder, Smith-Magenis syndrome, or both.
The launch comes against a backdrop of substantial sleep disruption in these groups. The companies say insomnia affects between 50% and 80% of children with autism spectrum disorder or Smith-Magenis syndrome, far above rates seen in typically developing children. Health Canada has also since broadened its Prescription Drug List qualifier for paediatric melatonin, reflecting a wider regulatory approach to sleep-related use in children under 18.
Slenyto’s backers say its evidence base includes a 13-week placebo-controlled trial and a longer open-label follow-up period lasting 91 weeks, with data supporting its safety, tolerability and effect on sleep. In a release, Shelly Weiss, a paediatric neurologist at SickKids, said families often struggle with inconsistent over-the-counter melatonin use, and described the prescription option as the first extended-release treatment specifically developed, studied and approved for children with autism spectrum disorder in Canada.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
