Kye Pharmaceuticals has launched Slenyto, the first prescription extended-release melatonin tablet for children and adolescents in Canada, amid new regulations on paediatric melatonin use.
Kye Pharmaceuticals says Slenyto, an extended-release melatonin tablet, is now available in Canada as a prescription treatment for insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome. The Canadian company said it has a licensing and distribution agreement with Neurim Pharmaceuticals to manage regulatory, commercialisation and distribution work for the product in Canada. Health Canada authorised the drug earlier this year, according to company and regulatory notices.
Health Canada said the move fits a broader tightening of rules around paediatric melatonin. From June 2, 2026, medicines containing melatonin for sleep-related use in people under 18 are classified as prescription drugs, a change the regulator said is meant to ensure healthcare practitioners oversee use in children and teenagers and monitor possible health issues. That policy shift makes Slenyto’s arrival notable, as it is described as the first prescription melatonin in the Canadian market.
The product is indicated for patients aged 2 to under 18 with autism spectrum disorder or Smith-Magenis syndrome, both of which are linked with significant sleep problems. Neurim and later industry coverage have said the treatment addresses an unmet need because it was specifically developed and studied for this group, rather than being adapted from general over-the-counter melatonin products.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
