In Canada, Pediatric Prescription Melatonin for Insomnia in Autism, Smith-Magenis Syndrome Becomes Available

Key takeaways:

• A prescription extended-release melatonin is now available in Canada for pediatric patients with autism spectrum disorder and Smith-Magenis syndrome.
• The treatment is formulated as an odorless, tasteless 3 mm mini-tablet designed to mimic natural nighttime melatonin secretion.
• The rollout follows a licensing and distribution agreement to bring the purpose-designed therapy to the Canadian market.

SLENYTO (melatonin extended-release tablets) is now available across Canada by prescription for the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and/or Smith-Magenis syndrome.

The therapy, which received a Notice of Compliance from Health Canada in September 2025, is designed to mimic the natural nighttime secretion of melatonin. It is formulated as a pediatric-appropriate odorless, tasteless 3 mm mini-tablet. The availability follows a licensing and distribution agreement between Kye Pharmaceuticals and Neurim Pharmaceuticals.

“In my practice, I see a high variability with how families select, dose, or benefit from a multitude of over-the-counter melatonin health supplements to support sleep,” says Shelly Weiss, MD, a pediatric neurologist at SickKids, in a release. “SLENYTO gives clinicians the first extended-release option specifically developed, studied and approved for children with autism spectrum disorder in Canada.”

According to the companies, sleep disturbances are a highly prevalent comorbidity in this patient population:

• Prevalence of autism spectrum disorder among children and youth aged 1 to 17 years is about 2% (1 in 50) and is equivalent to about 150,000 cases in Canada in 2025. Smith-Magenis syndrome is a very rare (1:15,000 to 1:25,000 births) genetic neurodevelopmental disorder that affects behaviors, emotions, and learning processes, and roughly 300–500 children in Canada aged 1–17 may have Smith-Magenis syndrome in 2025.
• Between 50-80% of children with autism spectrum disorder and Smith-Magenis syndrome experience insomnia, much more than typically developing children.

“We are proud to bring the first and only prescription melatonin therapy with a purpose-designed pediatric formulation for this patient population to Canada,” says Julian Oliver, commercial lead, general medicines & business operations, Kye Pharmaceuticals, in a release. “SLENYTO addresses a significant unmet need for children and adolescents with insomnia and ASD and/or SMS, as well as their families and the physicians who care for them.”

The efficacy, safety, and tolerability of the treatment were established through a 13-week placebo-controlled clinical trial and a 91-week open-label period assessing the effects of long-term use in children and adolescents.

“It is the only melatonin-based treatment developed specifically for children with neurodevelopmental disorders, offering a safe and effective solution that improves both sleep and daytime functioning,” says Nava Zisapel, founder and chief scientific officer at Neurim Pharmaceuticals, in a release.

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