- Kye Pharmaceuticals announced that Slenyto (melatonin extended-release tablets) is now available across Canada by prescription for insomnia in children and adolescents aged 2 to <18 with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome (SMS).
- Slenyto received Health Canada’s Notice of Compliance in September 2025. It is the first and only prescription melatonin therapy in Canada with a purpose-designed pediatric formulation for this population.
- The extended-release formulation mimics natural nighttime melatonin secretion and comes as an odourless, tasteless 3mm mini-tablet. Its safety and efficacy were evaluated in a 13-week placebo-controlled trial and 91-week open-label period.
- Slenyto addresses an unmet need for pediatric patients whose sleep hygiene measures are insufficient. The therapy is now available through pharmacies nationwide, offering clinicians a specifically developed and studied extended-release option.
Takeaways:
Slenyto gives Canadian clinicians a prescription, extended‑release melatonin specifically studied for children and teens (ages 2 to <18) with autism spectrum disorder and/or Smith‑Magenis syndrome whose sleep problems persist despite good sleep habits. Its small, tasteless mini‑tablets and slow‑release design aim to better match natural nighttime melatonin levels, which can help kids fall asleep faster and stay asleep longer while giving families a consistent, regulated alternative to over‑the‑counter melatonin products.
Source: CA Newswire
