Canada Approves First Prescription Melatonin for Pediatric Sleep Disorders

The medication is approved for children and adolescents aged two to 18 living with autism spectrum disorder (ASD) or Smith-Magenis syndrome (SMS). Unlike over-the-counter supplements, this formula is designed to mimic natural nighttime melatonin secretion, using an odourless, tasteless 3mm mini-tablet to facilitate administration.

Clinical evidence for the treatment includes a 13-week placebo-controlled trial followed by a 91-week open-label study to track long-term safety and efficacy. Dr. Shelly Weiss, a pediatric neurologist at SickKids and former president of the Canadian Sleep Society, noted that the product provides clinicians with a standardized, studied option for a population that frequently experiences disrupted circadian rhythms. Kye Pharmaceuticals confirmed the drug is now available through pharmacies nationwide following a Notice of Compliance issued by Health Canada.