Canada Consults on Reclassifying Pediatric Melatonin as a Prescription Drug

On September 16, 2025, Health Canada initiated a 75-day public consultation on a proposal to require a prescription for all melatonin products sold for sleep-related purposes in children and adolescents under 18 years of age. The proposed amendment to the human use part of the Prescription Drug List (PDL) aims to ensure healthcare practitioner oversight for this population. Interested stakeholders have until December 30, 2025, to provide comments.