Health | Regulation
Canada Now Requires a Prescription for Melatonin for Children's Sleep
Since June, melatonin for sleep in anyone under 18 is a prescription drug in Canada. Across the border, children's poisonings from the supplement rose 530% in a decade.
A bottle of melatonin gummies for a child who will not settle at night has become an ordinary sight in many homes. In Canada, it is now one that needs a doctor's signature.
Health Canada added melatonin for sleep related use in children and adolescents under 18 to its Prescription Drug List. The change took effect on June 2, 2026, after a notice of intent on May 26.
What changed
The rule builds on a narrower listing from September 9, 2025, which covered children aged 2 to under 18 with autism spectrum disorder or Smith Magenis syndrome. The 2026 change widens it to sleep related use in all children and teenagers.
Melatonin products currently licensed in Canada as natural health products are for adults only, and they are not affected. Slenyto, a prolonged release melatonin, is the prescription product for children.
The numbers behind the worry
Canada's move follows years of warnings from the US, where melatonin is sold as a dietary supplement and often in fruit flavoured gummies.
- US poison centers logged 260,435 melatonin ingestions in people aged 19 and under from 2012 to 2021, according to the CDC.
- Yearly reports rose from 8,337 in 2012 to 52,563 in 2021, up 530%. The biggest one year jump came between 2019 and 2020.
- 83.8% of the children were aged 5 or under, and about 94% of cases were accidental.
- 4,097 children were hospitalised. Five needed a breathing machine, and two children under the age of 2 died.
A 2024 CDC report found about 11,000 US emergency department visits from 2019 to 2022 by infants and young children who swallowed melatonin unsupervised. Gummies were the most common form.
The label problem
A 2023 study in JAMA tested 25 US melatonin gummy products and found that 22 did not contain the amount on the label, with actual melatonin ranging from 74% to 347% of the stated dose. The authors warned that, taken as directed, the gummies could expose children to 40 to 130 times more melatonin than the body makes.
In the US, the industry's Council for Responsible Nutrition adopted voluntary guidelines in March 2024 calling for child deterrent packaging and warning labels on flavoured melatonin. Federal law does not require child deterrent packaging for it.
What sleep doctors tell parents
The American Academy of Sleep Medicine's 2022 health advisory asks parents to talk to a pediatric health professional before giving melatonin or any supplement to a child.
It says many children's sleep problems are better handled by changes to schedules, habits and behaviour, and that melatonin, if used, should be kept out of children's reach.