Notice of intent: Health Canada is changing the Prescription Drug List qualifier related to pediatric melatonin use
Published: May 26, 2026
Our file number: 26-103029-408
On this page
- Overview
- How the melatonin listing is changing
- Consultation summary
- Why we're making the change
- No impacts on currently authorized products
- Next steps
Overview
Health Canada will change the listing for “melatonin or its salts” on the human use part of the Prescription Drug List on June 2, 2026. The change to the qualifier in the listing will capture all sleep-related uses for children and adolescents under 18 years of age (pediatric use). This means that drugs containing melatonin for pediatric sleep-related use will be prescription drugs under the Food and Drug Regulations.
We’re making this change after consulting the public on the proposal.
Learn more:
- Notice of consultation (September 16, 2025)
How the melatonin listing is changing
| Drugs containing any of the following | Including (but not limited to) |
Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
| Melatonin or its salts | n/a | when sold for the treatment of insomnia in those 2 to under 18 years of age with Autism Spectrum Disorder and / or Smith-Magenis syndrome | 2025-09-09 |
| Drugs containing any of the following | Including (but not limited to) |
Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
| Melatonin or its salts | n/a | when sold for sleep-related use in children and adolescents under 18 years of age | 2026-06-02 |
Consultation summary
Health Canada ran a consultation on this change to the melatonin listing on the Prescription Drug List from September 16 to December 30, 2025.
We received 12 comments on the proposal from the following key stakeholder groups:
- academics
- members of the public
- health care practitioners
- provincial health services
- healthcare associations and societies
Stakeholders who supported the change said:
- it’s important to have medical supervision in children and adolescents taking melatonin for sleep-related use to:
- rule out other reasons for sleep disturbances
- make sure patients get the right diagnosis
- support proper dosing and monitoring
- patients may be encouraged to try non-medical interventions first (such as behavioural and family-based interventions)
There was a suggestion to broaden all melatonin products as prescription only.
Other stakeholders suggested that:
- increased costs associated with prescription drugs and limited access to family doctors could have a negative impact on access to the product and on timely care
- Health Canada could instead:
- reinforce labelling requirements and quality standards
- require pharmacist involvement instead of a prescription
- melatonin was safe enough, and had too few reported adverse reactions associated with its use to make it a prescription drug
Why we’re making the change
Melatonin is a hormone that helps to regulate sleep. In Canada, it is generally classified as a natural health product under Schedule 1 of the Natural Health Products Regulations or as a prescription drug under the Food and Drug Regulations.
Health Canada reviewed information and evidence about melatonin to date, including international pediatric guidelines. We concluded that paragraph C.01.040.3(a) of the Food and Drug Regulations applies to melatonin products for pediatric sleep-related use:
C.01.040.3(a) supervision by a practitioner is necessary
- for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
- to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug
Specifically, we consider it necessary for a health care practitioner to supervise the pediatric use of melatonin to:
- rule out any underlying health issues the patient may have that could cause sleep problems
- provide guidance to the patient or their caregiver on methods to improve sleep hygiene (which should be tried before using melatonin)
- prescribe the right dose for the patient based on their individual health needs and condition, including their age, medical history and other medications
We considered all consultation comments. However, the points raised didn’t change our conclusion that health care practitioners must supervise the use of melatonin to reduce the risk of harm to children and adolescents taking it for a sleep-related use. As such, we will change the Prescription Drug List so future health products containing melatonin for sleep-related use in those under 18 will be prescription drugs.
Learn more:
No impacts on currently authorized products
Currently, all licensed natural health products (NHPs) containing melatonin are indicated for adult use only and, where applicable, may include indications outlined in the:
- Natural and Non-prescription Health Products Directorate Melatonin – Oral monograph (2024)
- NNHPD Melatonin – Sublingual monograph (2024)
These products will remain subject to the Natural Health Products Regulations.
The change to the listing would not affect any authorized melatonin-containing NHPs, as there are currently no melatonin NHPs authorized for use in children or adolescents. There are also no non-prescription drugs that contain melatonin authorized for use in children or adolescents.
Slenyto is a prescription drug that is authorized to treat insomnia in children and adolescents aged 2 to under 18 with Autism Spectrum Disorder or Smith-Magenis syndrome. The change to the Prescription Drug List will not impact this drug. Slenyto will continue to fall within the amended qualifier on the Prescription Drug List.
Next steps
We will post a notice of amendment a week after posting this notice.
The 6-month transition period under the Technical Barriers to Trade Agreement will be omitted.
Once we amend the Prescription Drug List, sponsors who wish to market melatonin for sleep-related uses in the pediatric population should seek authorization under the Food and Drug Regulations with the Pharmaceutical Drugs Directorate.
If you have questions about this process, email bcansenquiries@hc-sc.gc.ca.
Applicants who wish to market melatonin for adult use only should submit a natural health product licence application to the Natural and Non-prescription Health Products Directorate.
If you have questions about this process, email nnhpd-dpsnso@hc-sc.gc.ca.
If you have questions about this notice, contact:
Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address locator 3106C
1600 Scott St
Ottawa ON K1A 0K9
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca