Health Canada has changed the Prescription Drug List qualifier related to pediatric melatonin use: Notice of amendment

Published: June 2, 2026
Our file number: 26-103029-408

On this page

• Overview
• How the melatonin listing has changed
• Why we're making the change
• Next steps

Overview

Health Canada has changed the listing for "melatonin or its salts" on the human use part of the Prescription Drug List. The change to the qualifier in the listing captures all sleep-related uses in children and adolescents under 18 years of age (pediatric use). This means that drugs containing melatonin for pediatric sleep-related use are prescription drugs under the Food and Drug Regulations.

We made the change after consulting with the public on the proposal.

Learn more:

• Notice of consultation (September 16, 2025)
• Notice of intent (May 26, 2026)

How the melatonin listing has changed

The previous human use listing read:

The new human use listing reads:

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 (NHP) under Schedule 1 of the Natural Health Products Regulations or as a prescription drug under the Food and Drug Regulations. Currently, all licensed 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 (NNHPD) Melatonin – Oral monograph (2024)
• NNHPD Melatonin – Sublingual monograph (2024)

There are currently no non-prescription drugs or NHPs that contain melatonin authorized for use in children and adolescents in Canada. However, there is one authorized prescription drug, Slenyto, regulated under the Food and Drug Regulations. It is for treating insomnia in children and adolescents, aged 2 to under 18, with Autism Spectrum Disorder or Smith-Magenis syndrome.

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

1. 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
2. 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, Health Canada considers it necessary for a health care practitioner to supervise the pediatric use of melatonin in order 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

This Prescription Drug List change does not affect any currently licensed melatonin-containing NHPs. These products are all indicated for adults only and still subject to the Natural Health Products Regulations. Slenyto, the one prescription drug authorized under the Food and Drug Regulations for pediatric use, will continue to fall within the amended qualifier on the Prescription Drug List.

Learn more:

• Guidance document: Determining prescription status for human and veterinary drugs

Next steps

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