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Consultation: Adding melatonin for sleep-related use in the pediatric population to the Prescription Drug List

Current status: Open

Opened on September 16, 2025 and will close to new input on December 30, 2025.

The purpose of this consultation is to communicate to industry, practitioners and the public about Health Canada's proposed approach to regulating melatonin products that would be intended for sleep-related use in the pediatric population as prescription drugs under the Food & Drug Regulations. We want to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Melatonin or its salts" on the human use part of the Prescription Drug List (PDL).

Specifically, the proposal is to broaden the qualifier to capture all sleep-related uses in the pediatric population (i.e., all children and adolescents under 18 years of age). The intent of this proposal is to help ensure healthcare practitioner oversight on the use of melatonin products for sleep-related purposes in children and adolescents under 18 years of age.

The current listing on the human use part of the PDL is
Drugs containing any of the following Including (but not limited to) Qualifier
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
The proposed revised listing on the human use part of the PDL is
Drugs containing any of the following Including (but not limited to) Qualifier
Melatonin or its salts N/A when sold for sleep-related use in children and adolescents under 18 years of age

Join in: How to participate

Comments on this proposed change to the PDL should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice to:

Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

Or you may send your comments to:

Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address locator: 3106C
1600 Scott Street
Ottawa ON K1A 0K9

If there are questions about this proposal, please contact Health Canada.

Who is the focus of this consultation

We will engage with:

Rationale

Melatonin is a hormone that plays a key role in regulating the sleep-wake circadian rhythm. Melatonin is generally classified as a Natural Health Product (NHP), under Schedule 1 of the Natural Health Products Regulations (NHPR). 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) and NNHPD Melatonin – Sublingual monograph (2024). In Canada, there are currently no NHPs that contain melatonin that are authorized for use in children and adolescents, and there is one drug (Slenyto) containing melatonin authorized as a prescription drug under the Food and Drug Regulations (FDR) for the treatment of insomnia in children and adolescents aged 2 to <18 years with Autism Spectrum Disorder and / or Smith-Magenis syndrome.

Based on the available evidence, including international pediatric guidelines highlighting the importance of performing a thorough clinical evaluation to rule out other causes of chronic insomnia before considering melatonin for use in children, Health Canada is proposing to broaden the melatonin qualifier on the PDL to the entire pediatric population when sold for a sleep-related use.

Neurological adverse reactions with the use of melatonin in children and adolescents have been reported internationally, with the most common adverse reactions being general fatigue, aggression, abnormal dreams, and headache. International reports prompted Health Canada to conduct a safety review to determine whether there were risks associated with pediatric melatonin use in Canada. In December 2015, a Safety Summary Review (SSR) found that a causal association between the use of melatonin and serious adverse reactions could not be established. The public was advised to consult a healthcare practitioner if considering giving melatonin to children or adolescents. In November 2023, following increased domestic reports of accidental ingestion of melatonin in young children, a Health Product InfoWatch article advised the public to keep melatonin products out of children's reach. In these cases, there was no evidence that the accidental ingestion harmed the children.

In 2015, two NHPs containing melatonin had been licensed by Health Canada for use in the subpopulation of adolescents 12 years of age and older; however, these products were never marketed in Canada and the licence holder discontinued the licences in 2023. Since that time, no melatonin-containing NHPs have been licensed for use in children or adolescents.

Health Canada is considering whether a melatonin product for a sleep-related use in all children and adolescents under 18 years of age should be a prescription drug based on the PDL principles set out in C.01.040.3 of the FDR and associated factors.

Given the evidence reviewed to date, Health Canada is of the view that paragraph C.01.040.3(a) of the FDR applies to such a melatonin product:

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 believes that supervision by a healthcare practitioner is necessary to ensure that good sleep-hygiene measures have been attempted prior to melatonin use, and that there are no underlying health issue(s) that would be causing sleep problems. In addition, the selection of an appropriate dose based on the patient's condition (for example, their age, weight, medical history, concomitant medications) and therapeutic needs would need to be determined by a healthcare practitioner.

This proposed amendment would not impact any currently licensed melatonin-containing NHPs as they are indicated for adults only, and there are no non-prescription drugs that contain melatonin and are licensed for use in children or adolescents.

Should Health Canada amend the PDL, a health product containing melatonin for sleep-related use in children and adolescents under 18 years of age would be a prescription drug and subject to the FDR. Health products containing melatonin currently licensed for adult use only will remain subject to the NHPR.

In Australia and Europe, melatonin for use in children and adolescents is currently sold pursuant to a prescription. Thus, if Health Canada makes melatonin for sleep-related uses in children and adolescents a prescription drug, Canada will be aligned with a number of other regulators.

More information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Health Canada will consider all comments received about this notice. Should Health Canada proceed with the amendment, a Notice of Intent will be posted to inform stakeholders of Health Canada's decision, and the notice will provide a summary of the comments received.

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From:

2025-09-16