Notice of amendment: Addition of melatonin to the Prescription Drug List
September 9, 2025
Our file number: 25-105825-747
The purpose of this Notice of Amendment is to announce the addition of "melatonin or its salts" to the human use part of the Prescription Drug List (PDL). This addition will not be made to the veterinary use part of the PDL.
| 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 |
This addition is effective at the time of posting.
Rationale
A scientific review of this drug containing melatonin for the treatment of insomnia in children and adolescents aged 2 to < (less than) 18 years with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome (SMS) against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that melatonin or its salts with these conditions of use requires prescription status.
Slenyto (melatonin extended-release tablets) is indicated for:
- the treatment of insomnia in children and adolescents aged 2 to <18 years with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome (SMS), where sleep hygiene measures have been insufficient.
Slenyto has not been studied in children under 2 years of age and there is no indicated use of Slenyto in children aged 0 to 2 years for the treatment of insomnia. Therefore, Health Canada has not authorized an indication in this patient population.
Next steps
While the qualifier for this entry is specific to the pediatric population with ASD and/or SMS, Health Canada intends to propose broadening the qualifier for the “melatonin or its salts” PDL entry to capture any sleep-related use in the general pediatric population. The public and interested stakeholders will be notified and provided with the opportunity to comment on this proposal through a Notice of Consultation, which will be published following the publication of this notice.
Should you have any questions about this notice, please 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