Melatonin
Natural health product licensed in Canada
- Other names
- Melatonin 3mg, Sleep FX, clear zzz's
- Licence holder
- Xymogen
- NPN or DIN-HM
- 80025414
- Status
- Active licence
- Licence date
- 19 May 2011
- Revision date
- 16 March 2026
- Form
- Pastille
- Route of administration
- Sublinguale
- Application type
- Officinale
Oral dose analysis does not apply without an established exclusively oral route.
Composition
| Medicinal ingredient and source | Per dosage unit, according to the source |
|---|---|
| Mélatonine Source : Synthétique | 3 mg |
Non-medicinal ingredients
Acide stéarique, Stéarate de magnésium, D-Mannitol, Saveur de menthe poivrée, Xylitol, Silice
Recommended doses in Canada
| Population | Age | Quantity per serving | Frequency |
|---|---|---|---|
| Adultes | Not specified | minimum: 1 Pastille ; maximum: 2 Pastille | 1 Tous les jours |
Uses authorised in Canada
Helps increase the total sleep time (aspect of sleep quality) in people suffering from sleep restriction or altered sleep schedule, e.g. shift-work and jet lag. Helps relieve the daytime fatigue associated with jet lag. Helps re-set the body's sleep-wake cycle (aspect of the circadian rhythm). Helps to reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people with delayed sleep phase syndrome.
A use authorised in Canada is not an authorised health claim in the European Union. See the health claims register.
Warnings in Canada
- Précautions et mises en garde
If symptoms persist continuously for more than 4 weeks (chronic insomnia), consult your health care practitioner. Consult a health care practitioner prior to use if you have a hormonal disorder, diabetes, liver or kidney disease, cerebral palsy, seizure disorders, migraine, depression and/or hypertension or if you are taking blood pressure or sedative/hypnotic medications.
- Contre-indications
Do not use if you are taking immunosuppressive drugs. Do not use if you are pregnant or breastfeeding. Do not drive or use machinery for 5 hours after taking melatonin.
Source
Official Health Canada record, licence 80025414
Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks, retrieved 27 October 2026.
Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)
Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)
The formula sold in Europe under the same name may differ. This information does not replace advice from a doctor or pharmacist.
List in the official revision dated (register: Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks).
Has the product changed? Photograph the packaging.