ApprovalTrail

Natural health product · NPN 80025983

Melatonin SAP

Yes: licensed in Canada

The product licence is active. Whether the product is actually on the market is a separate, voluntary notice; the official record shows it.

Licence status Active; licensed June 24, 2011; licence last revised November 18, 2024.
Natural Product Number (NPN)
80025983
Dosage form
Tablet
Route
Oral
Licensing route
Compendial
First licensed
June 24, 2011
Licence last revised
November 18, 2024

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
Melatonin3 mg

What it is licensed for

The licence’s own wording. Directions, doses, cautions and warnings are on the official record and the label.

  • (Used as a) sleep aid (to help promote sleep). 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 (to) prevent and/or reduce the effects of jet lag/minimize jet lag (e.g. daytime fatigue, sleep disturbance) (for people/if travelling by plane easterly across two or more time zones/flying east over two or more time zones). Helps (to) speed up/reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people who fall asleep slowly/with delayed sleep phase disorder. Helps (to) re-set the body's sleep-wake cycle (aspect of the circadian rhythm).

Non-medicinal ingredients

Cellulose; Stearic Acid; Dibasic calcium phosphate; Croscarmellose Sodium; Silicon dioxide; Magnesium Stearate