ApprovalTrail

Natural health product · NPN 80100481

Melatonin

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 May 20, 2020.
Natural Product Number (NPN)
80100481
Licence holder
New Roots Herbal Inc.Vaudreuil-Dorion, Quebec, Canada
Dosage form
Tablet, Delayed Release
Route
Oral
Licensing route
General (non-traditional)
First licensed
May 20, 2020

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide5 mg

What it is licensed for

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

  • 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 re-set the body's sleep-wake cycle (aspect of the circadian rhythm). Helps to prevent and/or reduce the effects of jet lag/minimize jet lag (e.g. daytime fatigue, sleep disturbance) (for people travelling by plane easterly across two or more time zones/if 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.

Non-medicinal ingredients

Hyprolose; Dicalcium phosphate; Magnesium stearate; Stearic acid; Microcrystalline cellulose; Silicon dioxide