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Natural Product Number (NPN):
80068400
Market status:
Marketed
Licence Status:
Active
Brand name(s):
Melatonin 10 mg
Licence holder:
New Roots Herbal Inc.
Dosage Form:
Tablet
Recommended route of administration:

Oral

Recommended dose:
Sub population (Sub Pop.) Quantity (Qty) Frequency (Freq.)
Sub Pop. Age Min. Max. UoM Footnote1 Age Qty Min. Max. UoM Qty Freq. Min. Max. UoM Freq.
Adults 0.5 1.0 tablet 1 daily
Recommended use or purpose:
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 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. Helps to re-set the body's sleep-wake cycle (aspect of the circadian rhythm).
Risk Information:
Cautions and Warnings 
Consumption with alcohol, other medications or natural health products with sedative properties is not recommended. If you are taking one of the following medications, consult a health care practitioner prior to use: anticoagulant, anticonvulsant, blood pressure medications, immunosuppressive medications, sedative, hypnotic or psychotropic medications, or steroids. If you have one of the following conditions, consult a health care practitioner prior to use: asthma, cardiovascular disease, chronic kidney disease, depression, diabetes or hypoglycaemia, hormonal disorder, immune system disease, liver disease, migraine, or seizure disorders. Sleep restriction/altered sleep schedule; delayed sleep phase disorder; sleep-wake cycle: If symptoms persist continuously for more than 4 weeks (chronic insomnia), consult your health care practitioner. All uses except jet lag: Consult your health care practitioner if sleeplessness persists for more than 4 weeks (chronic insomnia). Avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2009; Holliman and Chyka 1997). Consult a health care practitioner prior to use if you are taking medications for seizure, blood pressure, to suppress the immune system (immunosuppressive medications), to affect mental state or increase sedation, steroids or blood thinners. Consult a health care practitioner prior to use if you have cardiovascular, immune, liver or chronic kidney disease, hormonal or seizure disorders, asthma, depression, diabetes, low blood sugar, or migraine.
Contra-Indications 
If you are pregnant or breastfeeding, do not use this product. Do not use this product if you are pregnant or breastfeeding. Do not drive or use machinery for 5 hours after taking melatonin.
Known Adverse Reactions 
Mild gastrointestinal symptoms (nausea, vomiting, or cramping) have been known to occur in which case, discontinue use. Rare allergic reactions have been known to occur in which case, discontinue use. Stop use if allergy occurs or if you experience headache, confusion, or nausea.
List of medicinal ingredients:
Medicinal ingredients Quantity (Qty) Extract Potency
N-Acetyl-5-methoxytryptamine 10.0 milligrams
List of non-medicinal ingredients:
  • Croscarmellose Sodium
  • Dicalcium Phosphate
  • Magnesium Stearate
  • Microcrystalline cellulose
  • Silicon dioxide
  • Stearic Acid
Date of licensing:
2016-04-11
Revised date of licence:
2024-03-10

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