What can you say about melatonin in your ads and on your site?

The library supports 5 wordings for melatonin; the strongest is “Helps you fall asleep faster when sleeplessness is occasional” (strong, 0.1-10 mg a day). Avoid wording that names or implies a disease, a drug or a treatment, such as “Treats insomnia”.

Also called: N-acetyl-5-methoxytryptamine, Pineal hormone

Reviewed 14 October 2026

Not legal advice. This guide shows the wording that published evidence supports at a daily dose, from the sources linked below; it is not a ruling on any claim. Your own product, its form and dose, and your own evidence still need to match the wording you use.

Supported wordings

What you can say.

Strong evidenceWording 1

Claims Facts

“Helps you fall asleep faster when sleeplessness is occasional.”

Daily dose	0.1-10 mg a day
Support	Authorized in the EU after EFSA review at 1 mg, and listed by Health Canada at a range that includes 1 mg.
Dose details	EU: 1 mg taken close to bedtime, and the consumer is told so. Health Canada: 0.1-10 mg a day, taken 30-60 minutes before bedtime, for adults 18 and older who fall asleep slowly. The two sources agree at about 1 mg.
Form	Melatonin taken by mouth
Sources	Commission Regulation (EU) No 432/2012, list of permitted health claims Health Canada monograph: Melatonin - Oral

Strong evidenceWording 2

Claims Facts

“Helps ease jet lag, such as daytime tiredness and disturbed sleep.”

Daily dose	0.5-10 mg a day
Support	Authorized in the EU after EFSA review and listed by Health Canada at overlapping doses.
Dose details	EU: at least 0.5 mg taken close to bedtime on the first day of travel and the following few days. Health Canada: 0.5-10 mg a day, 30-60 minutes before bedtime, adults 18 and older.
Form	Melatonin taken by mouth
Sources	Commission Regulation (EU) No 432/2012, list of permitted health claims Health Canada monograph: Melatonin - Oral

Moderate evidenceWording 3

Claims Facts

“Helps reset the body’s sleep-wake cycle.”

Daily dose	0.1-10 mg a day
Support	Health Canada lists it; no other listed source covers this wording.
Dose details	Adults 18 and older, 30-60 minutes before bedtime.
Form	Melatonin taken by mouth
Source	Health Canada monograph: Melatonin - Oral

Moderate evidenceWording 4

Claims Facts

“Helps increase total sleep time when sleep is cut short or the sleep schedule shifts, as with shift work or jet lag.”

Daily dose	0.1-10 mg a day
Support	Health Canada lists it; no other listed source covers this wording.
Dose details	Adults 18 and older, 30-60 minutes before bedtime.
Form	Melatonin taken by mouth
Source	Health Canada monograph: Melatonin - Oral

Moderate evidenceWording 5

Claims Facts

“Helps relieve occasional sleeplessness.”

Daily dose	0.1-10 mg a day
Support	Health Canada lists it; the EU’s narrower claim covers falling asleep faster, not sleep in general.
Dose details	Adults 18 and older, taken as needed 30-60 minutes before bedtime.
Form	Melatonin taken by mouth
Source	Health Canada monograph: Melatonin - Oral

How strong the evidence is

Strong evidence: At least two listed sources support it independently at a comparable dose and form, and none disagrees.
Moderate evidence: One listed source supports it as an evidence-based use at that dose, and no listed source disagrees.
Limited evidence: The only support is traditional use, the sources disagree, or the source itself calls the evidence weak.

Wordings to avoid

What to leave out.

Claims Facts

Ingredient: Melatonin

Wording to avoid	Reason
“Treats insomnia”Insomnia is a diagnosable sleep disorder; the supported wording is about falling asleep faster and the sleep-wake cycle.	Disease
“Treats delayed sleep phase disorder, or other sleep disorders”Names a disorder. Health Canada’s own wording mentions people with delayed sleep phase disorder, but in a disease-claim review that names a disease.	Disease
“A drug-free sleeping pill, or works like a prescription sleep medicine”Compares the product to a drug.	Drug
“Helps you fall asleep if you have difficulty falling asleep”FDA’s 2000 rule (page 1031) says this implies treating insomnia unless the context makes clear the product is only for occasional sleeplessness.	Disease
“Helps you fall asleep, without ‘occasional’”FDA’s 2000 rule (page 1031) says help falling asleep implies treating insomnia unless the context makes clear the product is only for occasional sleeplessness.	Disease

Disease: names or implies a disease. Drug: names a drug or presents the product as one. Treatment: promises to treat, cure or prevent a condition.

Sources

Where this comes from.

All ingredient guides

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