Melatonin dosage: 0.5, 1, 2, 5 or 10 mg?
Futures Nutrition Editorial Team · 11 August 2026
Melatonin dosage: 0.5, 1, 2, 5 or 10 mg?
11 August 2026
On the shelf, 0.5 mg stands next to 1 mg, 2 mg, 5 mg and 10 mg, and anyone looking at that reads a scale into it: little, medium, a lot. Legally, that scale does not exist. European food law knows exactly two amounts for melatonin — 1 mg per portion for the claim on falling asleep and 0.5 mg for the jet lag claim. Anything above that does not make the authorised claim stronger. It leads into a quite different question, namely whether a product is still a food at all.
Melatonin contributes to the reduction of time taken to fall asleep. The beneficial effect is obtained with the consumption of 1 mg of melatonin close to bedtime.
The authorisation knows two numbers, not five
Both claims appear in Regulation (EU) No 432/2012, the list of authorised health claims. For each one it is laid down under which condition the claim may be used at all:
| Authorised claim | Amount per portion | Condition the consumer must be informed of |
|---|---|---|
| Melatonin contributes to the reduction of time taken to fall asleep. | 1 mg | The beneficial effect is obtained with the consumption of 1 mg of melatonin close to bedtime. |
| Melatonin contributes to the alleviation of subjective feelings of jet lag. | at least 0.5 mg | The beneficial effect is obtained with the consumption of at least 0.5 mg of melatonin close to bedtime on the first day of travel and on the first few days after arrival at the destination. |
Three things about this table matter more than they look.
First: the number is a condition, not a recommended intake. It says from when a manufacturer may print the sentence on the pack — not how much someone should take.
Second: it refers to the portion, not to the tablet. If a pack contains 0.5 mg per tablet and states two tablets as the portion, the condition for the falling-asleep claim is met. If another pack has 1 mg per tablet with a portion of one tablet, likewise. The "per portion" figure in the nutrition table is therefore the only number that means the same thing across two products.
Third: upwards the claim is open — in substance, not in law. There is no authorised claim that only applies from 5 or 10 mg. Whoever buys 10 mg is not buying a stronger statement, only more milligrams.
The strengths in our range and how they fit the condition
| Strength | Relation to the authorised claim | In practice |
|---|---|---|
| 0.5 mg | meets the jet lag condition (at least 0.5 mg) | two tablets make 1 mg |
| 1 mg | matches the falling-asleep condition exactly | one tablet, no arithmetic |
| 2 mg, divisible | half a tablet = 1 mg | the score line allows both amounts from one pack |
| 5 mg | above both conditions | no additional authorised claim |
| 10 mg | clearly above both conditions | no additional authorised claim |
For the jet lag claim, the smallest strength is the one that fits precisely: our melatonin 0.5 mg meets the 0.5 mg condition with a single tablet and can be doubled to reach 1 mg.
Anyone who wants to land on exactly 1 mg without keeping two packs takes a divisible tablet. The melatonin 2 mg with a score line is made for that: half a tablet matches the condition of the falling-asleep claim, a whole one lies above it.
The higher strengths — melatonin 5 mg and melatonin 10 mg — lie above what the authorisation describes. That is not a judgement but a placement: they are not "the strong version" of the same statement, they stand outside its frame of reference. The melatonin category gives an overview of all strengths.
Why more milligrams do not add up to a stronger statement
The reason lies in how such claims come about. A specific amount is assessed against a specific statement; exactly that combination is then authorised. For melatonin this was 1 mg close to bedtime, and 0.5 mg for the jet lag claim. An assessment supporting an additional statement for 5 or 10 mg does not exist — and therefore neither does a claim that could rest on it.
There is also the yardstick: the body produces melatonin itself, and the amounts involved are very small. Even 1 mg as a tablet lifts the blood level far beyond what arises on its own at night. Jumping to 5 or 10 mg therefore widens a gap that is already clear at 1 mg.
The term "high dose" is not legally defined. It describes no verified property but relates to a reference point the manufacturer chooses. The only meaningful figure is the number of milligrams per portion. How long melatonin remains detectable in the body after intake, and what that means for the following morning, is covered in Melatonin duration: how long does it act in the body?.
Where medicines law begins
This is where it gets murky, and it is more honest to say so. In Germany, melatonin falls into two areas of law at the same time.
There are authorised medicinal products containing melatonin, prescription-only, typically prolonged-release tablets of 2 mg — for instance Circadin, Melatonin AL or Melatonin-ratiopharm. They are authorised for the short-term treatment of primary insomnia in patients aged 55 and over, for a period of up to 13 weeks. The difference from a food supplement is not only the amount: a prolonged-release tablet gives off the substance over hours, an ordinary tablet all at once.
And there are food supplements containing melatonin, freely available. Whether an individual product belongs to one category or the other is not a matter of a fixed milligram threshold but a case-by-case decision — legally, the question of whether it is a medicinal product by function. Authorities and courts remain inconsistent on this to this day:
- Germany's BfArM classified melatonin-containing products as medicines back in 2011, irrespective of dose.
- Germany's BVL classified a product with 3 mg per capsule as a medicinal product by function; the proceedings before the Braunschweig Administrative Court (5 A 113/13) ended in 2018 when the action was withdrawn, so without a decision.
- Civil and administrative courts have not followed that line consistently. Decisions of the Frankfurt am Main Higher Regional Court (11.03.2021) and the Münster Higher Administrative Court (28.10.2021) proceeded on the basis that melatonin-containing products in low amounts are marketable as foods.
Supervision lies with the food surveillance authorities of the federal states rather than a federal agency — which also contributes to identically built products being judged differently.
What the German Federal Institute for Risk Assessment notes
The BfR commented in 2024 on food supplements containing melatonin (opinion No 42/2024). The core point: certain groups are advised against taking them on their own initiative and without supervision — children and adolescents, pregnant and breastfeeding women, people with impaired liver or kidney function, with autoimmune conditions or epilepsy, people at increased risk of type 2 diabetes, and users of blood pressure-lowering or anticoagulant medicines.
As undesirable effects the institute names, among others, sleepiness the following day, headache, reduced attention, prolonged reaction times and a drop in blood pressure. Such effects have also been reported at comparatively low amounts of 1 mg and below — the amount alone therefore does not tell you whether someone will notice anything. Anyone taking medicines or living with one of the conditions listed is well advised to settle the question with a doctor. Why alcohol on the same evening plays a role of its own is covered in Alcohol and melatonin.
Food supplements are not a substitute for a balanced and varied diet and a healthy lifestyle.
The short version
- For the falling-asleep claim, 1 mg per portion applies, close to bedtime.
- For the jet lag claim, 0.5 mg is enough, on the first day of travel and the first days after.
- Portion ≠ tablet — the decisive figure is in the nutrition table.
- Higher strengths carry no additional authorised claim.
- Where the boundary to a medicine runs is, in Germany, not conclusively settled.
Frequently asked questions
Which amount is stated in the authorised claim?
1 mg per portion for the falling-asleep claim, at least 0.5 mg for the jet lag claim. Both appear in Regulation (EU) No 432/2012, and both claims must be given together with their condition.
Do 10 mg work ten times as well as 1 mg?
That is not how the authorisation works. It describes an amount and a statement; a statement that grows with the amount does not exist. Anyone who wants to go by the authorised claim goes by 1 mg.
May melatonin tablets be divided?
Only if they are made for it. A score line and the wording "divisible" are the criterion; with coated or prolonged-release tablets, splitting is not intended, because it changes the release.
Why is melatonin available on prescription and over the counter at the same time?
Because two areas of law are involved. An authorised medicine has a therapeutic indication, a verified dosage form and prescription status; a food supplement has a portion statement and may carry only the authorised claim. That both contain the same substance does not make them the same product.
Matching products from our range
- Melatonin 0.5 mg – 365 tablets
- Melatonin 2 mg, divisible to 1 mg – 180 tablets
- View all melatonin products
Sources: Regulation (EU) No 432/2012 (authorised health claims, melatonin: falling asleep 1 mg, jet lag 0.5 mg); German Federal Institute for Risk Assessment (BfR), opinion No 42/2024 "Melatonin-containing food supplements: BfR points out possible health risks"; German BVL, FAQ "Court proceedings on melatonin-containing products – food/medicine delimitation" (Braunschweig Administrative Court, 5 A 113/13); BfArM, classification of melatonin-containing products, 2011; Frankfurt am Main Higher Regional Court, 11.03.2021; Münster Higher Administrative Court, 28.10.2021; summary of product characteristics, Circadin 2 mg prolonged-release tablets.
