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Is melatonin safe? Dose, timing, children and who should not take it

Melatonin is a hormone your body makes at night, also sold as a food supplement. The EU sleep-onset claim needs exactly 1 mg close to bedtime, and melatonin is not for children, pregnancy or breastfeeding without a doctor.

Reviewed by Inese Kalniņa, dietitian

Is melatonin safe? Dose, timing, children and who should not take it

In short

  • EU sleep-onset claim applies only to exactly 1 mg of melatonin close to bedtime.
  • EU jet lag claim needs at least 0.5 mg close to bedtime, from the first day of travel.
  • Our labels say melatonin is not for children, pregnant or breastfeeding women.
  • Melatonin can cause drowsiness: no driving or heavy machinery after taking it.
  • 3 mg and 5 mg products have no authorised EU claim of their own.

Melatonin supplements are made for adults. The US National Center for Complementary and Integrative Health (NCCIH) says short-term use appears safe for most adults and that long-term data are lacking. Safe in that sense does not mean risk-free: labels say melatonin is not for children, pregnant or breastfeeding women, and that people on certain medicines need a doctor's advice first. In the EU, the sleep-onset claim is tied to one dose: 1 mg taken close to bedtime.

This guide covers what melatonin is, which two claims the EU allows, how much to take and when, and the warnings printed on the labels in our range.

What melatonin is

Melatonin is a hormone the body makes in the evening. A supplement contains the same molecule, made synthetically. The number on the label is the amount per portion, usually one capsule or tablet, and in our melatonin range it is 0.5 mg, 0.75 mg or 1 mg. Some products add lemon balm, valerian, saffron or B vitamins, so read the ingredient list as well.

What the EU allows us to say

With most nutrients, a bigger number on the label simply means more. With melatonin, Regulation (EU) No 432/2012 ties each authorised claim to a set amount per portion, and the label must tell you the conditions:

Melatonin per portion Authorised claim Condition that must be stated
Exactly 1 mg Melatonin contributes to the reduction of time taken to fall asleep The beneficial effect is obtained by taking 1 mg of melatonin close to bedtime.
At least 0.5 mg Melatonin contributes to the alleviation of subjective feelings of jet lag The beneficial effect is obtained with a minimum intake of 0.5 mg taken close to bedtime on the first day of travel and on the following few days after arrival at the destination.

So the sleep-onset claim does not apply to a 0.5 mg, 0.75 mg, 3 mg or 5 mg product. A 0.75 mg product can carry the jet lag claim only. Neither claim says anything about staying asleep through the night.

The claim is about falling asleep faster, not about treating any condition. Melatonin is a food supplement, not a medicine, and it does not replace seeing a doctor. If trouble falling asleep goes on for weeks, book an appointment.

How much melatonin to take and when

For the sleep-onset claim the amount is 1 mg, close to bedtime. Labels turn "close to bedtime" into a time, and the timing differs by brand. Always follow your own label and do not exceed the recommended daily dose.

Product Melatonin per portion Timing on the label
Yango, capsule 1 mg 1 capsule a day with plenty of water, after a meal
Swanson, capsule 1 mg 1 capsule half an hour before bed
OstroVit Keep Sleep, tablet 1 mg 1 tablet 30 minutes before bed
Life Extension, capsule 1 mg 1 capsule 30 to 60 minutes before bed
NOW Foods complex, tablet 1 mg 1 tablet about an hour before bed
Swanson, capsule 0.5 mg 1 capsule half an hour before bed

Yango

Melatonin, 1 mg, 90 Capsules

1 mg/day · €0,11/day

€9,99

Swanson

Melatonin, 1 mg, 120 Capsules

1 mg/day · €0,08/day

€9,49

OstroVit

Melatonin, 1 mg, Tablets

1 mg/day · €0,03/day

€8,49

Melatonin can cause drowsiness, so take it when you are ready to go to bed and not before a drive, a late shift or a task that needs attention. Several labels also say not to combine it with alcohol.

Melatonin and jet lag

The jet lag claim needs at least 0.5 mg close to bedtime, starting on the first day of travel and continuing for the next few days after you arrive. A 0.5 mg product such as the Swanson capsule meets the minimum, and a 1 mg product exceeds it, so either can carry the claim. Pick one amount and keep it the same on each of those days.

Swanson

Melatonin, 500 µg, 60 Capsules

500 µg/day · €0,16/day

€9,49

Is melatonin harmful? What the labels say

The warnings on our labels repeat a similar set of points:

  • Do not exceed the recommended daily dose.
  • May cause drowsiness. Do not drive or operate heavy machinery after taking it.
  • Not for pregnant or breastfeeding women.
  • Not for children. One brand states under 16 years, another under 18.
  • Talk to a doctor first if you take medicines, or have a health condition.

Those are precautions printed by manufacturers, not a verdict that melatonin is dangerous. The NCCIH lists headache, dizziness, nausea and daytime sleepiness as the most commonly reported side effects. Very little is known about what happens when people take it for years, which is a reason to use it for a specific purpose rather than as a permanent habit.

Melatonin for children

Do not give melatonin supplements to a child unless a doctor has recommended them. Our labels say "not for children", and the brand with the strictest wording sets 18 as the minimum age. The NCCIH notes that long-term safety in children has not been established. If your child has trouble falling asleep, start with a visit to the paediatrician, who can check for the cause and decide whether melatonin makes sense and at what dose.

Who should talk to a doctor first

Check with a doctor or pharmacist before taking melatonin if any of this applies to you:

  • you are pregnant, breastfeeding or planning a pregnancy
  • you take medicines, particularly sedatives, immunosuppressants or anticoagulants (blood thinners) as one label lists them
  • you have an autoimmune condition, a depressive disorder, diabetes, epilepsy or a heart and circulation condition

Labels also say not to combine melatonin with alcohol, and not to take it together with other medicines, including herbal ones, without asking. If you are unsure, show your pharmacist the full ingredient list.

3 mg or 5 mg: does a higher dose do more?

Shops often sell 3 mg and 5 mg melatonin, and shoppers search for them. For an EU supplement, the sleep-onset claim is authorised for 1 mg per portion, so that is the amount the claim and its wording are built on. Higher numbers do not come with an authorised claim of their own. More melatonin is not a better version of the same product: it is a different dose, with the same drowsiness warning and no added EU claim.

Drops, spray and slow-release: what changes

Melatonin comes in more forms than capsules, and each one turns milligrams into a different unit. Check how your label does it:

  • Drops: one NOW Foods liquid gives 1 mg in 7 drops, a Life Extension liquid gives 0.75 mg in 5 drops. Count the drops exactly.
  • Spray: the Aura Herbals spray gives 0.5 to 1 mg in 1 to 2 sprays. Shake it first. Its label warns that taking too much can have a laxative effect.
  • Slow-release: Life Extension makes a 6-hour timed-release tablet with 0.75 mg, and Kenay a prolonged-release capsule with 1 mg.

The sleep-onset claim needs exactly 1 mg per portion, so whatever the form, read the number per portion and not the product name.

How to choose a melatonin supplement

  1. Decide what you need it for. For falling asleep, pick exactly 1 mg per portion. For jet lag, 0.5 mg or more is enough.
  2. Read the melatonin amount per portion, not the pack size. "60 capsules" tells you nothing about the dose.
  3. Check the label timing and the warnings against your medicines and health.
  4. Look at the other ingredients. Valerian, lemon balm, saffron or magnesium change what you are taking.
  5. Choose a format you will use correctly: capsules or tablets for a fixed dose, drops or spray if you prefer, but check how many drops or sprays make 1 mg.
  6. Work out the price per day, not per pack.

Life Extension

Melatonin, 1 mg, 60 Capsules

1 mg/day · €0,22/day

€12,99
€13,49

FAQ

Is melatonin harmful?

At the label dose and for a short time, most adults tolerate it, and the common effects are headache, dizziness, nausea and sleepiness. It is not for children, pregnancy, breastfeeding, or driving afterwards, and some medicines need a doctor's approval first.

How much melatonin should I take?

For the EU sleep-onset claim, 1 mg close to bedtime. For jet lag, at least 0.5 mg close to bedtime. Stay within the daily dose on your label.

When should I take melatonin?

Close to bedtime. Our labels give 30 minutes to an hour before bed, depending on the brand.

Can children take melatonin?

Not unless a doctor says so. The labels of our products state that melatonin supplements are not for children.

Can I take melatonin every night?

Labels set a daily dose, but long-term data are lacking. If you find you need it every night, talk to a doctor about why.

Does melatonin help me stay asleep?

The authorised claims cover falling asleep faster and jet lag only.

Can I drive after taking melatonin?

No. Melatonin can cause drowsiness, and the labels say not to drive or operate heavy machinery after taking it. Take it only when you are ready to go to bed.

Is 3 mg better than 1 mg?

Not in the sense of an EU claim. The sleep-onset claim is authorised for exactly 1 mg per portion. A higher dose is just a different dose, with the same warnings, so ask a doctor before going beyond the label.

Sources

Content reviewed by Inese Kalniņa, dietitian.

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