Quick answer
- In the UK, melatonin is a prescription-only medicine. The MHRA treats any product containing it as a medicine, so melatonin sold as a supplement in the UK, including gummies on marketplaces, is illegal.
- In the EU, two claims are allowed: 1 mg close to bedtime reduces the time it takes to fall asleep, and 0.5 mg alleviates jet lag.
- In Spain, products must stay below 2 mg a day, which is why so many contain 1.9 or 1.95 mg. In Belgium and the Netherlands the limit is 0.3 mg; in the UK and Switzerland melatonin is prescription-only.
- The effect is modest: in a meta-analysis, people fell asleep about 7 minutes sooner. It helps falling asleep more than staying asleep.
- Not for children, pregnancy or breastfeeding without medical advice; it can interact with sedatives and blood thinners.
Key numbers
- United Kingdom
- Prescription-only medicine
- Licensed for short-term insomnia and jet lag in adults, and some children with ADHD.
- EU claim, falling asleep (not usable in the UK)
- 1 mg close to bedtime
- EU claim, jet lag
- 0.5 mg on travel days
- Spain
- below 2 mg/day as a supplement
- 2 mg or more is treated as a medicine (AEMPS).
- Belgium, Netherlands
- max. 0.3 mg/day
- Germany
- Legal status disputed
- Switzerland
- Prescription-only
What these terms mean: NRV upper levels (NHS, EFSA) maximum levels by country daily dose
How to choose
- Start with 1 mg or less, about 30 minutes before bed. Higher doses don't work better for most people.
- Choose immediate-release for falling asleep; prolonged-release is mainly studied in older adults and for staying asleep.
- Check combinations (B6, valerian, tryptophan, magnesium): the extras add cost but no authorised sleep claim.
- Avoid gummies in homes with children: they look like sweets.
- Use it for short periods (jet lag, shift changes). Persistent insomnia needs a doctor.
Melatonin formats compared
| Format | Typical dose | Good to know |
|---|---|---|
| Tablets, immediate release | 1–1.9 mg | Matches the authorised claim for falling asleep |
| Prolonged release (“retard”) | 1–1.98 mg | Spreads release over the night; mainly studied in older adults |
| Gummies | 1–1.9 mg | Look like sweets; keep away from children |
| Drops and sprays | 0.5–1.9 mg | Easy to take less; check mg per drop or spray |
| Sleep “complexes” | 1–1.95 mg plus plants or B6 | Only the melatonin has an authorised claim |
What the evidence says
Melatonin is a hormone your body releases in the evening; a supplement mainly shifts the timing of sleep. A 2013 meta-analysis found people with primary sleep disorders fell asleep about 7 minutes sooner and slept about 8 minutes longer, which fits the modest EU claim. It is most useful for jet lag and a delayed body clock.
Rules differ sharply across Europe, from a food supplement below 2 mg in Spain to a prescription medicine in the UK. Our melatonin guide has the full country table, and magnesium for sleep covers the most common alternative.
What the label may legally claim
Authorised claims (GB and EU registers)
- Contributes to the reduction of time taken to fall asleep (1 mg close to bedtime)
- Contributes to the alleviation of subjective feelings of jet lag (0.5 mg before bedtime on travel days)
Not authorised in GB or the EU
- Deeper or longer sleep
- Less anxiety
- Anti-ageing
How health claims work (UK & EU): health claims
Products we have checked
Label data checked by NutriMetrics for products sold in Spain and Germany. UK product checks are next. Sorted alphabetically, not ranked.
| Product | Per daily dose | Sold in | Label |
|---|---|---|---|
| Aquilea Melatonina 1,95 mg1 tablet before bed | 1.95 mg | Spain | Source |
| Aquilea Sueño1 tablet 30 min before bed | Not on the label | Spain | Source |
| Aquilea Sueño Forte1 tablet 30 min before bed | 1.95 mg | Spain | Source |
| Vicks / WICK (P&G) ZzzQuil Natura gummies (DE: ZzzQuil Goodnight)1 gummy 30 min before bed | 1 mg | Germany · Spain (not yet confirmed) | Source |
Who should be careful
- Children, pregnancy and breastfeeding: don't take it without medical advice.
- Medicines: it can interact with sedatives, blood thinners and some antidepressants. Avoid alcohol with it.
- Next-day drowsiness: don't drive or operate machinery if you feel sleepy.
FAQ
Can I buy melatonin in the UK without a prescription?
No. It is a prescription-only medicine, and the MHRA says any product containing melatonin must be licensed as a medicine. A GP or specialist can prescribe it when it is appropriate.
How much melatonin should I take?
In the UK, only on prescription, at the dose your prescriber sets. In the EU, the authorised claim is based on 1 mg taken close to bedtime; 0.5 mg for jet lag. In Spain, supplements must stay below 2 mg a day. Higher doses do not work better for most people.
Why do Spanish melatonin products contain 1.9 mg?
Because Spain's medicines agency treats melatonin at 2 mg a day or more as a medicine, so supplements stay just below that line.
Is melatonin legal in Germany?
Low-dose products are sold, but their status as food supplements is legally disputed and depends on court decisions. Higher-dose products are medicines.
Sources
- MHRA (August 2025) — Undeclared melatonin, a prescription-only medicine, found in kids' magnesium gummies
- DHSC — Great Britain nutrition and health claims (NHC) register
- European Commission — EU Register of nutrition and health claims (melatonin)
- Commission Regulation (EU) No 432/2012 — list of permitted health claims
- AEMPS — Withdrawal of a 3 mg melatonin supplement (medicine above 2 mg)
- Vanhee et al., Molecules 2025 — melatonin regulation in Europe
- Ferracioli-Oda E et al. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One, 2013
- PTA heute — How much melatonin is allowed in supplements? (Germany, 2022, German)
Information only, not medical advice. No product on this page is a paid placement.