Mélatonine in food supplements

2,291 supplements declared in France contain Mélatonine as a substance or active ingredient.

In cosmetics: MELATONIN.

Other names in the Compl'Alim list: Melatonin.

ANSES advises against melatonin food supplements for pregnant or breastfeeding women, children and adolescents, people with an inflammatory or autoimmune disease, and before an activity that requires sustained alertness. It asks for medical advice for people with epilepsy, asthma, or mood, behaviour or personality disorders, and for people taking medication. Its experts recommend occasional use and no more than 2 mg a day. The opinion is based on 90 adverse-effect reports received from 2009 to May 2017.

The BfR considers that children and adolescents, pregnant or breastfeeding women, women wishing to conceive, people with reduced liver or kidney function, and people with an autoimmune disease or epilepsy should not take melatonin supplements without medical supervision.

Uses

• Derivatives and analogs of melatonin are being used in the development of preventive therapies of Alzheimer's disease.

• Melatonin drugs and supplements have use in treating insomnia, sleep disorders and jet lag; treatment for reducing pain of "cluster headaches; some evidence that melatonin might improve the effectiveness of cancer drugs used to fight tumors in the breast, lung, kidney, liver, pancreas, stomach and colon.

Use classification

• Cosmetics -> Antioxidant

A molecule found naturally in plants or organisms; in a supplement it may be extracted from them, made by fermentation or synthesised: the declaration does not say which.

Basis: one CosIngThe European Commission's database of cosmetic ingredients. CAS and natural occurrence recorded in Wikidata (LOTUS database).

Natural occurrence recorded in Wikidata (LOTUS database): 84 taxa; examples: Solanum lycopersicum, Solanum tuberosum, Scutellaria baicalensis, Scutellaria lateriflora, Angelica sinensis.

Manufacturing

• Formed from serotonin (5-HT).

• Melatonin is synthesized endogenously by the pinealocytes of the pineal gland. The essential amino acid L-tryptophan is a precursor in the synthesis of melatonin. In this synthesis, L-tryptophan first gets metabolized to 5-hydroxytryptophan from which 5-hydroxytryptamine, also known as serotonin, is made. 5-hydroxytryptamine is converted to melatonin in a two-step process, occurring mainly in the pineal gland.

Appearance

• Pale yellow leaflets from benzene

• White-cream to yellowish crystalline powder

Other names: melatonina (Spanish), melatonina (Italian), melatonina (Portuguese).

Health claims register (European Union): 2 authorised and 1 refused claim(s) for this substance.

• « Melatonin contributes to the alleviation of subjective feelings of jet lag »
  Conditions: The claim may be used only for food which contains at least 0,5 mg of melatonin per quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a minimum intake of 0,5 mg to be taken close to bedtime on the first day of travel and on the following few days after arrival at the destination.
• « Melatonin contributes to the reduction of time taken to fall asleep »
  Conditions: The claim may be used only for food which contains 1 mg of melatonin per quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained by consuming 1 mg of melatonin close to bedtime.

Compl'Alim ingredient list (France): listed.

Canada, licensed natural health products (LNHPD): 70 products.

United States, supplement labels (DSLD; supplements need no prior approval): 1668 products.

Poland, notified supplements: 2 products.

Official warnings (Health Canada)

MELATONIN - Oral

Cautions and warnings

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).

When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).

When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).

Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).

Contraindications

Do not use if you are pregnant or breastfeeding (IOM 2004).

Known adverse reactions

Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).

Health Canada monograph dated 19 December 2025

MELATONIN - Sublingual

Cautions and warnings

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).

When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).

When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).

Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).

Contraindications

Do not use if you are pregnant or breastfeeding (IOM 2004).

Known adverse reactions

Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).

Health Canada monograph dated 19 December 2025