Last update May 6, 2022

Melatonin

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Hormone secreted by Pineal gland which exerts its function by regulating the Circadian pattern of sleeping. It is naturally found in the mother's milk. (Cohen 2012)

Melatonin has a circadian rhythm. The level of Melatonin in the plasma and breast milk, nearly undetectable during the day, increases by night (Gombert 2021,Italianer 2020, Katzer 2016, Cohen 2012, Illnerová 1993). It is believed that this helps to organize the sleep - awake cycle in breastfed newborns and infants. (Sánchez 2011). The older the mother, the less melatonin is in breast milk (Gila 2020). Melatonin levels are maintained in frozen breast milk. (Molad 2019)

It has antioxidant and anti-inflammatory properties (Gombert 2021,Tan 2014), and, it is found in many foods, either vegetable or animal in origin (meat, fish), eggs, wine and beer. (Tan 2014)

On latest update, no relevant published data related to breastfeeding were found.

Known side-effects of melatonin are mild and few (Andersen 2016). It is being used for co-treatment of several conditions in chidren, newborn infants and prematures (Gitto 2013, Merchant 2013, Sánchez 2011) with good tolerance in spite of higher doses than those excreted in the breast milk.

Its very low oral bioavailability (EMA 2012, Fourtillan 2000, DeMuro 2000) minimizes the passage into plasma of the infant from ingested breast milk, except in the premature and in the immediate neonatal period in which there may be greater intestinal permeability.

Expert authors consider the use of this medication possible during breastfeeding. (Hale, LactMed, Vine 2021)

Alternatives

We do not have alternatives for Melatonin.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Melatonin is also known as


Melatonin in other languages or writings:

Group

Melatonin belongs to this group or family:

Tradenames

Main tradenames from several countries containing Melatonin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 16 (1 -37) %
Molecular weight 232 daltons
Protein Binding 50 - 60 %
pKa 15.8 -
Tmax 0.5 - 2 hours
0.6 - 0.7 hours
M/P ratio 0.4 - 0.8 -

References

  1. Vine T, Brown GM, Frey BN. Melatonin use during pregnancy and lactation: A scoping review of human studies. Braz J Psychiatry. 2021 Nov 1. pii: S1516-44462021005028202. Abstract
  2. Gombert M, Codoñer-Franch P. Melatonin in Early Nutrition: Long-Term Effects on Cardiovascular System. Int J Mol Sci. 2021 Jun 24;22(13). pii: 6809. Abstract
  3. Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8). pii: E2328. Abstract
  4. Gila-Díaz A, Herranz Carrillo G, Cañas S, Saenz de Pipaón M, Martínez-Orgado JA, Rodríguez-Rodríguez P, López de Pablo ÁL, Martin-Cabrejas MA, Ramiro-Cortijo D, Arribas SM. Influence of Maternal Age and Gestational Age on Breast Milk Antioxidants During the First Month of Lactation. Nutrients. 2020 Aug 25;12(9). pii: E2569. Abstract
  5. Molad M, Ashkenazi L, Gover A, Lavie-Nevo K, Zaltsberg-Barak T, Shaked-Mishan P, Soloveichik M, Kessel I, Rotschild A, Etzioni T. Melatonin Stability in Human Milk. Breastfeed Med. 2019 Nov;14(9):680-682. Abstract
  6. Katzer D, Pauli L, Mueller A, Reutter H, Reinsberg J, Fimmers R, Bartmann P, Bagci S. Melatonin Concentrations and Antioxidative Capacity of Human Breast Milk According to Gestational Age and the Time of Day. J Hum Lact. 2016 Nov;32(4):NP105-NP110. Abstract
  7. Andersen LP, Gögenur I, Rosenberg J, Reiter RJ. The Safety of Melatonin in Humans. Clin Drug Investig. 2016 Mar;36(3):169-75. Abstract
  8. Tan DX, Zanghi BM, Manchester LC, Reiter RJ. Melatonin identified in meats and other food stuffs: potentially nutritional impact. J Pineal Res. 2014 Abstract
  9. Merchant NM, Azzopardi DV, Hawwa AF, McElnay JC, Middleton B, Arendt J, Arichi T, Gressens P, Edwards AD. Pharmacokinetics of melatonin in preterm infants. Br J Clin Pharmacol. 2013 Abstract
  10. Gitto E, Marseglia L, Manti S, D'Angelo G, Barberi I, Salpietro C, Reiter RJ. Protective role of melatonin in neonatal diseases. Oxid Med Cell Longev. 2013 Abstract
  11. EMA. Melatonina. Ficha técnica. 2012 Full text (in our servers)
  12. Cohen Engler A, Hadash A, Shehadeh N, Pillar G. Breastfeeding may improve nocturnal sleep and reduce infantile colic: potential role of breast milk melatonin. Eur J Pediatr. 2012 Abstract
  13. EMA. Melatonin. Drug Summary. 2012 Full text (in our servers)
  14. Sánchez-Barceló EJ, Mediavilla MD, Reiter RJ. Clinical uses of melatonin in pediatrics. Int J Pediatr. 2011 Abstract
  15. Fourtillan JB, Brisson AM, Gobin P, Ingrand I, Decourt JP, Girault J. Bioavailability of melatonin in humans after day-time administration of D(7) melatonin. Biopharm Drug Dispos. 2000 Abstract
  16. DeMuro RL, Nafziger AN, Blask DE, Menhinick AM, Bertino JS Jr. The absolute bioavailability of oral melatonin. J Clin Pharmacol. 2000 Abstract
  17. Illnerová H, Buresová M, Presl J. Melatonin rhythm in human milk. J Clin Endocrinol Metab. 1993 Abstract

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