Last update Nov. 23, 2023

Lemborexant

Decreased level of risk

New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment., is now set to Safe. Compatible. Minimal risk for breastfeeding and infant.

Level of risk reviewed on Nov. 23, 2023

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Lemborexant is a dual orexin receptor antagonist used to treat insomnia in adults. Oral administration in one dose at bedtime.

At the date of the last update we did not find any published data on its excretion in breast milk.

Its pharmacokinetic data (high percentage of binding to plasma proteins, very large volume of distribution and moderately high molecular weight) explain the minimal passage into breast milk observed. (Rawal 2023, Saito 2023)

Infants exposed to this drug through breast milk should be monitored for excessive sedation and/or poor feeding. (FDA 2019)

Due to its sedative effect, it is not recommended to share a bed with the baby if this drug is being taken. (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)

Alternatives

  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Zolpidem Tartrate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

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Other names

Lemborexant in other languages or writings:

Group

Lemborexant belongs to this group or family:

Tradenames

Main tradenames from several countries containing Lemborexant in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 410 daltons
Protein Binding 87 - 94 %
VD 28.1 l/Kg
pKa 12.12 -
Tmax 1 - 3 hours
T½ 17 - 19 hours
M/P ratio ≈ 0.34 - 0.45 -
Theoretical Dose 0.0003 - 0.002 mg/Kg/d
Relative Dose 0.16 - 1.14 %

References

  1. Rawal S, Brimhall D, Aluri J, Cheng JY, Hall N, Moline M. Lemborexant levels in breast milk after single doses in healthy, lactating women. Br J Clin Pharmacol. 2023 Aug 10. Consulted on Nov. 23, 2023 Abstract Full text (link to original source)
  2. Saito J, Ishii M, Sandaiji N, Yamaguchi K, Suzuki T, Yakuwa N, Yamatani A, Tachibana Y, Sago H, Murashima A. Lemborexant levels in maternal serum, cord blood, and breast milk during pregnancy and lactation: A case report. Psychiatry Clin Neurosci Rep 2023;2:e62. doi:10.1002/pcn5.62 Consulted on Nov. 23, 2023 Abstract Full text (link to original source)
  3. Eisai. Lemborexant (Dayvigo). Drug Summary. 2020 Full text (in our servers)
  4. FDA. Lemborexant (Dayvigo). Drug Summary. 2019 Full text (in our servers)
  5. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  6. UNICEF. Ball H, Blair PS. (For UNICEF UK). Caring for your baby at night. Health professional´s guide. 2017 Full text (link to original source) Full text (in our servers)
  7. UNICEF UK. Statement on co-sleeping following publication of new NICE postnatal guidance. Infosheet. 2014 Full text (link to original source) Full text (in our servers)
  8. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. None 2013 Full text (link to original source) Full text (in our servers)
  9. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  10. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008 Abstract Full text (link to original source) Full text (in our servers)
  11. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  12. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)

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