Last update Dec. 22, 2021

Lormetazepam

Compatible

Safe product and/or breastfeeding is the best option.

Short-acting benzodiazepine. Used as a hypnotic in insomnia. Once per day (at night).

It is excreted in breast milk in clinically insignificant amounts (Lemmer 2007, Humpel 1982) and no problems have been observed in infants whose mothers took it (Humpel 1982). The levels in plasma of said infants were undetectable or very low. (Humpel 1982)

The occasional and low-dose use of benzodiazepines is compatible with breastfeeding. (Kelly 2012, Rubin 2004, Iqbal 2002, Hägg 2000, McElhatton 1994, Lee 1993, Kanto 1982) 

Choose short-acting benzodiazepines and use the lowest effective dose (Rowe 2013), especially during the neonatal period and in prematurity, as they can accumulate in the infant during chronic use. (Sachs 2013)

It is advisable to monitor drowsiness and adequate feeding of the infant. Bed-sharing with the baby is not recommended if this medicine is being taken due to increased risk of suffocation or sudden infant death. (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)

Alternatives

  • Lorazepam (Safe product and/or breastfeeding is the best option.)
  • Midazolam (Safe product and/or breastfeeding is the best option.)
  • Oxazepam (Safe product and/or breastfeeding is the best option.)

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

Lormetazepam in other languages or writings:

Group

Lormetazepam belongs to this group or family:

Tradenames

Main tradenames from several countries containing Lormetazepam in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 %
Molecular weight 335 daltons
Protein Binding 85 - 90 %
pKa 10.68 -
Tmax 1.5 hours
T½ 11- 12 hours
M/P ratio 0.06 - 0.1 -
Theoretical Dose 0.00003 mg/Kg/d
Relative Dose 0.09 - 0.2 %

References

  1. (ABM): Blair PS, Ball HL, McKenna JJ, Feldman-Winter L, Marinelli KA, Bartick MC; Academy of Breastfeeding Medicine.. Bedsharing and Breastfeeding: The Academy of Breastfeeding Medicine Protocol #6, Revision 2019. Breastfeed Med. 2020 Jan;15(1):5-16. Abstract Full text (link to original source) Full text (in our servers)
  2. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  3. 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)
  4. 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)
  5. 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)
  6. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  7. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  8. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  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. Lemmer P, Schneider S, Mühe A, Wennig R. Quantification of lorazepam and lormetazepam in human breast milk using GC-MS in the negative chemical ionization mode. J Anal Toxicol. 2007 Abstract
  13. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  14. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  15. Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49. Review. Abstract Full text (in our servers)
  16. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  17. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  18. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993 Jul;48(7):616-25. Review. Abstract Full text (link to original source) Full text (in our servers)
  19. Kanto JH. Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations. Drugs. 1982 May;23(5):354-80. Review. Abstract
  20. Hümpel M, Stoppelli I, Milia S, Rainer E. Pharmacokinetics and biotransformation of the new benzodiazepine, lormetazepam, in man. III. Repeated administration and transfer to neonates via breast milk. Eur J Clin Pharmacol. 1982 Abstract

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