Last update Aug. 19, 2021

N05CD08

Compatible

Safe product and/or breastfeeding is the best option.

Short-acting benzodiazepine. Indicated for the treatment of acute seizures, insomnia and pre-surgical sedation and induction of anesthesia.
Oral or intravenous administration, generally in a single dose. In insomnia, a single daily dose.

It is excreted in breast milk in undetectable or clinically insignificant amounts (Nitsun 2006, Koitabashi 1997, Matheson 1990) and no problems have been observed in infants whose mothers were taking it, including during the neonatal period (Kelly 2012).

The administration of a dose of midazolam after caesarean section does not interfere with the initiation and duration of lactation (Suppa 2012).

Various medical societies and expert consensus consider the use of this medication safe during breastfeeding. Breastfeeding can be resumed as soon as the mother is awake and healthy. (Briggs 2017, Hale 2017 p655, Reece 2017, Schaefer 2007 p634, Nitsun 2006, Spigset 1994, Lee 1993).

It does not seem justifiable to wait 4 hours to breastfeed after the last dose of midazolam as recommended by some authors (Shergill 2012, Vargo 2012, Matheson 1990).

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

  • Dexmedetomidine Hydrochloride (Safe product and/or breastfeeding is the best option.)
  • Methohexital (Safe product and/or breastfeeding is the best option.)
  • Zaleplon (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Zolpidem Tartrate (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

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

N05CD08 is Midazolam in ATC Code/s.

Is written in other languages:

N05CD08 is also known as

Group

N05CD08 belongs to this group or family:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 44 %
Molecular weight 326 daltons
Protein Binding 98 %
VD 1 - 3.1 l/Kg
Tmax 0.3 - 0.8 hours
1.5 - 2.5 hours
M/P ratio 0.15 -
Theoretical Dose 0.0014 mg/Kg/d
Relative Dose 1 - 2 %
Ped.Relat.Dose 0.1 - 1.4 %

References

  1. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  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. Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeed Med. 2017 Nov;12(9):500-506. Full text (link to original source) Full text (in our servers)
  4. 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)
  5. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  6. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  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. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  9. 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)
  10. 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)
  11. ASGE Standard of Practice Committee., Shergill AK, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Evans JA, Early DS, Fanelli RD, Fisher DA, Foley KQ, Fukami N, Hwang JH, Jain R, Jue TL, Khan KM, Lightdale J, Pasha SF, Sharaf RN, Dominitz JA, Cash BD. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc. 2012 Jul;76(1):18-24. Abstract Full text (link to original source) Full text (in our servers)
  12. AGA - American Association for the Study of Liver Diseases; American College of Gastroenterology; American Gastroenterological Association Institute; American Society for Gastrointestinal Endoscopy; Society for Gastroenterology Nurses and Associates, Vargo JJ, DeLegge MH, Feld AD, Gerstenberger PD, Kwo PY, Lightdale JR, Nuccio S, Rex DK, Schiller LR. Multisociety sedation curriculum for gastrointestinal endoscopy. Gastroenterology. 2012 Jul;143(1):e18-41. Abstract Full text (link to original source) Full text (in our servers)
  13. Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as \preventive\ pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Abstract Full text (link to original source) Full text (in our servers)
  14. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  15. 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)
  16. 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)
  17. 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)
  18. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  19. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  20. Nitsun M, Szokol JW, Saleh HJ, Murphy GS, Vender JS, Luong L, Raikoff K, Avram MJ. Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk. Clin Pharmacol Ther. 2006 Abstract
  21. Nice FJ, De Eugenio D, Dimino TA, Freeny IC, Rovnack MB, Gromelski JS. Medications and Breast-Feeding: A Guide for Pharmacists, Pharmacy Technicians, and Other Healthcare Professionals. Part I. J Pharm Technol 2004;20:17-27. doi: 10.1177/875512250402000106.
  22. 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
  23. 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)
  24. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  25. Koitabashi T, Satoh N, Takino Y. Intravenous midazolam passage into breast milk. J Anesth. 1997 Abstract
  26. Spigset O. Anaesthetic agents and excretion in breast milk. Acta Anaesthesiol Scand. 1994 Abstract
  27. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  28. 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)
  29. Matheson I, Lunde PK, Bredesen JE. Midazolam and nitrazepam in the maternity ward: milk concentrations and clinical effects. Br J Clin Pharmacol. 1990 Abstract Full text (link to original source) Full text (in our servers)
  30. Heizmann P, Eckert M, Ziegler WH. Pharmacokinetics and bioavailability of midazolam in man. Br J Clin Pharmacol. 1983 Abstract
  31. 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
  32. Allonen H, Ziegler G, Klotz U. Midazolam kinetics. Clin Pharmacol Ther. 1981 Abstract

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