Last update March 8, 2021

Brotizolam

Compatible

Safe substance and/or breastfeeding is the best option.

Short-acting benzodiazepine indicated in the treatment of insomnia.
Oral administration once a day.

It is excreted in breast milk in clinically insignificant amounts and no problems have been observed in infants whose mothers have taken it (Saito 2021, Nishimura 2021).

The occasional use and low doses of benzodiazepines are compatible with breastfeeding (Kelly 2012, Rubin 2004, Iqbal 2002, McElhatton 1994, Lee 1993, Kanto 1982).

It is advisable to choose a short-acting benzodiazepine and minimal effective dose as possible (Rowe 2013), especially in the neonatal period and in case of prematurity because they can accumulate in the infant during chronic use (Sachs 2013, Amir 2011).

It is advisable to monitor drowsiness and adequate feeding of the infant.
It is not recommended to share a bed (co-sleeping, bed-sharing) with the baby if this drug is being taken, due to increased risk of asphyxia or sudden infant death (UNICEF UK 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF UK 2006).

Alternatives

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

Brotizolam in other languages or writings:

Group

Brotizolam belongs to this group or family:

Tradenames

Main tradenames from several countries containing Brotizolam in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 70 %
Molecular weight 394 daltons
Protein Binding 89 - 95 %
VD 0.63 l/Kg
pKa 18.49 -
Tmax 0.75 ± 0.2 hours
T½ 4.4 (3 - 8) hours
M/P ratio 0.12 -
Theoretical Dose 0.0001 mg/Kg/d
Relative Dose 2.3 %

References

  1. Saito J, Tachibana Y, Wada YS, Yakuwa N, Kawasaki H, Suzuki T, Sago H, Yamatani A, Murashima A. Transfer of brotizolam, periciazine, and sulpiride in cord blood and breast milk, and alprazolam in breast milk: a case report. J Pharm Health Care Sci. 2022 Apr 1;8(1):10. Consulted on May 24, 2022 Abstract Full text (link to original source)
  2. Nishimura A, Furugen A, Umazume T, Kitamura S, Soma M, Noshiro K, Takekuma Y, Sugawara M, Iseki K, Kobayashi M. Benzodiazepine Concentrations in the Breast milk and Plasma of Nursing Mothers: Estimation of Relative Infant Dose. Breastfeed Med. 2021 Jan 15. Abstract
  3. Saito J, Ishii M, Miura Y, Yakuwa N, Kawasaki H, Suzuki T, Yamatani A, Sago H, Tachibana Y, Murashima A. Brotizolam During Pregnancy and Lactation: Brotizolam Levels in Maternal Serum, Cord Blood, Breast Milk, and Neonatal Serum. Breastfeed Med. 2021 Mar 5. Abstract
  4. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  5. 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)
  6. 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)
  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. 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)
  9. 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)
  10. 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)
  11. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  12. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  13. 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)
  14. 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)
  15. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  16. 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
  17. 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)
  18. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  19. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  20. 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)
  21. 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

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