Last update May 18, 2022

6-Azamianserin

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Mirtazapine is a tetracyclic antidepressant with sedative action, analog of mianserin, used in the treatment of major depression and, off-label, to treat insomnia and increase appetite. Oral administration in one or two daily doses.

It is excreted into breast milk in a clinically non-significant amount. (Tonn 2009, Klier 2007, Kristensen 2007, Aichhorn 2004)

Plasma level of breastfed infants from treated mothers with Mirtazapine are usually undetectable or very low (Klier 2007, Kristensen 2007, Aichhorn 2004), with some exceptions. (Tonn 2009)

Not significant clinically based side-effects in the infants both at short and long-term have been observed. (Uguz 2019, Tonn 2009, Klier 2007, Kristensen 2007, Aichhorn 2004) 

Isolated cases of galactorrhea (Schroeder 2013, Lynch 2004) and decreased prolactin (Schüle 2002) have been reported.

Expert authors consider the use of this medication possible during breastfeeding. (Hale, LactMed, Uguz 2021, Schaefer 2015, Berle 2011, Davanzo 2011, Patil 2011, Lanza 2009)

The poor extrauterine adaptation that may appear in neonates just after birth when the pregnant woman has been treated with selective reuptake-inhibitors of Serotonin like Venlafaxine or Mirtazapine, is seen to be mild if the baby is breastfed. (Smit 2015, Kieviet 2013, Hale 2010)

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)

Due to the sedative action on the mother and because there is less published experience than with other antidepressant drugs, known safer alternatives might be preferable, especially during the neonatal period and in the event of prematurity.


See below the information of these related products:

  • Maternal Depression (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Mianserin Hydrochloride (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

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.

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

6-Azamianserin is also known as Mirtazapine. Here it is a list of alternative known names::


6-Azamianserin in other languages or writings:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 265 daltons
Protein Binding 85 %
VD 1.5 ± 0.6 l/Kg
pKa 6.67 -
Tmax 2 hours
20 - 40 hours
M/P ratio 0.8 -
Theoretical Dose 0.005 - 0.02 mg/Kg/d
Relative Dose 0.6 - 4.4 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. 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
  4. Uguz F. Short-Term Safety of Paroxetine Plus Low-Dose Mirtazapine During Lactation. Breastfeed Med. 2019 Mar;14(2):131-132. Abstract
  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. Smit M, Wennink HJ, Heres MM, Dolman KK, Honig A. Mirtazapine in pregnancy and lactation: data from a case series. J Clin Psychopharmacol. 2015 Abstract
  8. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  9. 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)
  10. Schroeder K, Huber CG, Jahn H. Mirtazapine-induced galactorrhea: a case report. J Neuropsychiatry Clin Neurosci. 2013 Abstract Full text (link to original source) Full text (in our servers)
  11. 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)
  12. Kieviet N, Dolman KM, Honig A. The use of psychotropic medication during pregnancy: how about the newborn? Neuropsychiatr Dis Treat. 2013 Abstract Full text (link to original source) Full text (in our servers)
  13. AEMPS. Mirtazapina. Ficha técnica. 2013 Full text (in our servers)
  14. Pfizer. Mirtazapine. Product Monograph. 2012 Full text (in our servers)
  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. Berle JO, Spigset O. Antidepressant Use During Breastfeeding. Curr Womens Health Rev. 2011 Abstract Full text (link to original source) Full text (in our servers)
  17. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  18. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  19. Hale TW, Kendall-Tackett K, Cong Z, Votta R, McCurdy F. Discontinuation syndrome in newborns whose mothers took antidepressants while pregnant or breastfeeding. Breastfeed Med. 2010 Abstract
  20. Tonn P, Reuter SC, Hiemke C, Dahmen N. High mirtazapine plasma levels in infant after breast feeding: case report and review of the literature. J Clin Psychopharmacol. 2009 Abstract
  21. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009 Abstract Full text (link to original source) Full text (in our servers)
  22. 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)
  23. 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)
  24. Kristensen JH, Ilett KF, Rampono J, Kohan R, Hackett LP. Transfer of the antidepressant mirtazapine into breast milk. Br J Clin Pharmacol. 2007 Abstract Full text (link to original source) Full text (in our servers)
  25. Klier CM, Mossaheb N, Lee A, Zernig G. Mirtazapine and breastfeeding: maternal and infant plasma levels. Am J Psychiatry. 2007 Abstract Full text (link to original source) Full text (in our servers)
  26. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  27. Aichhorn W, Whitworth AB, Weiss U, Stuppaeck C. Mirtazapine and breast-feeding. Am J Psychiatry. 2004 Abstract Full text (link to original source) Full text (in our servers)
  28. Lynch A, Madjlessi A. [Gynecomastia-galactorrhea during treatment with mirtazapine]. Presse Med. 2004 Apr 10;33(7):458. French. No abstract available. Abstract
  29. Schüle C, Baghai T, Bidlingmaier M, Strasburger C, Laakmann G. Endocrinological effects of mirtazapine in healthy volunteers. Prog Neuropsychopharmacol Biol Psychiatry. 2002 Abstract

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