Last update June 18, 2022

N06AB06

Compatible

Safe substance and/or breastfeeding is the best option.

SSRI antidepressant with properties and uses similar to those of fluoxetine. Single daily dose oral administration.

It is excreted in human milk in an undetectable or clinically insignificant amount. (Schoretsanitis 2019, Pogliani 2019, Weisskopf 2017, Salazar 2016, Weissman 2004, Berle 2004, Stowe 2003 and 1997, Hendrick 2001, Dodd 2000, Kristensen 1998, Altshuler 1995)

Plasma levels in infants whose mothers take sertraline are usually very low or below the detection limit. (Wisner 2006, Stowe 2003 and 1997, Hendrick 2001, Dodd 2001, Epperson 2001 and 1997, Wisner 1998, Kristensen 1998, Mammen 1997, Altshuler 1995)

No short or long term clinical or developmental repercussions have been observed. (Pogliani 2019, Stowe 2003 and 1997, Hendrick 2003 and 2001, Kristensen 1998, Mammen 1997, Altshuler 1995)

There may be transient problems during the immediate neonatal period, such as antidepressant discontinuation syndrome or serotonin hyperstimulation, in term or preterm infants born with high plasma levels because their mothers were taking sertraline during pregnancy. (Müller 2013, Hale 2010)

Although less commonly than other antidepressants, sertraline can cause galactorrhea (Nebhinani 2013, Lesaca 1996), with (Petit 2003) or without (Trenque 2011, Sagud 2002, Gordon 1998) hyperprolactinaemia. There may also be a temporary decrease in milk production that improves with good hydration. (Holland 2000)

It is probably the safest antidepressant during breastfeeding.

Various medical societies and expert consensus consider the use of this medication safe during breastfeeding. (Hale, LactMed, Uguz 2021, Molenaar 2018, Mcallister 2017, Pinheiro 2015, Sriraman 2015, Orsolini 2015, Davanzo 2014 and 2011, Rowe 2013, Berle 2011 , Patil 2011, Amir 2011, Lanza 2009, ABM 2008, Gentile 2005, Weissman 2004, Rubin 2004, Gjerdingen 2003, Wisner 2002 and 1996, Nordeng 2001)

Women suffering from depression during pregnancy need more breastfeeding support due to their increased risk of problems and of early cessation of breastfeeding. (Grzeskowiak 2018, Leggett 2017, Venkatesh 2017, Gorman 2012)


See below the information of this related product:

  • Maternal Depression (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

We do not have alternatives for N06AB06 since it is relatively safe.

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.

Tradenames

Main tradenames from several countries containing N06AB06 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 343 daltons
Protein Binding 98 %
VD 20 l/Kg
Tmax 4.5 - 8.4 hours
24 - 26 hours
M/P ratio 0.9 -
Theoretical Dose 0.00002 mg/Kg/d
Relative Dose 0.003 %

References

  1. 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 April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 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. Pogliani L, Baldelli S, Cattaneo D, Pileri P, Clementi E, Cetin I, Zuccotti G. Selective serotonin reuptake inhibitors' passage into human milk of lactating women. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3020-3025. Abstract
  5. Schoretsanitis G, Augustin M, Saßmannshausen H, Franz C, Gründer G, Paulzen M. Antidepressants in breast milk; comparative analysis of excretion ratios. Arch Womens Ment Health. 2019 Jun;22(3):383-390. Abstract
  6. Rybakowski J, Cubała WJ, Gałecki P, Rymaszewska J, Samochowiec J, Szulc A, Dudek D. Recommendations of the Polish Psychiatric Association regarding the treatment of affective disorders in women of childbearing age. Part II: Bipolar disorder. Psychiatr Pol. 2019 Apr 30;53(2):263-276. Abstract Full text (link to original source)
  7. Molenaar NM, Kamperman AM, Boyce P, Bergink V. Guidelines on treatment of perinatal depression with antidepressants: An international review. Aust N Z J Psychiatry. 2018 Apr;52(4):320-327. Abstract
  8. Grzeskowiak LE, Leggett C, Costi L, Roberts CT, Amir LH. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: a retrospective cohort study. Br J Clin Pharmacol. 2018 Jun;84(6):1373-1379. Abstract Full text (link to original source)
  9. Leggett C, Costi L, Morrison JL, Clifton VL, Grzeskowiak LE. Antidepressant Use in Late Gestation and Breastfeeding Rates at Discharge from Hospital. J Hum Lact. 2017 Nov;33(4):701-709. Abstract
  10. Venkatesh KK, Castro VM, Perlis RH, Kaimal AJ. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: an observational cohort study. J Perinatol. 2017 Sep;37(9):1003-1009. Abstract
  11. Weisskopf E, Panchaud A, Nguyen KA, Grosjean D, Hascoët JM, Csajka C, Eap CB, Ansermot N; collaborators of the SSRI-Breast Milk study.. Simultaneous determination of selective serotonin reuptake inhibitors and their main metabolites in human breast milk by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 1;1057:101-109. Abstract
  12. McAllister-Williams RH, Baldwin DS, Cantwell R, Easter A, Gilvarry E, Glover V, Green L, Gregoire A, Howard LM, Jones I, Khalifeh H, Lingford-Hughes A, McDonald E, Micali N, Pariante CM, Peters L, Roberts A, Smith NC, Taylor D, Wieck A, Yates LM, Young AH; et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017 May;31(5):519-552. Abstract
  13. Salazar FR, D'Avila FB, de Oliveira MH, Ferreira PL, Bergold AM. Development and validation of a bioanalytical method for five antidepressants in human milk by LC-MS. J Pharm Biomed Anal. 2016 Sep 10;129:502-508. Abstract
  14. Larsen ER, Damkier P, Pedersen LH, Fenger-Gron J, Mikkelsen RL, Nielsen RE, Linde VJ, Knudsen HE, Skaarup L, Videbech P. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015 Abstract
  15. Sriraman NK, Melvin K, Meltzer-Brody S. ABM Clinical Protocol #18: Use of Antidepressants in Breastfeeding Mothers. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  16. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015 Jan;30(1):4-20. Abstract
  17. Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014 Abstract
  18. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  19. Nebhinani N. Sertraline-induced galactorrhea: case report and review of cases reported with other SSRIs. Gen Hosp Psychiatry. 2013 Abstract
  20. Müller MJ, Preuß C, Paul T, Streit F, Brandhorst G, Seeliger S. Serotonergic overstimulation in a preterm infant after sertraline intake via breastmilk. Breastfeed Med. 2013 Abstract
  21. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  22. Trenque T, Herlem E, Auriche P, Dramé M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011 Abstract
  23. 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)
  24. 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)
  25. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  26. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  27. 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
  28. 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)
  29. Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #18: use of antidepressants in nursing mothers. Breastfeed Med. 2008 Abstract Full text (link to original source) Full text (in our servers)
  30. Wisner KL, Hanusa BH, Perel JM, Peindl KS, Piontek CM, Sit DK, Findling RL, Moses-Kolko EL. Postpartum depression: a randomized trial of sertraline versus nortriptyline. J Clin Psychopharmacol. 2006 Abstract
  31. Gentile S. The safety of newer antidepressants in pregnancy and breastfeeding. Drug Saf. 2005 Abstract
  32. 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
  33. Berle JØ, Steen VM, Aamo TO, Breilid H, Zahlsen K, Spigset O. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome p450 genotypes. J Clin Psychiatry. 2004 Abstract
  34. Weissman AM, Levy BT, Hartz AJ, Bentler S, Donohue M, Ellingrod VL, Wisner KL. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004 Abstract Full text (link to original source) Full text (in our servers)
  35. Gjerdingen D. The effectiveness of various postpartum depression treatments and the impact of antidepressant drugs on nursing infants. J Am Board Fam Pract. 2003 Abstract Full text (link to original source) Full text (in our servers)
  36. Hendrick V, Smith LM, Hwang S, Altshuler LL, Haynes D. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003 Abstract
  37. Stowe ZN, Hostetter AL, Owens MJ, Ritchie JC, Sternberg K, Cohen LS, Nemeroff CB. The pharmacokinetics of sertraline excretion into human breast milk: determinants of infant serum concentrations. J Clin Psychiatry. 2003 Abstract
  38. Petit A, Piednoir D, Germain ML, Trenque T. [Drug-induced hyperprolactinemia: a case-non-case study from the national pharmacovigilance database]. Therapie. 2003 Abstract
  39. Sagud M, Pivac N, Mück-Seler D, Jakovljević M, Mihaljević-Peles A, Korsić M. Effects of sertraline treatment on plasma cortisol, prolactin and thyroid hormones in female depressed patients. Neuropsychobiology. 2002 Abstract
  40. Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Abstract
  41. DeVane CL, Liston HL, Markowitz JS. Clinical pharmacokinetics of sertraline. Clin Pharmacokinet. 2002 Abstract
  42. Nordeng H, Bergsholm YK, Bøhler E, Spigset O. Overgang av selektive serotoninreopptakshemmere til morsmelk \ [The transfer of selective serotonin reuptake inhibitors to human milk]. Tidsskr Nor Laegeforen. 2001 Abstract Full text (link to original source) Full text (in our servers)
  43. Dodd S, Stocky A, Buist A, Burrows GD, Norman TR. Sertraline analysis in the plasma of breast-fed infants. Aust N Z J Psychiatry. 2001 Abstract
  44. Hendrick V, Fukuchi A, Altshuler L, Widawski M, Wertheimer A, Brunhuber MV. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001 Abstract Full text (link to original source) Full text (in our servers)
  45. Epperson N, Czarkowski KA, Ward-O'Brien D, Weiss E, Gueorguieva R, Jatlow P, Anderson GM. Maternal sertraline treatment and serotonin transport in breast-feeding mother-infant pairs. Am J Psychiatry. 2001 Abstract Full text (in our servers)
  46. Dodd S, Stocky A, Buist A, Burrows GD, Maguire K, Norman TR. Sertraline in paired blood plasma and breast-milk samples from nursing mothers. Hum Psychopharmacol. 2000 Abstract
  47. Holland D. An observation of the effect of sertraline on breast milk supply. Aust N Z J Psychiatry. 2000 Abstract
  48. Kristensen JH, Ilett KF, Dusci LJ, Hackett LP, Yapp P, Wojnar-Horton RE, Roberts MJ, Paech M. Distribution and excretion of sertraline and N-desmethylsertraline in human milk. Br J Clin Pharmacol. 1998 Abstract Full text (in our servers)
  49. Gordon C, Whale R, Cowen PJ. Sertraline treatment does not increase plasma prolactin levels in healthy subjects. Psychopharmacology (Berl). 1998 Abstract
  50. Wisner KL, Perel JM, Blumer J. Serum sertraline and N-desmethylsertraline levels in breast-feeding mother-infant pairs. Am J Psychiatry. 1998 Abstract Full text (in our servers)
  51. Stowe ZN, Owens MJ, Landry JC, Kilts CD, Ely T, Llewellyn A, Nemeroff CB. Sertraline and desmethylsertraline in human breast milk and nursing infants. Am J Psychiatry. 1997 Abstract Full text (in our servers)
  52. Epperson CN, Anderson GM, McDougle CJ. Sertraline and breast-feeding. N Engl J Med. 1997 Abstract Full text (in our servers)
  53. Mammen OK, Perel JM, Rudolph G, Foglia JP, Wheeler SB. Sertraline and norsertraline levels in three breastfed infants. J Clin Psychiatry. 1997 Abstract
  54. Lesaca TG. Sertraline and galactorrhea. J Clin Psychopharmacol. 1996 Abstract
  55. Wisner KL, Perel JM, Findling RL. Antidepressant treatment during breast-feeding. Am J Psychiatry. 1996 Sep;153(9):1132-7. Review. Abstract
  56. Altshuler LL, Burt VK, McMullen M, Hendrick V. Breastfeeding and sertraline: a 24-hour analysis. J Clin Psychiatry. 1995 Abstract

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