Sertraline (Zoloft®)

Selected References:

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• Anderson KN, et al. 2020. Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects. JAMA Psychiatry. 77(12):1246-1255. 
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• Aynaoglu, Y., et al. 2021. Effect of diazepam, sertraline, and melatonin on the stress-induced reproductive in female rats. J Matern Fetal Neonatal Med. 34(24): 4103-4109. 
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• Den Besten-Bertholee D, et al. 2024. Sertraline, citalopram and paroxetine in lactation: passage into breastmilk and infant exposure. Front Pharmacol. 15:1414677. 
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• Grigoriadis et al. 2014. Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis. BMJ 348:f6932 
• Heinonen E, et al. 2021. Sertraline concentrations in pregnant women are steady and the drug transfer to their infants is low. Eur J Clin Pharmacol. 77(9):1323-1331. 
• Hendrick V, et al. 2001. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 179:163-166. 
• Hogue AN, et al. 2017. Effects of in-utero exposure to selective serotonin reuptake inhibitors and venlafaxine on term and preterm infants. J Neonatal Perinatal Med. 10(4):371-380. 
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• Kallen BAJ, et al. 2007. Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations. Birth Defects Res A Clin Mol Teratol 79(4):301-308. 
• Kieler H, et al. 2011. Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: a population based cohort study from five Nordic countries. BMJ 344:d8012. 
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• Kolding L et al. 2019. Sertraline use during pregnancy and effect on fetal cardiac function. J Maternal Fetal Neonatal Med. 12:1-8. 
• Kristensen JH, et al. 1998. Distribution and excretion of sertraline and N-desmethylsertraline in human milk. Br J Clin Pharmacol 45:453-457. 
• Levinson-Castiel R, et al. 2006. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 160:173-176.  
• Leutritz AL, et al. 2023. Psychotropic medication in pregnancy and lactation and early development of exposed children. Br J Clin Pharmacol. 89(2):737-750. 
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• Mammen OK, et al. 1997. Sertraline and norsertraline levels in three breastfed infants. J Clin Psychiatry 58:100-103. 
• Marks C, eral. 2021. Comparing newborn outcomes after prenatal exposure to individual antidepressants: A retrospective cohort study. Pharmacotherapy. 41(11):907-914. 
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• Nulman I, et al. 1997. Neurodevelopment of children exposed in utero to antidepressant drugs. N Engl J Med 336 (4):258-262. 
• Oberlander TF, et al, 2008. Major congenital malformations following prenatal exposure to serotonin reuptake inhibitors and benzodiazepines using population based health data. Birth Defects Res B Dev Reprod Toxicol. 83(1):68 76. 
• Pedersen LH, et al. 2009. Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ 339:b3569. 
• Pinheiro E, et al. 2015. Sertraline and breastfeeding: review and meta-analysis. Archives of Women’s Mental Health. 18(2):139-46. 
• Rommel A.-S.,et al. 2020. Long-term effects of intrauterine exposure to antidepressants on physical, neurodevelopmental, and psychiatric outcomes: A systematic review. J Clin Psychiatry 81(3): 19r12965.  
• Sanz E, et al. 2005. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet 365:482-487. 
• Semet M, et al. 2017. The impact of drugs on male fertility: a review. Andrology 5(4): 640-663. 
• Sjaarda LA, et al. 2020. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: A prospective cohort study of fecundability and pregnancy loss. Fertility and Sterility, 114(6):1278–1287.  
• Stika C, et al. 2022. Changes in sertraline plasma concentrations across pregnancy and postpartum.  Clin Pharmacol Ther. 112(6):1280-1290. 
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• U.S. Food and Drug Administration. 2011 (current as of 2/13/2018). Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-selective-serotonin-reuptake-inhibitor-ssri-antidepressant-use-during#data. [Accessed 12/19]. 
• U.S. Food and Drug Administration. 2023. Zoloft® Drug Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf. [Accessed 8/2025]. 
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• Womersely K, et al. 2017. What are the risks associated with different Selective Serotonin Re-uptake Inhibitors (SSRIs) to treat depression and anxiety in pregnancy? An evaluation of current evidence. Psychiatr Danub. 29(Suppl. 3):629-644. 
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