Is sertraline (Zoloft) safe to use during pregnancy?

Sertraline Use During Pregnancy

Sertraline is generally safe to use during pregnancy, with its benefits typically outweighing potential risks for women who need treatment for depression or anxiety. 1

Safety Profile of Sertraline in Pregnancy

Sertraline has one of the most favorable safety profiles among antidepressants for use during pregnancy:

• First trimester exposure: Recent evidence suggests no link between first-trimester SSRI use and cardiac malformations 2, 1
• Third trimester considerations: Late pregnancy exposure to sertraline may be associated with:
  • Persistent pulmonary hypertension of the newborn (PPHN), though with a high number needed to harm (286-351) 2, 1
  • Neonatal adaptation syndrome with symptoms including respiratory distress, irritability, feeding difficulties, and temperature instability 3

Benefits vs. Risks Assessment

Maternal Benefits

• Treating depression during pregnancy is important as untreated depression is associated with:
  • Premature birth
  • Decreased breastfeeding initiation 2, 1
  • Increased risk of relapse during pregnancy when medication is discontinued 3

Fetal/Neonatal Considerations

• FDA label notes potential complications in neonates exposed to sertraline late in the third trimester, including respiratory support needs and feeding difficulties 3
• Animal studies showed delayed ossification at high doses and increased stillbirths/mortality at doses equivalent to the maximum recommended human dose 3

Dosing Considerations

• Use the lowest effective dose during pregnancy 2, 1
• Sertraline clearance is reduced by 42% in CYP2C19 poor metabolizers 4
• Pharmacokinetic changes during pregnancy may require dose adjustments:
  • For extensive and ultrarapid metabolizers: 100-150 mg daily may be needed throughout gestation
  • For poor metabolizers: 50 mg daily during first trimester, potentially increasing to 100 mg in second and third trimesters 5

Breastfeeding Considerations

Sertraline is one of the preferred antidepressants during breastfeeding:

• Sertraline is minimally excreted in breast milk (<10% of maternal daily dose) 2, 1
• Median infant exposure is approximately 0.95% of the weight-adjusted maternal dose 4
• Infant plasma concentrations are typically 25-33% of maternal levels 6, 4
• Monitoring recommendations for breastfed infants:
  • Watch for irritability, poor feeding, or sleep disturbances 7
  • Particular caution with premature or low birth weight infants 7

Practical Recommendations

1. For women already on sertraline who become pregnant:

   • Generally continue treatment rather than discontinuing, as benefits often outweigh risks 3
   • Consider therapeutic drug monitoring to identify poor metabolizers at risk for adverse effects 6

2. For women starting treatment during pregnancy:

   • Begin with low doses and increase slowly based on response 7
   • Target the lowest effective dose 7

3. For the third trimester:

   • Be aware of potential neonatal adaptation syndrome
   • Ensure neonatal monitoring for the first week of life with early follow-up after discharge 2

4. For breastfeeding:

   • Sertraline is considered one of the safest antidepressants during lactation 7
   • To minimize exposure, consider timing breastfeeding to avoid peak milk concentration when feasible 7

Sertraline represents a reasonable choice for treating depression during pregnancy when the benefits of treatment outweigh the potential risks, with careful monitoring of both mother and infant.