Are buspirone (Buspar) and escitalopram (Lexapro) safe to use during pregnancy in a typical healthy adult woman?

Safety of Buspirone (Buspar) and Escitalopram (Lexapro) in Pregnancy

Escitalopram (Lexapro) should be continued during pregnancy at the lowest effective dose if clinically indicated, as the benefits of treating depression often outweigh potential risks, while buspirone (Buspar) should be avoided due to insufficient human safety data. 1, 2, 3

Escitalopram (Lexapro): Acceptable with Precautions

Evidence Supporting Use

• The American Academy of Pediatrics recommends continuing escitalopram during pregnancy at the lowest effective dose when clinically indicated, recognizing that untreated depression carries substantial risks including premature birth, decreased breastfeeding initiation, and harm to the mother-infant relationship. 1, 2
• Large population-based studies have not demonstrated an increased risk of cardiac malformations with first-trimester escitalopram use. 4
• The rate of major malformations with escitalopram exposure is substantially within the range reported in unexposed women. 5, 6

Known Risks and Management

Third-trimester exposure risks:

• Neonatal adaptation syndrome occurs in approximately one-third of exposed newborns, presenting with crying, irritability, jitteriness, tremors, poor feeding, and sleep disturbance. 1, 7
• Symptoms typically appear within hours to days after birth and resolve within 1-2 weeks without intervention in most cases. 1, 7
• Arrange for early follow-up after hospital discharge and monitor infants for at least 48 hours after birth. 1, 7

Dose-dependent concerns:

• QT prolongation is a dose-dependent risk; the FDA recommends not exceeding 20 mg daily in adults over 60 years. 1
• Use the lowest effective dose throughout pregnancy. 1, 2

Possible association with persistent pulmonary hypertension of the newborn (PPHN):

• The number needed to harm is approximately 286-351, indicating a small absolute risk. 2, 7

Clinical Algorithm for Escitalopram

1. If already taking escitalopram when pregnancy is discovered: Continue at the lowest effective dose rather than discontinuing, as withdrawal increases relapse risk significantly. 1, 2
2. If initiating treatment during pregnancy: Consider sertraline as first-line due to more extensive safety data, but escitalopram remains acceptable if sertraline is ineffective or not tolerated. 2, 4
3. Monitor throughout pregnancy: Assess fetal growth, maternal blood pressure, and appropriate weight gain. 2
4. At delivery: Ensure neonatal monitoring for at least 48 hours for signs of adaptation syndrome. 1, 7

Buspirone (Buspar): Avoid Due to Insufficient Data

Evidence Against Use

• The FDA drug label classifies buspirone as Pregnancy Category B, stating "adequate and well-controlled studies during pregnancy have not been performed" and recommends use "only if clearly needed." 3
• Animal reproduction studies at 30 times the maximum human dose showed no fertility impairment or fetal damage in rats and rabbits, but human data are lacking. 3
• No published guidelines or high-quality studies address buspirone safety in human pregnancy. 8

Practical Recommendation

Switch to a better-studied alternative before conception or early in pregnancy. For anxiety disorders, sertraline is the preferred first-line agent due to extensive safety data and minimal breast milk excretion. 2, 4

Critical Comparison: Why Escitalopram is Acceptable but Buspirone is Not

The key distinction lies in the volume and quality of human safety data:

• Escitalopram has multiple large population-based studies, systematic reviews, and meta-analyses documenting outcomes in thousands of exposed pregnancies. 4, 9, 5, 6
• Buspirone has only animal data and theoretical safety, with no adequate human pregnancy studies to guide clinical decision-making. 3

Common Pitfalls to Avoid

1. Do not discontinue effective psychiatric medication abruptly upon pregnancy discovery. Women who discontinue antidepressants during pregnancy show significantly increased relapse risk of major depression. 2, 7

2. Do not avoid all psychiatric treatment due to fear of medication risks. Untreated maternal depression carries substantial documented risks to both mother and infant that often exceed medication risks. 1, 2

3. Do not use paroxetine or fluoxetine as alternatives. These SSRIs have the strongest associations with major malformations and should be avoided in favor of sertraline or escitalopram. 4, 9

4. Do not fail to arrange neonatal monitoring. Even with acceptable medications like escitalopram, newborns require observation for adaptation syndrome symptoms. 1, 7

Breastfeeding Considerations

Escitalopram: Can be continued during breastfeeding with infant monitoring for excess sedation, restlessness, agitation, poor feeding, and poor weight gain. 10, 6

Buspirone: The FDA label states that buspirone and its metabolites are excreted in rat milk, and recommends avoiding administration to nursing women if clinically possible due to unknown human excretion. 3