Buspirone Safety in Pregnancy
Buspirone can be used during pregnancy when clinically necessary, as current evidence shows no increased risk of major congenital malformations, though data remain limited and the FDA label recommends use only if clearly needed.
FDA Classification and Official Guidance
Buspirone is classified as Pregnancy Category B by the FDA, meaning animal reproduction studies showed no fertility impairment or fetal damage at approximately 30 times the maximum recommended human dose, but adequate well-controlled studies in pregnant women have not been performed. 1
The FDA label explicitly states that buspirone "should be used during pregnancy only if clearly needed" given the lack of human data despite reassuring animal studies. 1
Buspirone should be discontinued at least 48 hours before urine catecholamine testing to avoid false-positive results for pheochromocytoma. 1
Human Pregnancy Data
The most rigorous prospective human data comes from the Massachusetts General Hospital National Pregnancy Registry, which followed 68 evaluable women (72 infants including twins) exposed to buspirone during the first trimester and found zero major malformations. 2
This represents the only prospectively ascertained cohort of first-trimester buspirone exposure with systematic outcome assessment through maternal interview and medical record review at 12 weeks postpartum. 2
While the sample size is modest, the complete absence of malformations in a rigorously monitored cohort provides meaningful reassurance. 2
Clinical Decision Algorithm
When a pregnant woman requires anxiolytic treatment:
First-line approach: Consider SSRIs (particularly sertraline or citalopram) over buspirone, as they have more extensive pregnancy safety data for anxiety disorders. 3
Buspirone as alternative: If SSRIs are contraindicated, ineffective, or not tolerated, buspirone represents a reasonable option given the absence of observed malformations in prospective data. 2
If already taking buspirone: Women who become pregnant while on buspirone can continue the medication after informed discussion of the limited but reassuring data. 1, 2
Avoid polypharmacy: Do not combine buspirone with benzodiazepines during pregnancy unless absolutely necessary, as benzodiazepines carry their own fetal risks. 4
Important Caveats and Monitoring
Hepatic/renal impairment: Buspirone is contraindicated in severe hepatic or renal impairment due to increased plasma levels and prolonged half-life. 1
Drug interactions: Buspirone is metabolized by CYP3A4; avoid concurrent use with potent inhibitors (ketoconazole, ritonavir) or inducers (phenytoin, carbamazepine) without dose adjustment. 1
Labor considerations: The effect of buspirone on labor and delivery is unknown, though no adverse effects were noted in rat reproduction studies. 1
Lactation Considerations
Buspirone and its metabolites are excreted in rat milk, and the extent of human milk excretion is unknown. 1
The FDA label recommends avoiding buspirone administration to nursing women "if clinically possible." 1
If breastfeeding is necessary while taking buspirone, monitor the infant closely for sedation, poor feeding, or developmental concerns. 1
Comparative Context
Buspirone versus other anxiolytics in pregnancy:
Buspirone has more favorable data than benzodiazepines, which should be avoided chronically during pregnancy and are contraindicated during labor and the first postpartum week. 4
SSRIs (sertraline, citalopram) have more extensive reproductive safety data and should generally be preferred for anxiety disorders in pregnancy. 3
Non-pharmacologic interventions (cognitive-behavioral therapy) should be attempted first-line when feasible before any anxiolytic medication. 5