This retrospective case series reviews a cohort of women with epilepsy on cenobamate during pregnancy, to better understand this medication’s safety in the antepartum period.

Cenobamate has become a widely used, efficacious add-on medication in drug-resistant epilepsy (DRE), with impressive rates of seizure frequency reduction. Its safety in pregnancy remains uncertain and understudied, with only some evidence in animal studies that the drug crosses the placenta and may be associated with teratogenic effects.

Seven patients who were prescribed cenobamate during pregnancy were identified by their epilepsy providers and contacted for consent. Information regarding their epilepsy history, pregnancy, and postpartum course was obtained from chart review and patient interviews.

All seven patients had DRE (6 focal, 1 generalized), having tried on average six anti-seizure medications in the past. They were all on cenobamate prior to pregnancy, and had improved seizure frequency with its addition, with three achieving seizure freedom. During pregnancy, cenobamate dosing ranged from 75 to 300mg daily, and all were on at least one other ASM. Six patients had breakthrough seizures while pregnant, prompting medication adjustment, and cenobamate’s dose was increased in three. Cenobamate levels were not monitored in these patients. Maternal complications included one case of postpartum pre-eclampsia and one emergent C-section for non-reassuring fetal heart rate. One mother went into premature labor at 34 weeks, and her baby required a NICU stay. Fetal complications included one infant with fetal growth restriction (<3^rd percentile) and two babies with low birth weight (<2500g). All of the babies had reassuring Apgar scores (≥8) at delivery. No congenital or developmental abnormalities were reported.

This case series suggests that women on cenobamate can have a healthy pregnancy and child, but further studies and clearer guidelines for dosing and monitoring are needed to establish a more comprehensive risk-benefit profile.