Ms. P is a 32-year-old married woman who presented for consultation regarding the use of medication during pregnancy.  She had been taking fluoxetine (Prozac) 20 mg for many years for the treatment of recurrent major depression and generalized anxiety.  In addition, she was prescribed gabapentin (Neurontin) for sleep.

During the consultation, we reviewed the risks and benefits of using fluoxetine during pregnancy.  Prior to this visit, Ms. P had tried several times to gradually come off the fluoxetine but had experienced recurrent anxiety.  Given the well-characterized reproductive safety profile of fluoxetine, Ms. P decided that she would prefer to continue on this medication during the course of her pregnancy.

The discussion regarding the use of gabapentin was more complicated.  Without it, Ms. P reported difficulty falling asleep and worse anxiety.  Data regarding the reproductive safety of gabapentin is limited.  A recent study included 59 infants exposed to gabapentin; one (1.7%) was noted to have a major malformation.  This study lacks sufficient data to meaningfully assess the reproductive safety of gabapentin.  It is estimated that at least 400 to 600 exposures would be required to detect a 2-fold increase in more common malformations.  In general, we try to avoid the use of gabapentin during pregnancy, as there are other alternatives that are better characterized for use during pregnancy.

We discussed several other options for managing her sleep and residual anxiety:

1.       Cognitive-behavioral therapy may be useful for managing residual anxiety and sleep disturbance and may help to minimize exposure to medication.

2.       She might benefit from an increased dose of fluoxetine to manage her residual anxiety and depression and allow her to discontinue gabapentin.

3.       She might consider adding a tricyclic antidepressant.  Cumulative data suggest no increase in risk of malformation with this class of medications.

4.       She might consider treatment with a benzodiazepine.  Although initial reports suggested that there may be an increased risk of cleft lip and cleft palate, more recent reports have shown no association between exposure to benzodiazepines and risk for cleft lip or palate. Pooling the data suggests that this risk– if it exists — is estimated to be 0.7%.

5.       Another option might be a sedative-hypnotic agent, such as zolpidem, although this class of medication is not as well-characterized as the options listed above.

Ruta Nonacs, MD PhD


Mølgaard-Nielsen D, Hviid ANewer-generation antiepileptic drugs and the risk of major birth defects.  JAMA 2011;305(19):1996-2002.