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You Asked: How Worrisome is the Boxed Warning for the New Postpartum Depression Medication?

You Asked: How Worrisome is the Boxed Warning for the New Postpartum Depression Medication?

Last year, the Food and Drug Administration approved the first oral medication for the treatment of postpartum depression. Zuranolone is now being marketed under the brand name ZURZUVAE by Sage Therapeutics in partnership with Biogen. 

Clinical trials have indicated that zuranolone is generally well-tolerated. The most common adverse events reported have included somnolence, dizziness, and sedation. While the intravenous medication brexanolone has been associated with some cases of sudden loss of consciousness, this adverse event was not observed with zuranolone. 

While zuranolone is a reasonable option for some women with postpartum depression, clinicians and patients are understandably cautious about trying new medications and have raised questions about the boxed warning included in its package insert.

 ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects.

Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE.

We suspect that what we would tell patients starting zuranolone is similar to what we would tell patients who are initiating treatment with a benzodiazepine. This class of medications can cause sedation and incoordination, and we typically counsel patients to be careful when starting a benzodiazepine; however, for this class of medications, the FDA did not include a boxed warning recommending driving restrictions when taking benzodiazepines. 

At this point, we do not yet have a lot of clinical experience with this medication and cannot comment on the degree of sedation or driving impairment that is typical of zuranolone. Practically speaking, a total ban on driving would be a concern to most new parents. However, the warning more specifically states that one should not drive 12 hours after taking the medication. In most cases, this would mean taking the medication at bedtime and waiting until the next day to drive, which is probably an acceptable restriction.

Nonetheless, the boxed warning seems more cautious than what the clinical trials would seem to warrant. 

If you have had experience with zuranolone as a clinician or a patient, please feel free to send in a comment. We are eager to hear about others’ experiences.

Ruta Nonacs, MD PhD

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