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

Last yr, 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 usually well-tolerated. Probably the most common hostile events reported have included somnolence, dizziness, and sedation. While the intravenous medication brexanolone has been related to some cases of sudden lack of consciousness, this hostile event was not observed with zuranolone. 

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

 ZURZUVAE causes driving impairment as a consequence of central nervous system (CNS) depressant effects.

Advise patients to not drive or engage in other potentially hazardous activities until at the very least 12 hours after ZURZUVAE administration at some point of the 14-day treatment course. Inform patients that they could not give you the chance to evaluate their very own driving competence, or the degree of driving impairment attributable to ZURZUVAE.

We suspect that what we’d tell patients starting zuranolone is analogous to what we’d tell patients who’re initiating treatment with a benzodiazepine. This class of medicines could cause sedation and incoordination, and we typically counsel patients to watch out when starting a benzodiazepine; nonetheless, for this class of medicines, the FDA didn’t include a boxed warning recommending driving restrictions when taking benzodiazepines. 

At this point, we don’t yet have loads of clinical experience with this medication and can’t comment on the degree of sedation or driving impairment that’s typical of zuranolone. Practically speaking, a complete ban on driving can be a priority to most latest parents. Nevertheless, the warning more specifically states that one shouldn’t drive 12 hours after taking the medication. Typically, this may mean taking the medication at bedtime and waiting until the subsequent day to drive, which might be a suitable restriction.

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

If you may have had experience with zuranolone as a clinician or a patient, please be at liberty to send in a comment. We’re wanting to hear about others’ experiences.

Ruta Nonacs, MD PhD

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