Zuranolone: FDA-Approved Oral Medication for Postpartum Depression Treatment

Zuranolone: What You Need to Know About the FDA-Approved Postpartum Depression Drug

On August 4, 2023, the U.S. Food and Drug Administration (FDA) approved the use of oral zuranolone to treat postpartum depression under the brand name Zurzuvae.  This is the first oral medication indicated for the treatment of this disorder as previously only brexanolone, a 60-hour intravenous in-hospital infusion, was the only FDA-approved option available, and often not readily so.  In light of this new development in postpartum depression, read on for some things you need to know about zuranolone.

What is zuranolone and how does it work?

Zuranolone is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor-positive modulator.  It is a synthetic form of allopregnanolone, a neurosteroid naturally synthesized in the body.  Zuranolone works by enhancing the effectiveness of the GABA A receptors, which are responsible for mood regulation.  It is believed that, in women suffering from postpartum depression, there is insufficient allopregnanolone to stimulate GABA A receptor activity, thus leading to symptoms such as irritability, anxiety, and depression among others.

What are the side effects of zuranolone? What precautions are needed when taking it?

In a Phase III clinical trial, new mothers diagnosed with postpartum depression took zuranolone once a day for two weeks and were followed for 45 days to observe results.  The side effects reported during the trial were dizziness, sleepiness, diarrhea, cold-like symptoms, fatigue, and UTI.  Patients taking zuranolone are advised not to drive for at least 12 hours after taking each dose.  Serious adverse reactions to zuranolone include CNS depression (drowsiness, confusion, etc.) and an increase in suicidal thoughts and behaviors.  Clients and their support persons should be counseled about watching for these potential adverse effects and seeking help immediately should they develop.

Also, zuranolone does pass into breast milk and it is as yet unknown what harm if any the drug can do to a baby.  Because of this, trial participants did not breastfeed while taking zuranolone.  Similarly, there is potential for fetal harm if pregnancy occurs in patients taking zuranolone, so it is recommended that they utilize effective contraception during the two-week treatment period.

The results of the zuranolone clinical trial for postpartum depression showed a significant drop in the rating scale used to gauge depressive symptoms and demonstrated improvement within three days of treatment. It is unknown how long past the 45-day trial period the drug maintains its effects.

Why is this development important?

The leading causes of overall and preventable maternal mortality are suicide and overdose secondary to perinatal mental health conditions.  One in seven women is affected by perinatal depression (14%), so understanding the underlying causes, treatment options, and support resources is essential for addressing and reducing the harm from perinatal mood disorders.  And while zuranolone is not a “magic pill,” it could be the solution that some people suffering from severe postpartum depression need.  It is a tool, one of many we can use to help those for whom it is indicated.  For them, it could potentially be the difference between life and death.

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