What To Know About First FDA-Approved Oral Medication For Postpartum Depression Zurzuvae

Pregnancy and childbirth can be both extremely rewarding and extremely stressful. After giving birth, a person can experience a vast range of emotions, including joy, sadness and a general feeling of overwhelm. Typically, the more difficult emotions lessen two weeks after childbirth, but people who continue to experience a powerful sense of sadness may be dealing with postpartum depression (PPD).

“While hormonal fluctuations and corresponding alterations in mood are common in the first couple of weeks after delivery, postpartum depression is differentiated by more profound and persistent symptomology,” notes Sabrina Romanoff, Psy.D., a Harvard-trained clinical psychologist, professor and Forbes Health Advisory Board member. “When left untreated, symptoms tend to exacerbate and turn into a more chronic condition,” she adds.

It’s not uncommon for PPD to go undiagnosed due to a lack of awareness, which can lead to birthing parents not being screened properly at routine health visits or their symptoms being chalked up to a case of the more common (but also uniquely challenging) “baby blues,” says Olivia Verhulst, a New York-based licensed psychotherapist and Forbes Health Advisory Board member who specializes in maternal mental health.

As noted by Dr. Romanoff, the “baby blues” typically lasts for two to three weeks following childbirth and is caused by a number of hormonal shifts. Meanwhile, postpartum depression can last much longer and even occur during pregnancy, notes Verhulst.

Affecting about one in seven birthing people, PPD can be marked by symptoms ranging from sleep issues and anxiety to feelings of overwhelm and a preoccupation with a baby’s health^[1]Postpartum Depression. Statpearls [Internet]. Accessed 8/7/2023. . PPD is thought to be caused by a sharp decrease in hormone levels after childbirth, although further research is needed to better understand the condition.

Treatment for PPD typically involves therapy and the use of medication, such as selective serotonin reuptake inhibitors (SSRIs).

Zurzuvae (zuranolone) is an oral medication that’s similar in nature to brexanolone, an intravenous medication approved by the FDA in 2019 for the treatment of PPD. Both brexanolone and zuranolone are known as positive allosteric modulators of GABA-A receptors, which reside in the benzodiazepine/barbiturate class of medications.

“Zuranolone works by modulating a neurotransmitter called GABA-A,” explains Sarah Oreck, M.D., a Columbia University-trained psychiatrist who specializes in women’s mental wellness. GABA is believed to be connected to the development of depression, Dr. Oreck continues, with reduced levels seen in the cerebrospinal fluid and brain tissue of individuals with depression.

“Zuranolone is a man-made version of allopregnanolone, a hormone that occurs naturally in the brain that reduces the stress response and reduces symptoms of depression,” adds Dr. Romanoff. “Allopregnanolone levels tend to drop during the period after birth. The drug zuranolone works to correct for that drop and increases allopregnanolone levels back to a normal range.”

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The FDA approved Zurxuvae after reviewing the results of two randomized, double-blind, placebo-controlled, multicenter studies.

In the first study, individuals diagnosed with PPD consumed either 50 milligrams of Zurxuvae or a placebo once daily for 14 days^[2]Clayton AH, Lasser R, Parikh SV, et al. Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo‐Controlled Phase 3 Trial. The American Journal of Psychiatry. 2023;appiajp20220459. . In the second study, individuals with PPD consumed a zuranolone product equal to 40 milligrams of Zurzuvae or a placebo once daily for 14 days^[3]FDA Approves First Oral Treatment for Postpartum Depression. U.S Food and Drug Administration. Accessed 8/2/2023. . Researchers followed individuals in both studies for at least four weeks after the studies concluded, observing that those who received Zurxuvae showed “significantly more improvement in their symptoms” than participants who received a placebo.

“This drug is extremely promising, as it has rapid action—only 14 days, which is significant compared to most psychiatric medications (which can take up to a month to have a full effect),” notes Dr. Romanoff.

As excited as she is about this development, Dr. Oreck says there are still a few questions regarding accessibility and cost of this new medication. “We have yet to answer questions about affordability and how accessible it will be to those who need it most. Zuranolone’s predecessor (braxanolone) is an infusion that requires 60 hours to administer and an out-of-pocket cost of up to $34,000. I’m excited that a medication that may be taken at home will be much more far reaching,” she says.

The current recommended dose of Zurzuvae for most patients prescribed the medication is 50 milligrams once daily for 14 days (similar to its administration in clinical trials). Individuals are advised to take Zurzuvae with a meal that includes fats to increase absorption. Dr. Romanoff notes that side effects may include sedation, fatigue, dizziness and headaches. The FDA also notes that if suicidal thoughts and behaviors occur while taking Zurzuvae, it should be discontinued.

Additionally, Dr. Oreck says recent studies on zuranolone exclude pregnant or nursing individuals, so more research is needed to further understand if it’s safe for these groups and how the medication may be transmitted via breast milk.

If you think you or your spouse or partner may be living with PPD, talk to your primary care physician or a mental health care professional like a therapist or psychiatrist. Medication and therapy can be highly effective in alleviating symptoms of PPD, allowing one to better weather and enjoy all the moments of new parenthood.