FDA Approves First-Ever Pill to Treat Postpartum Depression

The new drug brings hope to the hundreds of thousands of new parents struggling with the condition.

Fact checked by Sarah ScottMedically reviewed by Carly Snyder, MD

The Food and Drug Administration made history in August 2023 when it approved the first pill for treating postpartum depression (PPD). The drug, Zurzuvae (zuranolone), will be prescribed to be taken orally once daily for 14 days. According to the drugmakers, Sage Therapeutics and Biogen Inc., Zurzuvae provides "rapid improvements in depressive symptoms."

Zurzuvae could be available as soon as October after the U.S. Drug Enforcement Administration schedules it as a controlled substance, the companies reported in a news release.

The news brings hope that more help is on the way for a condition the Center for Disease Control and Prevention (CDC) says affects about 1 in 8 birthing people annually and is potentially life-threatening.

“It’s essential to work on improving access, support, and treatment options [that can] be tailored to fit the ideal treatment plan/approach for that person,” says Asima Ahmad, MD, the chief medical officer and co-founder of Carrot Fertility, a leading global fertility care platform.

Experts say this is good news, as the drug offers another option for those with PPD. Postpartum depression, while often debilitating, is treatable.

“With proper treatment, in most cases, postpartum depression symptoms will improve,” says Monte Swarup, MD, FACOG, an Arizona-based board-certified in OB/GYN and founder of the leading HPV information site HPV HUB.

Experts explain what Zurzuvae is, how it’s different from current treatments for postpartum depression, and why it’s not a replacement for meaningful changes to support new parents.

How Zurzuvae is Different From Other Medications for Postpartum Depression

Currently, providers will typically prescribe a class of medications known as selective serotonin reuptake inhibitors (SSRIs) to aid in treating postpartum depression.

“Antidepressant medications like selective serotonin reuptake inhibitors help balance the levels of serotonin in the brain, which helps improve symptoms of depression,” says Meleen Chuang MD, the Network Medical Director of Women’s Health at NYU Langone Family Health Center.

These drugs are not specific to postpartum depression and can take 30 days or more to show effects. Zurzuvae, which is specifically for postpartum depression, is distinct in both regards. Patients in the clinical trial saw improvements in as little as three days.

But Zurzuvae isn’t the first drug to be approved for PPD. The FDA approved Zulresso (brexanalone) in 2019, but it's an IV drug that needs to be administered over 60 hours at a medical facility to monitor for side effects. Zurzuvae can be taken orally and at home.

“The lower incidence of side effects, the short-term regimen, and faster onset of relief of symptoms could potentially improve the acceptance of treatment and compliance for those suffering from PPD,” Dr. Ahmad says.

Research done among people receiving inpatient treatment for postpartum depression suggests the disorder can hurt parents bonding with the infant. Dr. Swarup says the fast-acting effects may also help with that.

Side Effects and Concerns About Zurzuvae

Though Zurzuvae’s development is a significant development, Dr. Chuang notes the drug is new and does come with some concerns.

“These clinical trials only tested mothers for effects 45 days out of starting,” Dr. Chuang says. “Women who were breastfeeding or had mild to moderate depression were not involved in these trials.”

Dr. Chuang notes that most SSRIs currently prescribed for postpartum depression are considered safe for lactating parents.

“More clinical trials, tests, phase three trials using a much larger group of women with postpartum depression would be needed to determine whether the treatment would be safe and effective for a wide variety of postpartum women,” she says.

As with many medications, there are also side effects. The company warns of the potential for diarrhea, nausea, headaches, dizziness, and somnolence (excessive or sudden sedation). Because of these possible side effects, drugmakers caution against driving or operating heavy machinery while under the treatment.

The FDA also warns that using Zurzuvae may also cause suicidal ideation.

Other Treatments for Postpartum Depression

Dr. Swarup notes that medications are not the only tool for treating postpartum depression. The following may be used instead of in addition to pharmaceutical interventions:

• Talk therapy

• Support groups

• Self-care

Dr. Ahmad says it’s important for patients to explore the best options for them as part of shared decision-making with a provider.

“Everyone’s experience with PPD is different, and what works for one person may not work for another,” Dr. Ahmad says. “People respond to treatments differently, have different resources available to them, and consider different forms of treatment acceptable based on their cultures and beliefs, so it is important to have multiple treatment modalities and approaches in place to provide personalized plans for individuals that will result in the relief of their symptoms.”

Finally, while the drug should provide meaningful assistance to individuals struggling with postpartum depression, Dr. Ahmad says it’s not a replacement for significant systematic changes to better support postpartum parents. For instance, the United States is the only developed country without federal paid leave. A 2023 review of 38 studies indicated that mental health generally improved in women with longer leave.

“A new drug will not solve the bigger problem that is at hand,” Dr. Ahmad says. “In many cases, depression could be secondary to not having proper resources or support in place. We need to continue to advocate for parents to receive more support during pregnancy, postpartum, and after.”

Related: I Hid My Postpartum Depression for Too Long—Here's What I Want You To Know

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