What to Know About Zurzuvae, the Fast-Acting Postpartum Depression Drug

Fact checked by Nick Blackmer

Key Takeaways

• The FDA-approved treatment for severe postpartum depression—Zurzuvae—is expected to launch in the fourth quarter of 2023.

• Zurzuvae is the first-ever oral pill approved in the U.S. for treating postpartum depression. The only other approved treatment is Zulresso, a 60-hour IV drip.

• Zurzuvae showed promising results in its ability to lessen severe depression symptoms in as little as three days, but there's no data on its long-term effectiveness or safety yet.
  

The Food and Drug Administration (FDA) has approved the first-ever oral pill that treats postpartum depression, the most common complication that comes with childbirth.

The new drug, Zurzuvae (zuranolone), is a once-daily oral pill taken for just two weeks and works much faster than other antidepressants. This treatment is also less invasive than Zulresso, an extremely expensive 60-hour IV drip that was approved in 2019.

Health experts and advocacy groups welcomed the approval of the drug, given the lack of treatment options for postpartum depression, a life-threatening condition that can occur in the first year after childbirth and may even begin during pregnancy.

Postpartum depression, also called PPD, can interfere with new mothers’ ability to care for themselves and their babies, according to Suzy Lipinski, MD, a board-certified OB-GYN at Pediatrix Medical Group in Denver, Colorado.

“This is a severe, potentially life-threatening pregnancy complication that has a lot of stigma, which limits women seeking treatment,” Lipinski told Verywell.

U.S. data from 2018 suggest that about 13% of women who had given birth developed PPD, but as many as 60% of them didn’t get diagnosed by healthcare providers, and only half received treatment. While the focus is often on new mothers, research has found that the condition can affect almost one in 10 fathers.

Related: What Is Postpartum Psychosis?

How Effective Is Zurzuvae?

In two separate trials, Zurzuvae showed promising results in its ability to lessen severe PPD symptoms, with some participants experiencing improvement in as little as three days. Most traditional antidepressants take four to six weeks to show benefits.

Most antidepressants like SSRIs are used for a minimum of six months, but Zurzuvae is designed for short-term, intensive treatment of severe PPD, according to Andrea Braden, MD, FACOG, IBCLC, a board-certified OB-GYN, breastfeeding medicine specialist, and lactation consultant specializing in perinatal mood and anxiety disorders.

But the medication was only tested on people with severe PPD, for a period of 45 days, and only on people who weren’t breastfeeding.

Severe PPD often persists for months, so little is known about the long-term impact of the drug. “We don’t know anything about whether or not the drug has lasting effects on PPD or if it simply provides short-term relief of symptoms,” Braden told Verywell.

Participants in the clinical trials were also asked to stop breastfeeding while taking Zurzuvae. But having difficulty with breastfeeding has been associated with a higher risk of PPD, and a majority of new mothers in the U.S. do initiate breastfeeding.

Braden said testing Zurzuvae in a limited population means the positive results can’t be applied to many patients with PPD. More research is also needed on the transfer of the drug into human milk and its impact on breastfed infants, she added.

Still, the treatment goal for severe PPD is to get immediate relief of life-threatening symptoms such as suicidal or homicidal ideation, Braden said.

Traditional antidepressants may take weeks to improve symptoms and, until now, the only fast-acting treatment option has been to separate new mothers from their infants and admit them to hospitals for inpatient, intensive therapy.

“This sudden separation of mother and infant, while lifesaving, can severely impact mother-infant bonding,” Braden said. “Shorter-term effective treatment modalities such as Zurzuvae have the potential to treat severe PPD without worsening social stigma and minimizing the impact this debilitating illness may have on the family unit.”

Related: How Perinatal Depression Is Treated

How Is Zurzuvae Different From Regular Antidepressants?

Unlike regular antidepressants, Zurzuvae replaces a specific hormone that is reduced in the postpartum period, making this drug very specific to PPD, Lipinski explained.

Although Zurzuvae targets severe PPD, the FDA rejected Zurzuvae for the treatment of major depressive disorder (MDD) because the trials didn’t show the drug to have a significant effect on MDD.

Many other drugs have been shown to be effective in treating MDD, Braden said, whereas Zurzuvae is the only oral drug approved to treat PDD specifically.

“Scientific debate still exists about whether or not there is actually a difference between PPD and MDD that recurs during the perinatal period, since many cases of PPD occur in the setting of prior MDD,” Braden added.

What Are the Side Effects of Zurzuvae?

The most common side effects of Zurzuvae are headaches, dizziness, diarrhea, nausea, and excessive or sudden sedation (somnolence). Patients are therefore advised to take the drug at night, and they should avoid driving or operating heavy machinery during treatment.

As a result of this side effect profile, as well as speculation that the sedative effects of this class of drugs can be addictive, Zurzuvae is expected to be released as a controlled substance, according to Braden.

Since the trials were only 45 days long, the long-term side effects are unclear.

Lipinski added that lifestyle and counseling are integral to depression treatment and will not stop being valuable even with the new medication. Patients suffering from PPD should talk to their healthcare provider to discuss options to manage their symptoms. The release of Zurzuvae will be an additional option if the first-line treatments don’t work well enough.

“Postpartum depression is the most common complication of pregnancy and we as a society and in health care do not adequately recognize and treat it as the disease that it is,” Lipinski said. “It is my genuine hope that as this drug reaches the market, it will open the doors for more conversations, treatment, and acceptance of this illness.”

What This Means For You

Zurzuvae is a fast-acting oral pill for severe postpartum depression. It's expected to launch in the fourth quarter of 2023.