The first oral pill designed specifically for postpartum depression was approved by the US Food and Drug Administration (FDA) in August 2023. The drug, Zurzuvae (zuranolone), is manufactured by the same company that previously made brexanolone, a similar product that was given through an intravenous (IV) infusion.
Postpartum depression is a serious condition, and there are a limited number of treatment options. The new drug, Zurzuvae, received both Priority Review and a Fast Track designation from the FDA to expedite its approval, as it was expected to significantly improve safety and serve an unmet need. Still, the new drug comes with risks and side effects, and because it was tested on a limited number of people, we’re likely to learn a lot more about it in the next several years as it is used in real-world situations. Here’s what we know about Zurzuvae now.
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How Are Depression and Postpartum Depression Different?
One in eight women experience postpartum depression, according to data from the Centers for Disease Control and Prevention (CDC). Symptoms of postpartum depression are very similar to those of depression at any other time of life and include things like feeling sad, anxious or numb, losing energy, losing interest in activities you used to enjoy, changes in appetite, hopelessness, and aches and pains. People with postpartum depression may also feel guilt about not taking care of or bonding with their baby, fear that they will hurt the baby, anger, and pull away from loved ones.
How Long Does Postpartum Depression Last?
Postpartum depression can last for months if it’s not addressed, and many people who experience postpartum depression also have experienced other mental health conditions.
Does the New Postpartum Depression Drug Zurzuvae Work?
The mechanism by which Zurzuvae treats depression isn’t fully understood. It’s known to mimic a chemical in the brain that usually attaches to gamma-aminobutyric acid type a (GABAa) receptors, which are found throughout our brain and body. They have many functions, but one of the main effects of stimulating them is the feeling of relaxation or tiredness. Both alcohol and anti-anxiety medications called benzodiazepines bind to parts of these receptors.
Zurzuvae’s approval was based on two clinical trials. They were both relatively small, including 151 and 170 patients, respectively. The participants of both studies took one pill a day for two weeks, and their postpartum depression symptoms were evaluated several times, starting at three days after the first dose. Researchers noted an improvement in their symptoms at three days, which is one of the main perks of the drug. Many antidepressants can take weeks to kick in.
The test used to assess depression was a 17-point scale. Over the course of the trials, participants in both the study drug and placebo groups—those who took the drug and those who took a placebo—lessened their symptoms of depression. However, those who were given Zurzuvae experienced greater improvements than patients on the placebo drug, and the difference was statistically significant. Those on the drug improved by four points more than the placebo group out of the 17.
How Long Did the Studies Last?
Zurzuvae is only designed to be taken for two weeks. However, the trials continued following the patients after the medication was stopped, monitoring their status intermittently for a total of 45 days.
One large multicenter trial showed that the drug helped patients with more severe major depressive disorder, who saw benefits for the first 15 days. But by six months, there was no difference between the placebo group and those that had been given Zurzuvae.
What Do We Know About Zurzuvae’s Side Effects?
The clinical trials for Zurzuvae weren’t very long; they only lasted about four weeks. However, because the drug works on the same receptors as benzodiazepines, drugs that are known to be highly addictive, people who are prescribed Zurzuvae could be at risk of developing a substance use disorder or experiencing withdrawal symptoms when they stop taking it.
The most common side effects reported in the clinical trials included the following:
- Sleepiness
- Dizziness
- Diarrhea
- Fatigue
- Runny or stuffy nose
- Urinary tract infections (UTIs)
Taking Zurzuvae while pregnant could harm your baby, according to findings from animal studies.
Because the drug causes drowsiness, the label contains a warning that you should not drive within 12 hours of having taken it. Experts recommend taking it shortly before you go to bed.
What Patients Are Reporting
It’s important to keep in mind that nearly one-third of all drugs receive new warnings within 10 years of approval. The clinical trials for Zurzuvae were relatively small, and it’s likely we’ll learn a lot more about the drug’s side effects as more people take it over the next several years. This drug is so new that there are no reports of side effects so far on AskAPatient.com. However, some patients have taken to Reddit to share their experiences. It’s important to note that MedShadow can not verify the identities of these patients or the validity of the experiences they describe.
There, one woman said she felt like herself again after four days of taking the drug, but then she said it felt as if the drug completely stopped working on day five.
Another woman said the medication helped her feel a little less overwhelmed and able to focus. It did make her dizzy. She also got the flu (along with the rest of her family) and then developed a UTI, which progressed into a kidney infection.
A third woman reported that she felt that the drug worked but also caused her slightly blurry vision, muscle twitches, and some memory problems.
Then, she updated again about a week-and-a-half after having stopped the drug, saying that during the second week of using the medication, her symptoms had worsened.
“My mood really tanked that Saturday (which was a little over halfway through her prescribed course), and I became very irritable and felt as bad as I ever did on my bad days. Then, on Sunday, things got so much worse. That was the first time I ever really felt depressed,” she wrote. The woman also added that she’d started to feel brain fog as if she was drunk during the day. Once she stopped taking the drugs, the side effects abated, but she still felt depressed.
Can You Breastfeed While Taking Zurzuvae?
According to the drug prescribing label, there’s some evidence that Zurzuvae can cross into breast milk, though it shows the amounts are low. Because the manufacturer asked the women in the clinical trials not to breastfeed while taking the drug, there is no data yet on how this might affect an infant. It’s important to discuss whether to continue breastfeeding or to take a break while taking Zurzuvae.
Postpartum depression is an undoubtedly dangerous and difficult condition with few treatment options. However, it’s important to keep in mind that this treatment was only tested on a couple hundred women, and we have a lot left to learn about how it works and its possible side effects.
Before you start taking any medication, be sure to ask your healthcare provider about the most recently updated findings related to patients like you, their own experience prescribing it to other patients, and what other treatment options you may have.
