FDA Approves Zurzuvae, First Pill For Postpartum Depression, What You Need To Know

Here’s some potentially uplifting news for those suffering from postpartum depression. On August 4, the U.S. Food and Drug Administration (FDA) announced that they have approved Zurzuvae, as the first ever oral medication for the treatment of postpartum depression.

Postpartum is pronounced like “post part, umm” with “post” meaning “after” and “partum” meaning “childbirth” in Latin. But postpartum depression shouldn’t be an “umm what” condition. It’s a major depressive episode that actually rather common, affecting an estimated one in seven women either in their later stages of pregnancy or after they have given birth. Yet, sadly postpartum depression often goes undiagnosed and untreated.

Zurzuvae is the two-Z brand name for zuranolone that will be the more easy alternative to Zulresso, which is the brand name for brexanolone. Sage Therapeutics, Inc. has been marketing Zulresso whereas Biogen Inc. and Sage Therapeutics, Inc. have developed and will market Zurzuvae. Zulresso ain’t exactly the most convenient of medications to get as Zulresso is typically administered as an intravenous infusion over a 60-hour period. Yes, 60 hours, which is like watching Zack Snyder’s Justice League movie 15 times. That’s not easy to do and not the type of thing that you can get at a local coffee shop. Instead, a Zulresso infusion usually requires admission to some type of healthcare facility like a hospital. Oh, and getting Zulresso could end up costing a pretty penny, potentially even as high as $34,000, according to a piece in the University of Michigan’s Michigan Medicine. That’s around the cost of a Tesla, a year of college tuition, or around 2300 apple trees sapplings, not that all of these things are necessarily interchangeable.

Having Zurzuvae, a new and presumably less expensive alternative, available can be welcome news to many mothers who feel like they have no alternative. A reason why you may suffer postpartum depression in silence is that such feelings could bring feelings of shame and guilt. You may be worried that revealing symptoms of depression may somehow reflect badly on your parenting. It could go against the unrealistic narrative that “You just had a baby and are supposed to be happy with lollipops and bunnies wearing sweater vests appearing everywhere so why not just taste the rainbow.” Reality, of course, can be very different. The FDA announcement quoted Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research as saying, “Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.” Clearly, PPD is not a fun thing to have.

It’s not completely clear, though, what may cause PPD. It may result from changes in the levels of hormones such as estradiol and progesterone, inflammation of various nerve cells, and changes in neurotransmitter levels. Zurzuvae is a steroid that acts on GABA_A receptors in your brain. GABA_A receptors are sort of like the little Meryl Streeps of your brain. They play may different roles including helping in the regulation of your mood and behavior.

The FDA granted approval to Zurzuvae not because it’s a good Scrabble word with the number of “Z” in its name but because of its demonstrated efficacy in two randomized, double-blind, placebo-controlled, multicenter studies. Both compared the use of Zurzuvae (50 mg a day for one study and 40 mg a day for another) versus placebo over the course of 14 days and monitoring what happened for at least four weeks afterwards. Both studies showed that patients getting Zurzuvae experienced significantly greater improvements in scores on the 17-item Hamilton depression rating scale (HAMD-17) compared to placebo at day 15. Not only that, the improvements persisted for four weeks after the last dose of Zurzuvae.

Speaking of “Z’s,” drowsiness is a potential side effect of Zurzuvae. In fact, you may not even realize how drowsy you are, which, as you can imagine, may affect your judgement. That’s why the FDA warns that you “should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.” So if you are thinking of entering that tractor pull or chain saw juggling competition, don’t. Other possible side effects include dizziness, diarrhea, fatigue, inflammation of the upper respiratory passages, and urinary tract infections. Zurzuvae could potentially cause suicidal thoughts and behavior as well. So, it isn’t a medication that you should necessarily take lightly.

The other warning from the FDA is that Zurzuvae could potentially cause harm to your fetus. Therefore, if you are taking Zurzuvae and thinking of baking the potato, checking the oil, bringing an al dente noodle to the spaghetti house, tossing a hot dog down the hallway, or whatever you like to call having sex, use effective contraception throughout and for at least one week after taking Zurzuvae. Effective contraception may mean playing the theme to Law and Order whenever you are with your partner so that you don’t end up having sex at all or using condoms, intrauterine devices, and other combinations of methods since you don’t want to risk getting pregnant again then. Also, hold off on breastfeeding during that period as well so that you may not pass the Zurzuvae along to your infant.

The recommended dose for Zurzuvae is 50 mg once every evening for a total of 14 days. The FDA recommends that you take this medication with a fatty meal not because cheese on cheese can be oh-so-delish. It’s because fat can help the medication be absorbed.

Zurzuvae may not necessarily be like pressing Ctrl+Z on all postpartum symptoms that you may have. It will still be important to get proper support from those around you and appropriate healthcare professionals. Nevertheless, having a new alternative is certainly better than not having a new alternative. Plus, this approval could bring more attention in general to a rather common condition that is unfortunately commonly overlooked.