First postpartum depression pill approved by FDA: What to know
September 12, 2023
The medical community has made big strides over the years in increasing awareness and reducing the stigma of postpartum depression (PPD), leading more women to seek treatment. This summer, the U.S. Food and Drug Administration (FDA) approved the first pill specifically designed to treat PPD, which affects 10% to 15% of new mothers.
Symptoms of postpartum depression include a significantly sad or depressed mood, loss of interest in hobbies, feelings of guilt or worthlessness, sleep disturbance, and poor concentration, which can progress to thoughts of harming oneself or the new baby. Symptoms typically begin four to six weeks after delivery, though they can start as late as three months after the baby arrives.
While zuranolone (brand name Zurzuvae) is the first pill for PPD, it is actually the second FDA-approved medication for the condition. Brexanolone, a 60-hour intravenous infusion treatment, was approved in 2019. Since it requires a hospital stay, few women choose to receive it.
Zuranolone pills are taken once a day for 14 days with no hospital stay. Early information about the medication is exciting:
- It appears to work quickly. Studies have shown that zuranolone can start to ease PPD symptoms in just three days, with full effects after two weeks. This is much faster than general antidepressants, which can take a month or longer to start working.
- It’s a new medication class. Zuranolone is being called a neuroactive steroid GABA-A receptor positive allosteric modulator, which works to stabilize hormones instead of serotonin levels like some general antidepressants.
We do not expect zuranolone to be a “wonder drug” that magically cures PPD, which is a complex condition that can be impacted by factors such as socioeconomic stress, relationship tension, and overall maternal health.
But zuranolone may prove to be an important tool in helping new moms feel like themselves again – potentially faster – when the medication becomes more widely available this fall.
5 questions to ask about the new postpartum depression pill
How does the PPD pill work?
We’ve long been using general antidepressants such as selective serotonin reuptake inhibitors (SSRIs), best known by brand-names like Prozac or Zoloft, to help treat PPD by increasing levels of serotonin in the brain. SSRIs work for some patients over time, but for others they have limited effect.
Zuranolone works differently. It contains a synthetic version of allopregnanolone, which is produced by the “pregnancy hormone” progesterone and helps regulate a mood-related neurotransmitter in the brain. Allopregnanolone increases during pregnancy and peaks in the third trimester, then abruptly decreases after childbirth. Zuranolone replenishes allopregnanolone to stabilize hormone function and improve depressive symptoms.
How do I know if zuranolone is a good fit?
Even though zuranolone works specifically on a reproductive hormone, the promising medication might not be right for all new moms with PPD. Here are some important questions to talk through with your health care provider.
Have SSRIs worked for you in the past?
If you’ve found a particular antidepressant was effective for you in the past, you might want to return to that medication instead of trying a new one. If SSRIs have not completely addressed your PPD symptoms in the past, zuranolone could be a better option. It also might be an alternative for women who are reluctant to try antidepressants because of perceived stigmas or because they don’t want to take medication long term.
Are you comfortable taking medication while breastfeeding?
Some new moms may prefer cognitive behavioral therapy (talk therapy) instead of taking medication while breastfeeding. Moms who took part in the Phase 3 clinical trial of zuranolone were asked to stop breastfeeding during the study, so we don’t have data about how much of the medication gets into breast milk or the potential effects of zuranolone on nursing infants.
Breastfeeding moms who want to try zuranolone could continue to pump and discard the milk to maintain their breast milk supply while taking the medication. This is a personal decision and involves weighing the benefits of potentially relieving PPD symptoms with formula-feed for two weeks.
Do you have solid support at home?
Two of the main side effects of zuranolone are drowsiness and dizziness. In new parent terms, that means it will be even tougher to stay awake and care for the baby alone for the two weeks you’re on the medication.
Women who do not have a strong support system at home or who have already returned to work may need to consider cognitive behavioral therapy or another depression medication.
Related reading: Treating postpartum depression with complementary or alternative medicine
PeriPAN program addresses mental health and pregnancy
UT Southwestern is participating in a state pilot program that connects clinicians and psychiatrists who specialize in treating pregnant and postpartum women to expedite mental health care for patients.
Unknowns about the PPD pill
The zuranolone study included 151 women and lasted just 45 days, so it’s currently unclear whether or how long the benefits of medication continue beyond that. If a patient relapses, we will need to determine whether another two-week course of zuranolone might be effective or advisable.
Women in the clinical study who were already taking a different antidepressant were allowed to stay on it, which suggests zuranolone didn’t cause negative interactions. So, we will need to consider when and how to prescribe the new pill in conjunction with other medications.
Manufacturers have not yet said how much zuranolone will cost, so we don’t know how much insurance companies might cover. We also don’t know what restrictions insurance companies might put in place, such as whether patients will be required to try other treatments first. As it stands, health insurance coverage for the postpartum period isn’t universal. Depending on the carrier, coverage may end anywhere between 60 days and a year after giving birth.
Postpartum depression is more common than many women realize, and it is frustratingly random – if it occurs, it is not your fault. Talk with your health care provider if you have PPD symptoms and seek care immediately if you are experiencing suicidal thoughts.
We are hopeful that news of zuranolone’s FDA approval will encourage more women to get treatment for PPD.
To discuss treatment options for postpartum depression, call 214-645-8300 or request an appointment online. If you are experiencing suicidal thoughts, call 911.
