Aug. 10, 2023 – It can be one of the happiest times in a woman’s life – giving birth and meeting a new baby (or babies) face-to-face for the first time. But for about one in seven mothers, postpartum depression takes over, and the joy is short-lived.
For the first time, the FDA has approved a pill, taken once a day for 14 days, to help women manage these often strong, sometimes overpowering symptoms.
WebMD asked several experts in mental health and women’s health to share their take on this new treatment option. What could it mean for easing symptoms like hopelessness, crankiness, and lack of interest in bonding with the baby – and, in some cases, thoughts of death or suicide?
A Fast-Acting Option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism behind postpartum depression, she said.
Zuranolone (brand name Zurzuvae) is different from most other antidepressants – it is designed to be taken for 2 weeks. Also, because zuranolone is a pill, it is more convenient to take than brexanolone (brand name Zulresso), the other FDA-approved treatment, which you get by IV.
“It’s obviously game-changing to have something in pill form,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, and chair of psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
A big reason for that, she said, is because the IV drug has to be given to the patient in a hospital, clinic, or doctor’s office so they can be monitored for complications.
Women may see improvement in postpartum depression as soon as 3 days after starting the medication. In contrast, typical antidepressants can take up to 2 weeks before patients notice a difference, and 4 to 8 weeks to see a full response.
“A fast-acting pill that can be taken orally could be an ideal option for the 15 to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with the University of Pittsburgh Medical Center Western Psychiatric and Magee-Womens Hospital.
The cost of zuranolone is not yet known. Yonkers said the cost of the IV can serve as a cautionary tale for the drugmaker. Some reports put the price of the IV at $34,000. “Cost is going to be an important component to this,” Yonkers said. “The previous intervention was priced so high that it was not affordable to many people.”
Beyond the ‘Baby Blues’
The American Psychiatric Association changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy, but before delivery. No matter when it starts, the condition can be “very serious,” particularly if the person already has depression, including bipolar disorder, Yonkers said.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Gopalan said.
Feelings of exhaustion and frustration are normal with a newborn, but when you start to have a hard time with day-to-day functioning, see yourself withdrawing from life and loved ones, or have thoughts of harming yourself or your baby, these are symptoms of postpartum depression.
Can Be a Medical Emergency
Severe postpartum depression requires attention and treatment right away.
“Any thoughts to harm yourself or others is a psychiatric emergency, and care should be sought out in an emergency setting as quickly as possible,” Gopalan said.
Also, call 988 to connect to your local suicide prevention and crisis hotline if you are having thoughts of harming yourself or your baby.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Yonkers said. “They may need ongoing antidepressants.”
“It may not be the right pill for everybody,” she said. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The Science that Led to Approval
Researchers did two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The Start of More Help for Mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication will likely work best along with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Gopalan said.
Early reaction to the approval of zuranolone on social media was positive, mixed with calls for more support for new mothers beyond medication.
“We can’t let this new pharmaceutical development – which is very exciting and a wonderful addition to the toolbox – distract us from the work that has to be done in terms of advocacy, programming, and support to truly improve the lives of mothers and birthing people in the U.S.,” Oreck said.
Maternal mental health issues like postpartum depression are only compounded by social and political issues that still need to be addressed – like paid leave, disparities in maternal mortality, reproductive rights, and access to mental health care, she said. Health equity is another concern, she added, “Black and brown women continue to have an increased risk of maternal mental health issues and yet are less likely to receive care.”
Oreck hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways, and it’s exciting to finally see research and development dollars dedicated to them.”