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They are part of a patient population that can fall through the cracks in the medical care system. Every year In the United States, it is estimated that more than 400,000 babies are born to individuals who are depressed.
Postpartum depression often goes undiagnosed and untreated. Now, doctors hope the Food and Drug Administration's (FDA) approval of a pill for postpartum depression called Zuranolone (under the brand name Zurzuvae) could raise awareness and increase treatment options for this debilitating condition.
"The approval of Zuranolone is a very exciting development in the treatment of postpartum depression. It adds another option for medication treatment for patients who don't want to use traditional antidepressants," said Lauren Gimbel, MD. Gimbel provides obstetrics and gynecology care to patients at University of Utah Health and is the clinical obstetrical lead of perinatal mental health at U of U Health in collaboration with Huntsman Mental Health Institute.
In studies of Zuranolone, prior to FDA approval, patients with severe postpartum depression reported an improvement in their mood and a reduction in their feelings of depression as early as three days after starting the medication. In fact, Gimbel said, "The improvement in symptoms was seen around two weeks after starting the medication and maintained its effect up to the 45 days it was studied."
"For some patients, the main advantage of Zuranolone may be that it works faster," Gimbel said. Typically, antidepressants can take two to four weeks to show improvement in symptoms. Another novelty to Zuranolone is that the drug is prescribed for a two-week period rather than for months. This makes it easier for patients to comply with directions on how often and for how long to take the medication. It may also improve access as it can be challenging to obtain long-term psychiatric care across the nation.
A similar medication called brexanolone was approved by the FDA in 2019 but required IV administration over a prolonged period and had side effects that required additional monitoring through the Risk Evaluation and Mitigation Strategies (REMS) program. In comparison, during testing of Zuranolone, which is an oral medication, the drug was well tolerated by the patients who took it.
About 16.5% of Utah women who gave birth in 2021 reported experiencing symptoms of depression according to data collected by the Centers for Disease Control (CDC). This is compared to a national average of 12.7%.
An even higher amount, nearly 1-in-3 Utah women, reported depression or anxiety symptoms when including pregnant and postpartum women.
"I think the fact that Zuranolone was developed specifically for postpartum women speaks to how prevalent the condition is and how important it is to develop treatment options that are more accessible to help individuals feel better sooner," Gimbel said.
The approval of Zuranolone may help to lift the stigma surrounding postpartum depression and start a stronger discussion about how to help new parents through this critical period in their lives and the lives of their babies and families.
This is a period of unique changes in an individual's physical and mental health.
"New parents are not sleeping; they are not functioning how they were prior to having a baby. The ways they were able to provide self-care to help manage their mood they are often not able to do because they don't have the time." That plus the change in hormones are unique in the postpartum period, Gimbel explained.
"We know that untreated, perinatal mood and anxiety disorders are associated with negative outcomes for the mother, their partner, and for their offspring. So really for the entire family unit. It impacts quality of life, engagement with medical care, increased use of substances, difficulty with attachment to the infant and long-term developmental risks," Gimbel said.
That's why it's important for mothers to talk about their moods and any depressive symptoms or anxiety that is affecting their ability to function. This discussion is especially critical if they have thoughts of hurting themselves or their baby. It also clears the way for each individual to make choices about their treatment.
"We can talk about everything from conservative options like improving sleep and diet, getting outside, and doing some form of exercise. We can also talk about therapy and for some individuals we talk about medications," Gimbel said. The most effective form of treatment is normally using all these strategies with a combination of therapy and medications being the most effective.
The mortality of the mother is also at risk according to Gimbel.
"The leading cause of maternal mortality (death) in the one-year postpartum is maternal suicide and that really emphasizes the need to talk more about postpartum depression and anxiety both in improving screening that the obstetrics provider does as well as encouraging mothers to talk about their mood and follow up with their provider if they have concerns, so they have access to the care that they need."
Health professionals suggest they can do better in improving screening, diagnosis and treatment of perinatal mood and anxiety disorders. Many believe it will require a collaboration across specialties- the obstetrics provider, psychiatrist, and behavioral health team – as well as a decrease in stigma, cultural expectations, and improvement in access for the women, their family and support systems.
Zuranolone might not be the best option for every individual. Women who have been treated with other medications in the past and responded well may want to use a medication they know worked instead of trying a new medication such as Zuranolone.
During testing of Zuranolone, the studies did not include women who were breastfeeding. So, for now, Gimbel said, "Because we don't know how much of the medication gets into breastmilk, the recommendation is not to breastfeed while taking the medication." The impact of Zuranolone on a mother's breastmilk is just one of several areas Gimbel would like to see further researched.
"I'm hoping what they study next is the long-term response to Zuranolone because it was only studied for 45 days," Gimbel said. "Anytime someone is treated with an antidepressant and has good results, we really try to make sure they have that stability anywhere from 6 to 12 months once their mood is stable. This decreases the chances of reoccurrence."
Zuranolone was developed by Sage Therapeutics and produced in partnership with Biogen. It should be available before the end of the year after a 90-day review that is required of drugs that affect the central nervous system. The companies have not yet announced a price for the pill.
