Psychiatrists have started to write the first prescriptions for zuranolone — the first pill to treat postpartum depression.
It was supposed to be an exciting time. The new mother had just given birth at age 42, after a much-desired pregnancy. But within a week, she developed postpartum depression.
The medical condition — characterized by extreme sadness, anxiety or despair following childbirth — affects up to 1 in 5 women.
At five months postpartum, the woman was stuck in a haze, said Dr. Misty Richards, medical director of perinatal psychiatry at the Maternal Outpatient Mental Health Services Clinic at UCLA Health, who treated the patient and described her experience to NBC News.
“She wasn’t taking showers. She wasn’t eating,” Richards said, adding that the woman’s husband had taken a leave of absence from work to care for his wife and new baby.
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Richards’ clinic has treated hundreds of these patients. At first, she connected the woman to an intensive outpatient program, but even while attending, the patient was actively suicidal, Richards said.
That’s when Richards prescribed zuranolone — the first-ever pill to treat postpartum depression.
The Food and Drug Administration approved the drug in August, but it took months for supply to become available. Several psychiatrists said they’re just starting to write their first prescriptions, since it has taken time to find good candidates for the drug who are willing to take it. They hope it will be a game changer because it’s fast-acting and can be taken at home.
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Richards said the woman who took zuranolone, the first of her patients so far, saw her depression symptoms start to resolve around three days in. The patient was seeing dramatic results as of day eight and didn’t experience any side effects.
“She tells me she feels like she just woke up,” Richards said, adding: “I truly feel like I’m meeting her for the first time. Her husband was in tears, super grateful. Just a major, grand slam success story — which, by the way, we don’t tend to see in psychiatry.”
Postpartum depression can have severe consequences for mothers and their children. For moms, it may increase the risk of suicide, high blood pressure, diabetes or stroke. Mental illness, suicide and drug overdoses are the leading causes of death in the first year after a woman gives birth. Children born to mothers with postpartum depression, meanwhile, are more likely to have developmental delays and emotional or behavioral problems, and have a greater risk of dying before one year.
Before zuranolone, the only available treatment was an intravenous injection approved in 2019. But it comes with a risk of excessive sedation and sudden loss of consciousness, so only certain treatment centers are allowed to administer it and patients must stay in the hospital for 2 1/2 days. Other women with the condition are given standard antidepressants, but those usually take weeks to start working. (Zuranolone can be taken alongside widely used antidepressants).
The FDA fast-tracked zuranolone in 2017 — a step taken for drugs that could treat serious conditions and fill an unmet medical need. In a pair of clinical trials, it was shown to improve symptoms of severe postpartum depression — such as anxiety, difficulty sleeping, loss of pleasure, low energy, guilt or social withdrawal — as early as three days in. The pills are taken daily for two weeks, in the evening with a fatty meal.
The medication isn’t ideal for mild postpartum depression, or the “baby blues,” doctors said. Instead, they’re considering it for patients who have a hard time caring for themselves or their babies — in other words, those for whom medical intervention could be lifesaving.
Challenges in prescribing the new pill
Despite the potential benefits of zurnalone, psychiatrists said some patients are hesitant to take a drug that’s new to the market, wary of side effects or concerned about practical barriers.
Zuranolone can cause drowsiness, dizziness, diarrhea, fatigue and urinary tract infections. So far, doctors said they’ve heard of patients experiencing drowsiness or dizziness, but not to an extreme degree.
Because of this effect, however, the medication comes with a warning not to drive or operate heavy machinery for at least 12 hours after taking it.
Dr. Uruj Haider, medical director of consultation services at the Massachusetts Child Psychiatry Access Program for Moms, said some patients have expressed concern that they’ll be too tired to feed their babies at night. She recommends that patients have another caretaker in the house overnight.
“If they have toddlers and they don’t have someone at home to watch the baby or other children at night, that can be very challenging to be on a medication that can make you feel very drowsy,” she said.
Other patients have declined the medication due to a lack of safety data on breastfeeding, Haider added. A small amount of zuranolone can pass from mother to child through breast milk, but studies haven’t evaluated if it poses any harm.
Richards said she recommends that new moms discard their breast milk while taking zuranolone.
But Dr. Julia Frew, a psychiatrist at Dartmouth Hitchcock Medical Center, said she suspects that the benefits of breastfeeding outweigh the risk of medication exposure, particularly since the transfer of other antidepressants through breast milk hasn’t been shown to pose a significant risk.
“I think it could be a very reasonable choice for someone to continue breastfeeding while they’re taking it,” she said. “Some people may be uncomfortable with that, and they may want to choose to pump and dump.”
Additionally, zuranolone is classified as a Schedule IV controlled substance — in the same class as Xanax — meaning there’s a low risk of addiction.
“I don’t think we really know the addictive potential. There’s hope that it’s not addictive,” said Dr. Katrina Furey, a clinical instructor in the Yale School of Medicine’s psychiatry department.
Patients report improvements
Haider said one of her patients has completed a 14-day course of zuranolone, and the woman’s symptoms started to improve by day four.
“The only side effect was the drowsiness at night, and that was gone by the morning,” she said. The woman welcomed the drowsiness, Haider added, since it helped her sleep.
Frew similarly said she has had one patient finish zuranolone this year. The woman had chronic depression before her pregnancy, which got significantly worse postpartum. Other medications had failed to treat her symptoms, but zuranolone offered some relief, she said.
But it’s not yet known whether zuranolone has a lasting effect. In trials, patients saw a benefit for up to four weeks, but the studies didn’t follow people for longer than that.
“We don’t know yet if people are going to need booster doses down the road,” Furey said.
A ‘cumbersome, clunky’ insurance process
Some psychiatrists said they’ve struggled with the process of getting zuranolone approved by insurance companies.
The medication must go through one of five specialty pharmacies and be delivered to patients by mail.
“You cannot pick up zuranolone from your local CVS,” Haider said.
Insurance companies also have varying requirements about how severe patients’ symptoms need to be to get zuranolone covered. Some insurers require people to have tried and failed a standard antidepressant first.
“It’s a cumbersome, clunky process,” Richards said, adding that many patients don’t have time to wait for the kinks to iron out or actively manage their deliveries.
“If someone is severely depressed — and that is the reason you would be prescribing zuranolone instead of anything else — asking them to kind of wait for this process and then to engage in this process, it is hard,” she added.
Nevertheless, psychiatrists said they’re eager to recommend the drug to patients.
“I’ve started telling all my patients about it,” Furey said. “Just so they know it’s available and they know that there is this new option.”
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