It was supposed to be an exciting moment. She had just given birth at the age of 42, after a much-wanted pregnancy. But within a week she developed postpartum depression.
This disorder, characterized by extreme sadness, anxiety or despair after childbirth, affects up to one in five women.
Five months after giving birth, the woman was in a fog, according to Misty Richards, medical director of perinatal psychiatry at the UCLA Health Outpatient Mental Health Services Clinic, who cared for the patient and described her experience. to NBC News.
“He didn't shower. She wasn’t eating,” Richards said, adding that the woman’s husband had taken time off from work to care for his wife and the new baby.
Richards' clinic has seen hundreds of patients with these symptoms. Initially, she referred the woman to an intensive outpatient program, but even while she attended, the patient was actively suicidal, Richards said.
That's when Richards prescribed her zuranolone, the first pill to treat postpartum depression.
The Food and Drug Administration approved the drug last August, but it took months for supplies to become available. Several psychiatrists say they have just started prescribing it because it has taken time to find good candidates willing to take it. They hope it will be a game-changer because it is fast-acting and can be taken at home.
Richards explained that the woman who took zuranolone, the first of his patients so far, saw her symptoms of depression begin to disappear within three days. From the eighth day onwards, the patient began to see spectacular results and did not experience any side effects.
“He tells me he feels like he just woke up,” Richards said. And he added: “I actually feel like I'm meeting her for the first time. Her husband was crying, very grateful. “It is a great success story that, by the way, we do not usually see in psychiatry.”
Postpartum depression can have serious consequences for mothers and their children. In the case of mothers, it can increase the risk of suicide, hypertension, diabetes or stroke. Mental illness, suicide and drug overdoses are the leading causes of death in the first year after childbirth. For their part, children of mothers with postpartum depression are more likely to suffer developmental delays and emotional or behavioral problems, and a higher risk of dying before one year of age.
Before zuranolone, the only treatment available was an intravenous injection approved in 2019. But it carries a risk of excessive sedation and sudden loss of consciousness, so only certain treatment centers are authorized to administer it and patients must remain in the hospital. for two and a half days. Other women with the disease are given standard antidepressants, but these often take weeks to start working. (Zuranolone can be taken along with commonly used antidepressants.)
The FDA fast-tracked zuranolone in 2017, a step taken for drugs that can treat serious diseases 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 – within three days. The tablets are taken daily for two weeks, in the evening with a high-fat meal.
According to doctors, the medication is not ideal for mild postpartum depression. Instead, they are considering it for patients who have difficulty caring for themselves or their babies; in other words, those whose lives could be saved by medical intervention.
Difficulties in prescribing the new pill
Despite zuranolone's potential benefits, psychiatrists say some patients are hesitant to take a new drug on the market, wary of side effects or worried about practical barriers.
Zuranolone may cause drowsiness, dizziness, diarrhea, fatigue, and urinary tract infections. So far, doctors have heard of patients who have experienced drowsiness or dizziness, but not to an extreme degree.
However, because of this effect, the medication comes with a warning not to drive or operate heavy machinery for at least 12 hours after taking it.
Uruj Haider, medical director of consultation services at the Massachusetts Child Psychiatry Moms' Access Program, says some patients have expressed concern about being too tired to feed their babies at night. She recommends that patients have another caregiver at home overnight.
“If you have young children and you don't have anyone at home to take care of the baby or other children at night, it can be very difficult to take a medication that can make you very sleepy,” she said.
Other patients have rejected the drug due to a lack of data on its safety during breastfeeding, Haider added. A small amount of zuranolone can pass from mother to child through breast milk, but studies have not looked at whether it poses any harm.
Richards said she recommends new mothers discard breast milk while taking zuranolone.
But Julia Frew, a psychiatrist at Dartmouth Hitchcock Medical Center, said she suspects the benefits of breastfeeding outweigh the risk of exposure to the drug, especially because transferring other antidepressants through breast milk has not been shown to pose a risk. significant.
“I think it might be a very reasonable option to continue breastfeeding while you're taking it,” she said. “Some people may feel uncomfortable with that, and may want to choose to express the milk and throw it away.”
Additionally, zuranolone is classified as a Schedule IV controlled substance—in the same class as Xanax—which means the risk of addiction is low.
“I don't think we know the addictive potential. There is hope that it is not addictive,” says Katrina Furey, a clinical instructor in the department of psychiatry at Yale School of Medicine.
Patients report improvement
Haider explained that one of his patients completed a 14-day course of zuranolone and that the woman's symptoms began to improve on the fourth day.
“The only side effect was nighttime sleepiness, which disappeared in the morning,” he explained. Haider added that the woman was grateful for the drowsiness because it helped her sleep.
Frew also said a patient had finished taking zuranolone this year. The woman suffered from chronic depression before pregnancy, which worsened significantly after giving birth. Other medications had failed to treat her symptoms, but zuranolone offered some relief, she said.
But it is not yet known whether zuranolone has a lasting effect. In trials, patients saw benefits for up to four weeks, but the studies did not follow up longer.
“We still don't know if people are going to need booster doses later,” Furey says.
A “cumbersome and clumsy” insurance process
Some psychiatrists say they have had problems with the insurance company approval process for zuranolone.
The medication must go through one of five specialty pharmacies and is sent to patients by mail.
“You can't buy zuranolone in a supermarket,” says Haider.
Insurance companies also have different requirements for the severity of patients' symptoms for zuranolone to be covered. Some insurers require patients to have tried a standard antidepressant before and not have had good results.
“It's a cumbersome and clunky process,” says Richards, who adds that many patients don't have time to wait for problems to be resolved or to actively manage their deliveries.
“If someone is severely depressed – and that's why they would be prescribed zuranolone rather than anything else – asking them to wait for this process to unfold and participate in it is difficult,” he added.
However, psychiatrists are willing to recommend the drug to their patients.
“I've started mentioning it to all my patients,” Furey said. “Just so they know it's available and there's this new option.”
