It was supposed to be an exciting time. The new mother had just given birth at the age of 42, after a much-desired pregnancy. But within a week, she developed postpartum depression.
This health problem – characterized by extreme sadness, anxiety or hopelessness after giving birth – affects up to 1 in 5 women.
Five months after giving birth, the woman was stuck in a fog, said Dr. Misty Richards, medical director of perinatal psychiatry at the UCLA Health Maternal Outpatient Mental Health Services clinic, who treated the patient and described his experience to NBC News.
“She didn’t take a shower. She wasn’t eating,” Richards said, adding that the woman’s husband took time off work to care for his wife and new baby.
The Richards Clinic has treated hundreds of these patients. At first, she connected the woman to an intensive outpatient program, but even while participating, 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 were just beginning to write their first prescriptions because it took time to find good candidates for the drug who were willing to take it. They hope it will be a game changer because it works quickly and can be taken at home.
Richards said the woman who took zuranolone, the first of his patients so far, saw her depression symptoms begin to resolve about three days later. The patient saw spectacular results from day 8 and experienced no side effects.
“She tells me she feels like she’s waking up,” Richards said, adding, “I really feel like I’m meeting her for the first time. Her husband was in tears, super grateful. Just a success major, a grand slam – which, by the way, we don’t tend to see in psychiatry.
Postpartum depression can have serious consequences for mothers and their children. For moms, it can 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 childbirth. Children born to mothers with postpartum depression, meanwhile, are more likely to have developmental delays and emotional or behavioral problems, and are at greater 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, which is why only certain treatment centers are allowed to administer it and patients must stay in the hospital for 2 1/2 days. Other women with this condition are given standard antidepressants, but these usually take weeks to start working. (Zuranolone can be taken with widely used antidepressants).
The FDA fast-tracked zuranolone in 2017 – a move taken for drugs that could treat serious illnesses and address an unmet medical need. In two clinical trials, it has been shown to improve symptoms of severe postpartum depression, such as anxiety, difficulty sleeping, loss of pleasure, lack of energy, guilt or withdrawal social, from three days. The pills are taken daily for two weeks, in the evening with a fatty meal.
The drug is not ideal for mild postpartum depression, or the “baby blues,” doctors said. Instead, they’re considering it for patients who are having trouble caring for themselves or their babies — in other words, those for whom a medical intervention could save their lives.
Challenges of prescribing the new pill
Despite zurnalone’s potential benefits, psychiatrists said some patients are hesitant to take a drug new to the market, wary of side effects or worried about practical hurdles.
Zuranolone may cause drowsiness, dizziness, diarrhea, fatigue, and urinary tract infections. So far, doctors say they have heard of patients experiencing drowsiness or dizziness, but not to an extreme degree.
However, due to this effect, the medication comes with a warning not to drive or operate heavy machinery for at least 12 hours after taking.
Dr. Uruj Haider, medical director of consultation services at the Massachusetts Child Psychiatry Access Program for Moms, said some patients have expressed concern about being too tired to feed their babies at night. She recommends that patients have another caretaker at home during the night.
“If they have young children and they don’t have anyone at home to watch the baby or other children at night, it can be very difficult to take a medication that can make you very sleepy,” she said. -she declared.
Other patients refused treatment due to lack of data on the safety of breastfeeding, Haider added. A small amount of zuranolone can be passed from mother to child through breast milk, but no studies have evaluated whether it poses any danger.
Richards said she recommends new moms discard their breast milk when taking zuranolone.
But Dr. Julia Frew, a psychiatrist at Dartmouth Hitchcock Medical Center, said she suspects the benefits of breastfeeding outweigh the risk of drug exposure, especially since it Transfer of other antidepressants into breast milk has not 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 this and 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 is a low risk of addiction.
“I don’t think we really know the potential for addiction. There is hope that it is not addictive,” said Dr. Katrina Furey, a clinical instructor in the department of psychiatry at the Yale School of Medicine.
Patients report improvements
Haider said one of his patients underwent a 14-day course of zuranolone and the woman’s symptoms began to improve on the fourth day.
“The only side effect was nighttime sleepiness, which went away in the morning,” she said. The woman enjoyed the sleepiness, Haider added, because it helped her sleep.
Frew also said one patient completed zuranolone this year. The woman suffered from chronic depression before her pregnancy, which worsened significantly after giving birth. Other medications failed to treat her symptoms, but zuranolone provided some relief, she said.
But it is not yet known whether zuranolone has a lasting effect. In trials, patients saw a benefit for up to four weeks, but the studies did not follow people for longer.
“We don’t know yet if people will need booster doses in the future,” Furey said.
A “heavy and clumsy” insurance process
Some psychiatrists reported having difficulty getting zuranolone approved by insurance companies.
The medication must go through one of five specialty pharmacies and be delivered to patients by mail.
“You can’t get zuranolone at your local CVS,” Haider said.
Insurance companies also have varying requirements for the severity of patients’ symptoms for zuranolone to be covered. Some insurers require people to have first tried and failed a standard antidepressant.
“It’s a tedious, tedious process,” Richards said, adding that many patients don’t have time to wait for problems to be resolved or actively manage their deliveries.
“If someone is severely depressed – and that’s why you’re prescribing zuranolone instead of anything else – asking them to wait out this process and then engage in this process, it’s difficult “, she added.
Nonetheless, psychiatrists say they are eager to recommend the drug to patients.
“I started telling all my patients about it,” Furey said. “Just so they know it’s available and they know there’s this new option.”