It was supposed to be a joyous time — the new mother was 42 and had just given birth after a long-awaited pregnancy — but within a week, she developed postpartum depression.
The condition, which is characterised by extreme sadness, anxiety and despair after giving birth, affects one in five women.
Five months after giving birth, the woman was in a state of confusion, said Dr. Misty Richards, medical director of perinatal psychiatry at UCLA Health's Maternal Outpatient Mental Health Services Clinic, who treated the woman and spoke to NBC News about her experience.
“She hadn't showered, she hadn't eaten,” Richards said, adding that the woman's husband had taken time off work to care for his wife and their newborn baby.
Richards, who has treated hundreds of such patients at his clinic, initially referred the woman to an intensive outpatient program, but she continued to have suicidal thoughts while attending, he said.
That's when Dr. Richards prescribed Zuranolone, the first drug used to treat postnatal depression.
The U.S. Food and Drug Administration approved the drug in August, but it took several months for it to become available. Psychiatrists say they are only just starting to write the first prescriptions because it took so long to find eligible patients willing to take the drug. They hope the drug will be a breakthrough because it works quickly and can be taken at home.
Dr. Richards said the woman taking zuranolone was the first of her patients so far to start seeing her depression symptoms subside around day three, and by day eight the patient was experiencing dramatic results and no side effects.
“She said it was like she had woken up,” Dr. Richards said, adding, “It was like meeting her for the first time. Her husband was in tears and so grateful. It's a huge success story, which, by the way, you don't see very often in psychiatry.”
Postpartum depression can have serious effects on mothers and their babies. For mothers, it increases the risk of suicide, high blood pressure, diabetes and stroke. Mental illness, suicide and drug overdose are the leading causes of death among women in the first year after giving birth. Meanwhile, children born to mothers with postpartum depression are more likely to have developmental delays, emotional or behavioral problems and are at higher risk of dying before their first year of life.
Before the development of Zuranolone, the only treatment was an intravenous injection, approved in 2019. But because the drug carries the risk of excessive sedation and sudden loss of consciousness, it is only permitted to be administered at certain treatment centers, and patients must be hospitalized for two and a half days. Other women with the disease are prescribed standard antidepressants, which usually take several weeks to start working. (Zuranolone can be used in combination with other commonly used antidepressants.)
The FDA granted accelerated approval to zuranolone in 2017, a move for drugs that treat serious conditions and have the potential to fill an unmet medical need. Two clinical trials showed that symptoms of severe postpartum depression, including anxiety, sleep problems, loss of pleasure, low energy, guilt, and social withdrawal, improved as early as the third day of taking the drug. The pills are taken daily in the evening with a fatty meal for two weeks.
Doctors say the drug is not appropriate for mild postpartum depression, or the “baby blues,” but rather for patients who are struggling to care for themselves and their babies — patients for whom medical intervention could be lifesaving.
Challenges in Prescribing New Drugs
Despite zurnalone's potential benefits, psychiatrists said some patients are hesitant to take the drug, which is new to the market, because they are wary of side effects or concerned about practical barriers.
Zuranolone can cause drowsiness, dizziness, diarrhea, fatigue and urinary tract infections. So far, doctors say they have heard of patients experiencing drowsiness and dizziness, but nothing extreme.
However, because of this effect, people are warned not to drive or operate heavy machinery for at least 12 hours after taking this drug.
Dr. Urji Haider, medical director of consultation services at the Child Psychiatry Access Program for Mothers in Massachusetts, said some patients worry they will be too tired to feed their baby in the middle of the night, so she encourages them to have a second caregiver at home at night.
“If you have young children and no one is at home at night to look after the baby or other children, it can be very difficult to take medications that can cause severe drowsiness,” she said.
Haider added that other patients refuse to take the drug because of a lack of data on its safety while breastfeeding: Small amounts of zuranolone can pass from mother to child through breast milk, but studies have not evaluated whether that would cause harm.
Recommendation
Richards said she advises new mothers to discard their breast milk while taking zuranolone.
But Dr. Julia Fuller, a psychiatrist at Dartmouth-Hitchcock Medical Center, said the passage of other antidepressants through breast milk has not been shown to pose significant risks, so she thinks the benefits of breastfeeding may outweigh the risks of drug exposure.
“I think continuing to breastfeed while taking this medication is a very reasonable choice,” she says. “Some people may not feel comfortable continuing to breastfeed, and some may want to choose to pump and discard their milk.”
Additionally, Zuranolone is classified as a Schedule IV controlled substance, the same as Xanax, meaning there is a lower risk of addiction.
“I don't think we know enough yet whether it's addictive or not. The hope is that it's not addictive,” said Dr. Katrina Furey, a clinical lecturer in psychiatry at the Yale University School of Medicine.
Patients report improvement
Dr Haider said one of the patients had completed a 14-day course of zuranolone and his condition began improving on the fourth day.
“The only side effect was drowsiness at night, which went away by morning,” she said, adding that women welcomed it because the drowsiness helped them sleep.
Frew similarly said she had one patient who finished taking zuranolone this year. The woman had suffered from chronic depression before she became pregnant, and her symptoms worsened significantly after giving birth. Other medications hadn't cured her symptoms, but zuranolone provided some relief, she said.
But it's not yet known whether zuranolone has a lasting effect: In clinical trials, patients saw results for up to four weeks, but no studies have followed patients for longer than that.
“We don't know yet whether we will need more doses in the future,” Furey said.
“Troublesome and difficult to handle” insurance procedures
Some psychiatrists said they had difficulty getting insurance companies to approve zuranolone.
The medication must be delivered to patients by mail through one of five specialty pharmacies.
“You can't buy Zuranolone at your local CVS,” Haider said.
Insurers also have different requirements for how severe a patient's condition must be before they will cover zuranolone, and some require that a standard antidepressant must first be tried and failed.
“It's a tedious and inconvenient process,” Richards said, adding that many patients don't have the time to wait for issues to be resolved or to actively manage their birth.
“If a patient is severely depressed — and that's why we prescribe zuranolone rather than other medications — it's difficult to ask them to wait out this process and then to engage in this process,” she added.
Despite this, psychiatrists said they were keen to recommend the drug to their patients.
“I started telling all my patients about this,” Furey said, “so they knew this treatment was available and that there was this new option.”
