Health Canada approves 1st pill to treat postpartum depression

Zuranolone is a welcome drug for women suffering from moderate to severe postpartum depression, said Dr. Crystal Clark, Canada Research Chair in reproductive mental health and a psychiatrist at Women’s College Hospital in Toronto.

Selective serotonin reuptake inhibitor antidepressants are often used to treat postpartum depression, but they generally don’t work as quickly and women have to stay on them for much longer, Clark said.

“Although we have treatment options that can be effective for many who have postpartum depression, this will be the first drug that only needs to be taken for two weeks and has a rapid onset of a few days.”

SSRI antidepressants make the neurotransmitter serotonin more available to areas in the brain associated with mood.

Zuranolone is a synthetic version of allopregnanolone — a metabolite of the hormone progesterone, which fluctuates with pregnancy. The drug acts on gamma-aminobutyric acid (GABA) receptors in the brain, which are involved in regulating mood.

Hormonal changes have been linked to the onset of postpartum depression symptoms, Clark said.

The medication is recommended for moderate to severe postpartum depression, with severity measured by the level of impairment in daily functioning, Clark said.

Symptoms can include depressed mood or severe mood swings, severe anxiety or panic attacks, intense irritability and anger, feelings of worthlessness, shame or guilt, difficulty bonding with the baby and overwhelming fatigue beyond the sleep deprivation new parents normally face.

Moms with postpartum depression may also have changes in appetite, trouble getting out of bed, or difficulty showering or getting dressed even when she has help with the baby.

In severe cases, they may have thoughts of not wanting to live, Clark said.

Many of her patients with postpartum depression are “shocked that anything is wrong with them.”

“Some of the comments I hear are, ‘I mean, I wanted this pregnancy, I’m excited about the baby, I don’t know why I feel so bad,'” she said.

In an email to The Canadian Press, Health Canada said it has done a “thorough review” of Biogen’s evidence demonstrating “that the drug meets all criteria for safety, effectiveness and quality, and that its benefits outweigh its risks when used as intended.”

Part of that evidence is a clinical trial that used the Hamilton Rating Scale for Depression to measure the change in symptoms in 196 women with severe postpartum depression. They were randomized to take either zuranolone or a placebo pill once a day for 14 days.

There were “significant improvements” in depressive symptoms among those who took the drug, the study said. The primary measurement was taken after the two weeks of treatment, but some women’s symptoms improved as quickly as three days after starting the medication, it said.

The researchers followed up with the study participants after 45 days and found the symptoms remained reduced.

It’s not known how long those effects will last or if there were any recurrences in depressive symptoms beyond that time period, Clark said, but noted that patients in the United States “are doing well” with the drug.

The most common side-effects among study participants who took zuranolone were drowsiness, dizziness, sedation and headache.

Women should not breastfeed while taking the drug until there is more research to determine whether or not it is safe for the baby, Clark said.

Because of the potential drowsiness, she said, it’s a good idea for women to have someone else with them for the first couple of days to help care for the baby until they see how they react to the medication.

Dr. David Silver, a gynecologic psychiatrist at UPMC in Camp Hill, Pa., has been prescribing zuranolone for more than a year and said it’s been a “very important addition” to the postpartum depression treatment arsenal because it acts quickly.

“When you have a woman who is immediately postpartum with a newborn to take care of, time is of the essence,” he said.

Silver said he looks at his patients’ patterns of depression to decide whether the best treatment is an SSRI antidepressant or zuranolone.

“If they’ve had multiple episodes of depression in the past and they had depression that lasted all through their pregnancy … (and) didn’t just start in the third trimester or the postpartum, well, they may just benefit from (an) SSRI then,” he said.

“On the other hand, if somebody comes in and they are not depressed through the pregnancy and then all of a sudden in the third trimester or in the immediate postpartum (they) develop these pronounced symptoms, well, that person to me is the one that I really am thinking about zuranolone for.”

Eric Tse, general manager of Biogen Canada, said he hopes the drug will be available in Canada starting in the first few months of next year.

In an interview with The Canadian Press, Tse said the company will be working with private insurance providers to secure coverage of Zurzuvae, which costs US$16,000 for the two-week treatment.

He said Biogen may “eventually” negotiate with the public drug sector and that it is establishing a “patient support program” that may help some people who don’t have private insurance and can’t afford to pay out-of-pocket.

This report by The Canadian Press was first published Dec. 9, 2025.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

Nicole Ireland, The Canadian Press

by The Canadian Press

Health Canada approves 1st pill to treat postpartum depression

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