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FDA approves first oral medication for postpartum depression
Roger Selvage 706

FDA approves first oral medication for postpartum depression

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Postpartum Depression

An exhausted mother breast feeding her baby in somber lighting.

Sonya Collins

In August 2023, FDA approved zuranolone (Zurzuvae), the first oral medication for postpartum depression. Until now, the only treatment specifically for postpartum depression was brexanolone, a 60-hour I.V. infusion administered in a health care facility.

Postpartum depression affects as many as one in five new mothers, typically within the first 6 weeks after giving birth. Untreated, it can prevent mother–child bonding, lead to thoughts of harming oneself or the baby, and result in ongoing depressive disorder for the mother. Treatment can prevent these serious consequences, but stigma and other barriers, such as cost and convenience, have kept many women from seeking care.

This new pill for postpartum depression, a neuroactive steroid, could eliminate some of these barriers.

“It seems to be a game changer,” said Kathleen Vest, PharmD, professor of pharmacy practice at Midwestern University College of Pharmacy in Downers Grove, IL. “As a 14-day oral medication that can be taken in the comfort of your own home—where nobody has to know about it—this becomes a really significant thing that will help improve access. Now it’s just a matter of raising awareness that postpartum does exist and that we have this medication.”

New neuroactive steroid

During pregnancy, levels of the neuroactive steroid allopregnanolone, a metabolite of progesterone, are high. This substance mimics endogenous neurosteroids that are thought to modulate GABA—a relaxatory neurotransmitter that helps regulate mood. After childbirth, allopregnanolone plummets.

“That’s thought to be a contributing factor in the onset of postpartum depression,” Vest said.

Zuranolone mimics allopregnanolone and helps compensate for that sudden drop.

In two double-blind, placebo-controlled clinical trials, women with postpartum depression who took 40 mg to 50 mg of zuranolone every evening for 14 days had significant improvement in symptoms at day 15 compared to women who took the placebo.

“Some of the trials are showing benefit even within the first few days of use,” Vest said.

In the trials, the drug’s effects continued through 42 days of follow-up.

Counseling points

Pharmacists can help raise awareness of postpartum depression and oral therapy among their pregnant patients. “It’s really important to let them know before delivery that this is a significant but common condition and that if they do notice symptoms to report them to their doctor,” Vest said.

Pharmacists may also familiarize themselves with the Edinburgh Postnatal Depression Scale and ask postpartum patients whether they are experiencing any of these symptoms.

“You might say something like, ‘Have you talked with your provider about postpartum depression?’ or ‘Do you mind if I ask you a few questions today?’ ” Vest suggested.

Pharmacists should stress the significant central nervous system depressive effects of the drug, including drowsiness and confusion, to patients who pick up a prescription for zuranolone. Ideally, the 50-mg dose should be taken in the evenings, with fatty foods for optimal absorption, and patients should not drive for 12 hours after their dose. If the depressive effects are too severe, alert patients that health care providers can lower doses to 40 mg per day.

Women may continue to breastfeed while taking zuranolone. According to LactMed, the National Library of Medicine Drug and Lactation Database, very low amounts of the drug are found in breast milk, and it is not expected to cause any adverse effects in breastfed infants.

“Pharmacists can discuss risks and benefits with the patient—of both the clinical need for the medication and also the benefits of breastfeeding,” Vest said. If women are concerned, Vest added, “There’s always the option of withholding breast milk for those 14 days—pumping and discarding for up to a week after.” ■

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