FDA Alert

FDA Approves First Oral Medication for Treatment of Postpartum Depression

Jessica Ganga

The FDA has approved zuranolone to treat postpartum depression (PPD) in adults. The treatment is the first oral medication indicated to treat PPD.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

The approval follows two randomized, double-blind, placebo-controlled, multicenter studies that tested the efficacy of zuranolone. Women who met the criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery were included in the studies.

In the first study, patients received 50 mg of zuranolone or placebo once daily in the evening for 14 days. In the second study, patients received either another zuranolone product that was approximately equal to 40 mg of the approved zuranolone treatment or placebo for the same period of time as the first study. Both studies had a primary endpoint of a change in depressive symptoms in patients using the total score from the 17-item Hamilton depression rating scale.

Patients who received zuranolone showed “significantly more improvement in their symptoms compared to those in the placebo groups.”

According to the FDA press release, the daily recommended dose is 50 mg once every day, for 14 days, and patients are advised to take the dose in the evening following a meal.

The most common adverse effects reported were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.



FDA approves first oral treatment for postpartum depression. News release. US Food and Drug Administration; August 4, 2023. Accessed October 4, 2023.