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Psych Congress NetworkFDA Approves First Oral Postpartum Depression Treatment, Zuranolone

A New Chapter in Postpartum Depression Care: Introduction of an Oral Medication

The FDA’s recent approval of Zurzuvae (zuranolone) marks a significant advancement in the treatment of postpartum depression (PPD) for adults. This first-of-its-kind oral medication, approved through a fast-track designation, offers a new option beyond the previously available intravenous injection, providing a more accessible treatment for women struggling with this serious condition.

Key Points:

  • FDA approved zuranolone as the first oral medication for PPD treatment.
  • Approval was based on two randomized, double-blind, placebo-controlled, multicenter clinical trials.
  • Participants treated with zuranolone showed significant improvement in depressive symptoms, maintained for at least four weeks post-treatment.
  • Recommended daily dose is 50-mg, taken once daily for 14 days.
  • Boxed warning includes potential effects on driving and hazardous activities, increased risk for at least 12 hours post-dose.

Additional Points:

  • Common side effects: drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, urinary tract infections.
  • May trigger suicidal thoughts and behavior; potential fetal harm necessitates effective contraception during and 1 week post-treatment.


  • The approval of zuranolone introduces a vital new treatment option for PPD, with demonstrated efficacy and specific considerations for patient safety and convenience.

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“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Tiffany R. Farchione, MD
FDA Center for Drug Evaluation and Research’s Director of the Division of Psychiatry
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