New Oral Medication to Treat Postpartum Depression Approved by FDA

Between 6.5% and 20% of new mothers develop postpartum depression (PPD), though many more may go undiagnosed. PPD symptoms may include: 

  • Depressed mood or severe mood swings 
  • Difficulty bonding with their baby 
  • Withdrawing from family and friends, loss of appetite, or insomnia 
  • Loss of energy or reduced interest and pleasure in activities they used to enjoy 
  • Intense irritability, anger, anxiety, and panic attacks 
  • Fear that they’re not a good mother 

Recommended course for NPs: Clinical Series Episode: Moms’ Mental Health: Understanding Perinatal Depression 

On August 4, 2023, the FDA approved Zurzuvae (zuranolone), an oral medication to treat PPD in adults. Though treatment for PPD had previously been available via IV injection given by a healthcare provider in certain healthcare facilities, Zurzuvae is the first FDA-approved oral treatment.  

“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,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.” 

In clinical trials, participants were women with PPD who met the DSM-5 criteria for a major depressive episode with symptoms beginning in the third trimester or within four weeks of delivery. 

According to the FDA’s press release, patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at Day 42 — four weeks after the last dose of Zurzuvae. 

Among trial participants, the most common side effects of the drug include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection. 

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