FDA Approval of Zuranolone for Postpartum Depression Treatment

by | Jul 8, 2025 | Prescribing tips for treating mental disorders, Recent | 0 comments

In August 2023, the FDA approved zuranolone postpartum depression treatment, a new option for managing symptoms quickly and effectively. What makes zuranolone unique is its rapid onset and short treatment course—just two weeks.

Zuranolone is taken orally and is marketed under the brand name Zurzuvae. You can read the FDA’s official announcement for more details about its approval and clinical use.

Fast Facts About Zuranolone for Postpartum Depression Treatment

  • Pharmacologic category: Antidepressant; GABA A Receptor Modulator
  • Controlled substance: Yes (schedule pending)
  • Approved use: Postpartum depression in adults
    • Note: Not recommended during pregnancy as it was not tested in pregnant individuals
  • Dosage:
    • Standard: 50 mg taken once daily in the evening for 14 days
    • If CNS side effects occur: reduce to 40 mg
    • For hepatic impairment: 30 mg once daily in the evening for 14 days
  • Additional guidance: Take with food containing fat. Can be used alone or alongside oral antidepressants.

Common Side Effects and Duration

Patients may experience:

  • Sleepiness (somnolence)
  • Dizziness
  • Diarrhea
  • Fatigue
  • Nasopharyngitis
  • Urinary tract infections

If central nervous system (CNS) depression develops, dosage adjustments or discontinuation may be necessary.

The full course lasts 14 days, and some patients report improvements within just 3 days. Benefits can extend beyond the treatment period, although long-term relapse data is still being gathered.

How Zuranolone Works

Zuranolone is a synthetic version of allopregnanolone, a neurosteroid derived from progesterone. This neurosteroid helps regulate mood and protects the brain from acute stress.

During pregnancy, estrogen and progesterone levels rise dramatically, then drop sharply after birth. This hormonal shift lowers allopregnanolone levels—something thought to trigger postpartum depression in sensitive individuals.

Zuranolone replenishes allopregnanolone and works by modulating GABA receptors, helping stabilize mood. This makes it a novel and targeted treatment option.

Who Might Benefit from Zuranolone?

Zuranolone isn’t the right fit for everyone. It may not be effective for people with chronic, severe depression that requires long-term management.

However, it’s a good option for:

  • Individuals experiencing postpartum depression for the first time
  • Those who didn’t respond fully to traditional antidepressants

What We Still Don’t Know

There’s limited research on zuranolone’s safety while breastfeeding, as clinical trials focused on non-breastfeeding participants.

Additionally, its final cost and insurance coverage details are still unknown—factors that may influence accessibility.

Why PMHNPs Should Know About Zuranolone

As a psychiatric-mental health nurse practitioner, staying informed about new treatment options like zuranolone helps you offer the best care. With its rapid results and short treatment duration, zuranolone is a promising addition to postpartum depression treatment options.

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