Brexanolone

(Zulresso®)

Brexanolone

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 100 mg/20 mL [5 mg/mL])
Drug ClassNeuroactive steroid gamma-aminobutyric acid modulators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.

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Summary
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  • Zulresso (brexanolone) is indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.
  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Brexanolone significantly improved response and remission rates in postpartum depression (PPD) patients, with effects starting at 24 hours and peaking between 36-60 hours, lasting until Day 7. Zuranolone was also effective in PPD and major depressive disorder (MDD) with higher HAM-D response and remission rates compared to placebo.
  • In PPD, estradiol showed the highest efficacy (SUCRA 94.3%), followed by paroxetine (64.3%) and zuranolone (58.8%), while brexanolone and estradiol were both more effective than placebo.
  • Discontinuing mood stabilizers during pregnancy increased the recurrence of mood disorders in bipolar disorder patients, highlighting the risk associated with discontinuation.
  • Zuranolone in MDD resulted in a higher incidence of adverse events compared to placebo.
  • Brexanolone was associated with higher dropout rates due to tolerability issues, increased risk of sedation or somnolence, and higher rates of discontinuation for any reason.
  • There is no population type or subgroup information available in the reviewed studies.