Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 100 mg/20 mL [5 mg/mL]) |
Drug Class | Neuroactive 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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zulresso (brexanolone) Prescribing Information | 2022 | Sage Therapeutics Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The efficacy and safety of some new GABAkines for treatment of depression: a systematic review and meta-analysis from randomized controlled trials. | 2023 | Psychiatry Research |
Comparative efficacy and acceptability of pharmacotherapies for postpartum depression: a systematic review and network meta-analysis. | 2022 | Frontiers in Pharmacology |
Maternal, fetal, and child outcomes of mental health treatments in women: a systematic review of perinatal pharmacologic interventions. | 2021 | Agency for Healthcare Research and Quality |
Brexanolone for postpartum depression: a meta-analysis of randomized controlled studies. | 2019 | Psychiatry Research |