Drug updated on 4/17/2024
| Dosage Form | Capsule (oral; 20 mg, 25 mg, 30 mg) |
| Drug Class | Neuroactive steroid gamma-aminobutyric acid modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of postpartum depression in adults.
Summary
- Zuranolone (Zurzuvae) is indicated for the treatment of postpartum depression in adults. It demonstrates significant improvements in patients with major depressive disorder and postpartum depression, characterized by reduced Hamilton Depression Rating Scale scores and increased response rates.
- The study was based on five systematic reviews/meta-analyses that evaluated the efficacy, safety, and tolerability of Zuranolone compared to other treatments such as brexanolone and traditional medications like estradiol and paroxetine.
- Compared to these alternatives, Zuranolone has proven effective, especially for patients who have not responded well to other treatments. While both estradiol and brexanolone were more effective than a placebo, Zuranolone maintains a competitive stance due to its broader safety profile.
- However, it is important to note that treatment with Zuranolone is associated with an increased incidence of adverse events including somnolence, dizziness, and sedation, which necessitates monitoring during its use.
- In terms of tolerability when compared to brexanolone, Zuranolone's performance varies depending on dose levels but generally falls within acceptable ranges or better, thus making it a somewhat preferable choice.
- Current studies primarily focus on adult populations suffering from major depressive disorder (MDD) or postpartum depression (PPD), with interest in expanding research into diverse population subsets, including children and adolescents. This expansion aims to optimize treatment regimens across different doses and durations, thereby improving overall effectiveness while ensuring patient safety.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zurzuvae (zuranolone) Prescribing Information. | 2023 | Sage Therapeutics, Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis. | 2024 | Frontiers in Neurology |
| Efficacy and safety of zuranolone for the treatment of depression: a systematic review and meta-analysis. | 2024 | Psychiatry Research |
| Efficacy and tolerability of zuranolone in patients with depression: a meta-analysis of randomized controlled trials. | 2024 | Frontiers in Pharmacology |
| 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 |