Post-Marketing Safety Data for Brexanolone (Zulresso) – News Block

In 2019, the FDA approved brexanolone (marketed by Sage Therapeutics as Zulresso) for the treatment of postpartum depression (PPD). Because preliminary studies indicated that brexanolone may have potentially serious side effects, including excessive sedation and sudden loss of consciousness, the FDA has required a REMS (Risk Assessment and Mitigation Strategy) for health care facilities seeking administer Zulresso. (More information about REMS can be found at According to REMS, patients must be under 24-hour supervision with monitoring by a medical professional on site and continuous pulse oximetry to detect excessive sedation.

Despite considerable enthusiasm for brexanolone as a new and rapidly effective treatment for postpartum depression, REMS-mandated restrictions significantly limited access to brexanolone. A recent study examined postmarketing surveillance data to better estimate the frequency and severity of adverse events reported in adults treated with brexanolone.

A global security database was used for the collection of individual case security reports (ICSR). The investigators analyzed postmarketing surveillance data from a total of 499 patients treated with brexanolone between June 2019 and December 2021. The list of adverse events (AEs) of spontaneous and requested ICSRs was analyzed. The analysis did not include data from clinical trial safety reports. AEs were classified as serious or non-serious as defined by FDA severity criteria. AEs were classified as listed or unlisted, depending on whether or not they were listed on the FDA-approved label for brexanolone.

Serious adverse events were rare

Overall, 137 ICSRs were filed (50 solicited and 87 voluntary), with a total of 396 AEs reported. Of the 17 reported serious AEs, 12 were symptoms of psychiatric illness (eg, suicidal ideation, anxiety). There were two reports of severe AEs of excessive sedation. The remaining three serious AEs included seizures (n=1), hypoxia (n=1), and administration site conditions (n=1). No Reports of loss of consciousness were received.

In total, two serious and one non-serious AE report of excessive sedation was recorded; all cases resolved after stopping the brexanolone infusion and did not require any additional medical treatment. The three reported events of excessive sedation were similar in nature and severity to those previously reported in clinical trials.

In this analysis of postmarketing surveillance data, excessive sedation and unconsciousness when receiving brexanolone occurred at lower rates (<1% (3/499) and 0% (0/499) of patients, respectively). ) than previously reported in completed clinical trials. Also reassuring is the fact that no new security issues were reported. That's good news for patients interested in this treatment; however, there is not yet adequate data to review the REMS that is currently in place.

Ruta Nonacs, MD, PhD


Garafola S, Shiferaw E, Dev V. Safety of brexanolone in adults with postpartum depression: postmarketing surveillance data. Results of drugs in the real world. 2023 June 6.

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