Implementation of a Hospital-based Brexanolone Program: Erratum

Howard, Margaret M. PhD; Diaz, Zobeida MD, MS; Battle, Cynthia L. PhD

Journal of Psychiatric Practice: January 2023 – Volume 29 – Issue 1 – p. 92

In the summary section of our report, we originally reported that 1 of the 26 patients treated in the program experienced an adverse event of excessive sedation resulting in a pause of the infusion for 30 minutes. However, upon review of the medical chart, it was determined that the patient’s symptoms were not consistent with “excessive sedation” but rather with “sedation,” which is not an adverse event as specified in the REMS protocol. We wish to further clarify that, although a pause of the infusion was not required per the REMS protocol, the medical team opted to pause the infusion as a precaution. Upon resolution of the symptoms, which occurred within 30 minutes, and per patient preference and the medical team’s clinical judgement, a decision was collaboratively made to resume the infusion 1.5 hours later. As noted in the original report, this patient completed her course of treatment without further incident.¹