It has been a few months since Zulresso (brexanolone), the new FDA-approved treatment for postpartum depression, has been available. At our clinic, we have had multiple queries regarding how to obtain treatment with Zulresso. One of the challenges in rolling out Zulresso is that, because of concerns about potentially serious side effects, it can only be administered at certified healthcare facilities. We do not have a list of these facilities; however, Sage Therapeutics maintains a toll-free number to help clinicians and patients find certified health care facilities: 1-844-472-4379.
The Cleveland Clinic and Hillcrest Hospital will be offering brexanolone through a pilot program and, in this article, discusses some of the challenges this clinic has faced in rolling out this innovative treatment for PPD. Zulresso must be delivered as an intravenous infusion over 60 hours, which means that patients must be hospitalized for about three days. While some psychiatric hospitals are able to handle medical issues (including the administration of IV drugs and monitoring for side effects), many psychiatric hospitals do not have this capacity. The pilot program at the Cleveland Clinic is being conducted within the Department of Obstetrics.
Because Zulresso may have potentially serious side effects, including excessive sedation and sudden loss of consciousness, the FDA requires a REMS (Risk Evaluation and Mitigation Strategy) for healthcare facilities seeking to administer Zulresso. More information on the REMS can be found at www.zulressorems.com. According to the REMS, patients must be under 24-hour supervision with monitoring by an on-site medical professional and continuous pulse oximetry to detect excessive sedation. In this pilot program, the mother can be hospitalized with her baby, if a family member is available to help care for the baby. Breastfeeding, however, is not permitted during the Zulresso infusion.
This is an exciting new chapter in the treatment of postpartum depression, and we are eager to have and to try out this new treatment. If you are a provider or patient who has used Zulresso, please feel free to share your experiences with us.
Ruta Nonacs, MD PhD