The Drug Enforcement Administration (DEA) has placed Zulresso (brexanolone; Sage Therapeutics), a treatment for postpartum depression, into Schedule IV of the Controlled Substances Act.

Initially approved in March 2019, Zulresso, an analogue of the endogenous human hormone allopregnanolone, is the first treatment indicated for postpartum depression in adults. According to the DEA “The abuse-related neuropharmacology profile of brexanolone is similar to that of schedule IV substances (alprazolam and midazolam) and consistent with its mechanism of action as a positive allosteric modulator of the GABAA receptors.”

Due to the potential risks of excessive sedation and sudden loss of consciousness, Zulresso is available only through a restricted program called the Zulresso REMS. Under the REMS, only certified pharmacies and healthcare settings can dispense Zulresso. The treatment can only be administered to patients in a medically supervised setting that provides monitoring during administration; patients must be enrolled in the program prior to administration.  

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According to Sage, Zulresso is expected to be available in late June 2019. The product is supplied in 100mg/20mL single-dose vials and is administered as a continuous intravenous infusion.

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