The U.S. Drug Enforcement Administration (DEA) approved a new drug in March 2019 to treat postpartum depression. The drug’s name is brexanolone, and it is marketed as Zulressso by Sage Therapeutics.
On June 17, 2019. the DEA placed brexanolone on Schedule IV of the Controlled Substances Act, the same schedule as benzodiazepines. The reasons for this action included the risk of extreme sedation and sudden loss of consciousness, which can be lethal in some cases. Similar risks have been attributed to benzodiazepines.
In addition to potential side effects, benzodiazepines also cause physiological dependence in some people in as little as 2-4 weeks of continuous use. Withdrawal can cause debilitating symptomology which is often drawn out over months and even years. The primary mechanism of action of benzodiazepines is thought to be the downregulation of GABA-A receptors. Thus, when I read the following statement from the DEA about brexanolone, it caused concern, to say the least.
Brexanolone shares a pharmacological mechanism of action with schedule IV substances such as diazepam and alprazolam and is a positive allosteric modulator of the gamma-aminobutyric acid type A (GABA-A) receptors. — U.S. Drug Enforcement Agency
Unfortunately, placing this drug on Schedule IV does little to raise any serious concern. According to the DEA, drugs on Schedule IV “are defined as drugs with a low potential for abuse and low risk of dependence. ” Anyone who has experienced benzodiazepine withdrawal or worked with benzodiazepine withdrawal patients knows that this language from the DEA is inaccurate, let alone disheartening.
What will it take for the damage done by benzodiazepines, and similar drugs, to be recognized by the mainstream medical establishment? And how do we get our message heard so that new drugs, with a similar propensity for dependence like benzos, stop being approved?
AUTHOR’S NOTE: This story was sent to me by Anne, a long-time friend, and contributor to Benzo Free. Anne prefers to remain in the background for now, but she has been vital in providing research and expert input and I am very grateful for her help.
Han, Da Hee. “Zulresso Approved as First Treatment for Postpartum Depression.” MPR. March 20, 2019. Accessed June 27, 2019. https://www.empr.com/home/news/zulresso-approved-as-first-treatment-for-postpartum-depression/.
U.S. Drug Enforcement Agency. “Drug Scheduling: Drug Schedules.” DEA (Online). Accessed June 26, 2019. https://www.dea.gov/drug-scheduling.
U.S. Drug Enforcement Agency. “Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV.” U.S. Federal Register. Accessed June 27, 2019. https://www.federalregister.gov/documents/2019/06/17/2019-12721/schedules-of-controlled-substances-placement-of-brexanolone-in-schedule-iv.