Regulating Ketamine Use in Psychiatry.

Ketamine is a dissociative anesthetic that has gained attention in the field of psychiatry because of its unique mechanism of action and potential for treating treatment-resistant psychiatric disorders. It has been used off label for decades to treat depression, anxiety, and chronic pain. One of the most significant advancements has been the U.S. Food and Drug Administration’s (FDA) approval of esketamine, the S enantiomer of racemic ketamine, for treatmentresistant depression (TRD) and depression with acute suicidal ideation. Unlike traditional antidepressants, which can take several weeks to start working, esketamine and ketamine can begin to alleviate symptoms within hours of administration. Esketamine is also the only antidepressant of its kind to be studied and approved by the FDA for depressive symptoms in a suicidal population. Over the last five years there has been increased tension among medical providers regarding who is best suited to deliver care with ketamine and esketamine. Although the use of ketamine for depression and other psychiatric conditions has gained increasing attention, there is limited research available to support its use in many of the disorders for which it is used off label. Despite this lack of evidence, ketamine clinics have emerged as a popular alternative for patients who have not responded to traditional treatment options. In addition, the classification of the drug as a Schedule III (CIII) controlled substance and its potential for abuse and dependence raise significant concerns about its safety and appropriate use in medical settings. There is a pressing need for increased research and regulatory oversight into the potential risks and benefits of ketamine as a treatment for multiple psychiatric conditions. As the off-label use of ketamine for psychiatric disorders evolves as a therapeutic option, it is imperative that regulatory authorities promptly establish guidelines and regulations to promote its safe and effective use. This editorial examines the current state of knowledge regarding the use of ketamine and esketamine for psychiatric disorders and presents a framework for thinking through the challenges and opportunities for regulating the use of ketamine in psychiatry.