Spravato® (esketamine) is a newer pharmaceutical that was approved by the United States Food and Drug Administration (FDA) in 2019, to be delivered in a clinical setting as a nasal spray along with an oral antidepressant. As a depression medication, Spravato has demonstrated positive results for patients who were not helped by other medications.
What Is the Depression Medication Spravato?
Spravato (esketamine) is a form of ketamine, a dissociative/hallucinogenic drug that was first synthesized in 1962 and has been used in human and veterinary anesthesia for decades. More recently, there has been a growing body of evidence supporting it’s use for treatment-resistant depression (TRD) and major depressive disorder (MDD), leading to FDA approval in 2019.
Who is eligible? Patients may be eligible for Spravato depression medication treatment if they are at least 18 years old and have a diagnosis of TRD in which they have not experienced meaningful improvement after taking at least 2 antidepressants from different classes for at least 4 weeks each (or, in some cases, 1 antidepressant and psychotherapy), or if they are diagnosed with MDD and have acute suicidal ideation or behavior in addition to depressive symptoms.
How does Spravato work? Spravato is a nasal spray that antagonizes the brain’s N-methyl-D-aspartate (NMDA) receptors to increase levels of glutamate, a neurotransmitter. It is used in conjunction with an oral antidepressant—typically a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).
Spravato is a Schedule III controlled substance that requires special handling under a Risk Evaluation and Mitigation Strategy (REMS). Patients can only take it under medical supervision at a certified treatment center, where they must be observed for at least 2 hours, and someone else must drive them home. This is because Spravato and other forms of ketamine frequently cause sedation and dissociative/hallucinogenic effects, and to prevent drug misuse and abuse. Spravato treatment requires frequent administration, often starting with 2 appointments a week for 4 weeks before declining to weekly appointments and eventually biweekly or less often.
What are the side effects? Spravato’s most common adverse reactions (PDF) include dissociation, dizziness, nausea, vomiting, lethargy, sedation, vertigo, hypoesthesia (numbness), anxiety, euphoric mood, increased blood pressure, and feeling drunk. It causes short-term cognitive impairment and has not been evaluated for long-term cognitive effects beyond one year. Patients cannot drive or operate heavy machinery until the next day following restful sleep. Spravato is only approved for adults and should not be used during pregnancy or breastfeeding due to risk of neurotoxicity.
Behavioral Health Practice Eligibility & Requirements
The drug’s maker, Janssen Pharmaceuticals, has many helpful websites covering how to refer patients to a Spravato treatment center, or how to establish a treatment center in your own practice. For outpatient settings, Janssen offers the choice to receive bulk shipments of the drug or to have patient-specific doses delivered by a pharmacy. There must always be a prescriber at the site, and reliable processes, procedures, and training must be established and maintained to ensure the drug is not misused, all required REMS monitoring paperwork is submitted, patients are educated about the drug and closely monitored for at least 2 hours or longer if medically indicated, and so on. These requirements and more are covered on the Spravato REMS Outpatient Healthcare Setting Enrollment webpage.
How to Apply to Become a Certified Spravato Treatment Facility
The first step to becoming a Certified Spravato Treatment Facility is to “designate an Authorized Representative to oversee implementation and compliance with the REMS requirements.” The SpravatoREMS.com website will guide your behavioral health care practice through the application forms and other requirements. The pharmaceutical company has also provided a 25-minute video featuring 2 practitioners who operate Spravato treatment clinics that may be of help.
Having a solid electronic health records system for your behavioral health care practice can help with managing the additional risks and responsibilities of becoming a Spravato treatment center. At all times, it is important that patients receive clear explanations of the risks, rewards, and costs of Spravato treatment, including the potential side effects and the inconvenience of frequent, lengthy clinic appointments requiring transportation home. In addition, as ketamine is also used as an illicit drug, patient education is key to debunk many false notions patients may have about the drug, and strong security protocols are required to prevent misuse or abuse of the drug by patients and staff.
If you do not want to start your own Spravato treatment center, you may decide to refer patients to an existing treatment center. The “Find a Spravato Treatment Center” map feature of the Spravato for healthcare providers website will help you find nearby treatment centers.
The information provided in this report does not, and is not intended to, constitute legal or medical advice. All information and content available in this report are for general informational purposes only and include links to other third-party websites such as governmental websites and the author’s corporate website. Such links are only for the convenience of the reader. Readers should contact their attorney to obtain advice with respect to any particular legal or medical subject matter.