Just a few years ago, esketamine was approved by the US Food and Drug Association (FDA) to be used for treatment-resistant depression. Spravato® nasal spray is the only approved method of delivery for esketamine.
What is Spravato®?
Esketamine is closely related to ketamine. Like ketamine, this drug works by binding to NMDA receptors in the brain, which blocks the reuptake of glutamate and activates AMPA receptors. These actions strengthen the synapses in the brain associated with motivation and mood.
Spravato® is used for treatment-resistant depression, which means that patients must have tried at least two other oral antidepressants, and they failed to alleviate symptoms.
It may also be used for patients with major depressive disorder with acute suicidal ideation. Unlike oral antidepressants, Spravato® can alleviate symptoms in hours rather than weeks, which makes it an ideal treatment for individuals who require immediate clinical intervention.
Spravato® treatment center?
Legally using Spravato® requires the patient to seek treatment from a certified Spravato® treatment center. These centers are REMS-certified, which means they comply with the Risk Evaluation and Mitigation Strategy (REMS) that manages known or potential risks of a drug. In addition, it is FDA required to ensure that the benefits of drug administration outweigh its risk.
These risk evaluations are required because Spravato® treatment plans and administration of esketamine do carry some risks, such as:
The most common psychological effect of Spravato® use is dissociation or perceptual changes, which may include the distortion of time, space, and illusions.
Some patients taking Spravato® may experience sedation or a loss of consciousness. Due to this risk, a healthcare provider often monitors patients for at least two hours at each treatment session. In addition, these sessions are usually followed by an evaluation to determine that the patient is clinically stable enough to leave the Spravato® treatment center.
Abuse and misuse
Like ketamine, esketamine is a Schedule III controlled subject that is subject to abuse and diversion. As such, patients are monitored for developing these behaviors or conditions, which may include drug-seeking behavior. Trained clinicians will reassess patients periodically for signs of abuse or dependence.
Suicidal thoughts or behaviors in adolescents
Spravato® may potentially increase the incidence of suicidal thoughts.
Increased blood pressure
Spravato® increases systolic and diastolic blood pressure at all recommended doses. Increases in blood pressure peak between 40 minutes and 4 hours after drug administration.
Short-term cognitive impairment may occur after receiving Spravato®.
Because of the risks that come with taking Spravato®, patients should be assessed to determine whether the drug is the best option for treatment.
What to expect at a Spravato® treatment center?
Spravato® represents a very new way to treat depression for patients that have had little success with traditional methods. For this reason, many patients do not know what to expect when visiting a certified Spravato® treatment center.
Before receiving treatment, staff at a certified treatment center will complete a comprehensive evaluation to determine if Spravato® is the best option for your unique symptoms and circumstances.
Spravato® treatment centers can assist with prior authorization, questions about your insurance company or coverage, and administration. They may also review the medication guide with you and provide an overview of center operations and what to expect during your first treatment session.
On the day of your first treatment, there are several things to consider, such as:
Plan for the appointment
Your clinician should provide instructions for your first appointment. These instructions include fasting for at least two hours before your scheduled arrival and avoiding liquid ingestion for at least 30 minutes before your appointment. Spravato® may cause nausea or an upset stomach in some patients. You may want to bring headphones to listen to music to help you relax during the session.
Arrive for the appointment
Once you arrive, let the receptionist know you are there, and they will notify the appropriate clinician who can take you to the treatment room and help you get comfortable.
Before the clinician administers Spravato®, a psychiatric provider will speak to you to determine your readiness for treatment.
Your blood pressure will be checked
Because Spravato® increases blood pressure, a baseline blood pressure reading will be taken to ensure it is acceptable for Spravato® administration.
You will receive your dose in two to three parts
Spravato® is administered nasally in two to three doses during most treatment sessions but only two during the first session. These doses are administered five minutes apart.
Monitoring of your vital signs
Once Spravato® has been administered, there is nothing to do but wait for the next two hours. The clinicians will periodically check your blood pressure to determine if it is acceptable. Clinicians are also on-hand to address any concerns or side effects you may feel after administration of Spravato®.
Clearance and conclusion of the treatment
After two hours, the clinician will assess you for signs of impairment. If you don’t have any, you are cleared to leave, although patients cannot drive for 24 hours after treatment.
If you experience any side effects after leaving the certified Spravato® treatment center, you will want to call your healthcare provider and discuss them as soon as possible. Spravato® can be life-changing for many patients who have unsuccessfully been trying to alleviate their symptoms of depression. To determine if Spravato® is right for you, contact your nearest Spravato® treatment center and make an appointment.