Is Spravato Therapy FDA Approved?


Spravato therapy is a type of treatment for severe depression that has seen success over recent years. But like many other medications, it comes with a risk of misuse and abuse.

The FDA (Food and Drug Administration) studies the effects and risks of medications to determine whether or not they are safe for medical use. If the FDA determines that a substance is unsafe for widespread consumption, it will be more difficult for patients to obtain the medicine.

So is the use of Spravato therapy approved by the FDA? Keep reading to find out.

What Is Spravato Therapy?

This rapid-acting nasal spray is used for treatment-resistant depression and Major Depressive Disorder (MDD) with suicidal thoughts and/or actions. It is typically combined with an oral antidepressant for complete results. Spravato therapy has the ability to quickly eliminate symptoms of depression, along with any suicidal thoughts. It can also help individuals manage depressive disorders in the long-term.

Is Spravato Approved by the FDA?

Yes, Spravato therapy is approved by the FDA. It was first approved in 2019 for treatment-resistant depression; in 2020, it was approved to treat Major Depressive Disorder. Because of its risks, it took a while for Spravato to officially be approved. However, many steps have been taken to ensure that patients cannot take more than their approved dosage. Spravato can only be administered in a certified healthcare environment and is exclusively available through the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program.

The Process of Spravato Therapy

Patients will usually self-administer Spravato under the supervision of a healthcare professional. After they use the nasal spray, the patient will have to stay at the healthcare facility for about two hours for monitoring. During this time, the professional who supervised the session will look out for any side effects. Potential side effects of Spravato include dissociation (feeling out of body) and sedation (sleepiness, trouble thinking clearly). Therefore, it is important that an individual doesn’t drive or leave the facility until the professional decides that they are able to head home.

Before deciding to take Spravato, you should talk to your doctor to see if it’s the right fit for you. They will take into account your medical history and any current conditions. If you have a history of substance abuse, you may want to consider alternative options for depression treatment. But if your doctor says that you are clear to use Spravato, the rest is then completely up to you.

Starting the Spravato Process

After getting approval from your doctor, you can start researching healthcare facilities near you that offer Spravato therapy. At Elium Health, we offer Spravato therapy in a safe and friendly environment that is dedicated to providing effective mental health treatment. We ensure that all patients feel completely comfortable throughout the entire process of Spravato therapy. Our mental health specialists will check in with you regularly after treatment to discuss progress and will continue to provide any other type of depression treatment as needed.

To learn more about Spravato and our other mental health treatment methods, contact Elium Health by calling us at 866-552-3758 or sending an email to

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