FDA Approves Spravato for Depression
4 mins read

FDA Approves Spravato for Depression

In March 2019, the U.S. Food and Drug Administration (FDA) marked a significant milestone in the field  of mental health by granting approval to esketamine nasal spray, marketed as Spravato®, for the  treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major  depressive disorder (MDD) accompanied by suicidal thoughts or actions. Esketamine, the S-enantiomer  of ketamine, has a long history of use in medical settings, primarily as a dissociative anesthetic. This  groundbreaking approval has brought renewed hope for individuals battling the most severe forms of  depression.

Understanding Treatment-Resistant Depression (TRD)

Treatment-resistant depression is a complex condition that challenges both patients and healthcare  providers. It is characterized by a lack of response to two or more different antidepressant medications,  leaving individuals in a persistent state of emotional anguish. Current estimates suggest that 30-40% of  people diagnosed with MDD fall into this category, making it a pervasive and daunting issue in the realm  of mental health.

The Enigmatic Mechanism of Esketamine

Esketamine’s mechanism of action is not fully understood, but researchers believe it works by rapidly  increasing the levels of glutamate, a neurotransmitter critical for mood regulation. Unlike traditional  antidepressants that often take weeks to yield noticeable effects, esketamine offers a glimmer of hope  by acting rapidly to alleviate symptoms, particularly in those who have exhausted other treatment  options.

Administration and Treatment Protocol

Esketamine is administered as a nasal spray within a healthcare setting under the watchful eye of a  trained healthcare professional. The typical protocol consists of two doses per week for the first four  weeks, followed by a reduced regimen of one dose per week for another four weeks. Beyond this initial  phase, patients may continue to receive esketamine on a maintenance basis as deemed necessary by  their healthcare provider.

Navigating the Side Effects and Risks

Like many medications, esketamine comes with its set of side effects, albeit typically mild and transient.  These include dissociation, dizziness, nausea, vomiting, headache and sedation. Fortunately, they tend to  resolve within hours of administration.

However, it’s essential to be aware of potential risks. Esketamine can temporarily elevate blood pressure  and heart rate. It may also induce dissociation, which can impair judgment and coordination.  Furthermore, esketamine is classified as a controlled substance due to its potential for misuse and  abuse.

The Implications of FDA Approval

The FDA’s approval of esketamine represents a pivotal moment in the field of depression treatment. It  marks the first approval of a novel antidepressant in decades and brings new hope to individuals who
have faced persistent depressive symptoms without relief from traditional treatments. This development  not only expands the arsenal of available treatments but also signifies a shift toward more innovative  and effective approaches to mental health.

A Comprehensive Treatment Approach

While esketamine offers a promising avenue for treatment, it is essential to recognize that depression  management often requires a multifaceted approach. A sample treatment plan for depression might  include the following components:

Esketamine nasal spray may be used in conjunction with oral antidepressants,  tailored to the individual’s condition, to address TRD or depressive symptoms in adults with  MDD accompanied by suicidal thoughts or actions.


Psychotherapy, such as cognitive-behavioral therapy (CBT), can be invaluable in helping  individuals with depression identify and modify negative thought patterns and behaviors that  contribute to their condition. Combining therapy with medication can often yield the best  results.

•Lifestyle Changes:

Incorporating healthy lifestyle changes can complement medical and  therapeutic interventions. Regular exercise, a balanced diet and adequate sleep can contribute  significantly to mood improvement and the reduction of depressive symptoms.

If you are grappling with depression, it is crucial to engage in open and honest discussions with your  healthcare provider to explore all available treatment options, including esketamine, especially if you  have TRD or are experiencing depressive symptoms with suicidal thoughts or actions. Remember, there  is hope, and new breakthroughs like esketamine offer a ray of light for those on the path to recovery. Are  you a loved one struggling with treatment-resistant depression? Reach out to a professional at Anew Era  TMS & Psychiatry today.

Leave a Reply

Your email address will not be published. Required fields are marked *