What is Spravato?

Spravato is the brand name for esketamine, a nasal spray medication that’s chemically related to ketamine, an anesthetic in use for many years. It was developed by Janssen, a pharmaceutical company, and approved by the U.S. Food and Drug Administration (FDA) in 2019.

Spravato is specifically indicated, in conjunction with an oral antidepressant, for treating:

• Treatment-resistant depression (TRD) in adults.
• Depressive symptoms in adults with major depressive disorder (MDD) who have a current suicidal ideation or behavior.

Notably, the use of esketamine is distinct from the use of ketamine in various medical and non-medical settings. Spravato is administered under a healthcare provider’s supervision in a certified healthcare facility due to the potential for serious side effects and the need for monitoring. It can cause sedation and dissociation shortly after administration, and patients are typically monitored for a couple of hours after receiving a dose.

Spravato’s approval was seen as a significant advancement in the field of psychiatry due to the unique mechanism of action it has compared to other available antidepressants. However, its use is also associated with some concerns, precautions, and potential side effects, which is why it’s administered under controlled conditions and with strict monitoring.

Key Takeaways:

• Spravato is a prescription medication for treating treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal thoughts or actions.
• It is used in conjunction with an oral antidepressant.
• Spravato contains esketamine, a more potent version of ketamine.
• Esketamine increases glutamate levels in the brain to improve communication between brain cells.
• Spravato is administered as a nasal spray in a certified medical office or clinic.

How does Spravato work?

Spravato contains esketamine, a more potent version of ketamine, and works by increasing levels of glutamate in the brain to promote better communication between brain cells. This mechanism of action is thought to contribute to the antidepressant effects of Spravato in individuals with treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal thoughts or actions.

Esketamine, as a glutamate receptor modulator, targets the N-methyl-D-aspartate (NMDA) receptor, which plays a crucial role in regulating glutamate activity in the brain. By binding to this receptor, Spravato helps activate specific circuits responsible for mood regulation and cognition. This activation releases different neurochemicals that can reduce depressive symptoms and improve overall mental well-being.

In addition to its direct effects on glutamate activity, Spravato also influences the production of brain-derived neurotrophic factor (BDNF). BDNF is a protein that supports the growth and survival of neurons in the brain, and its levels are lower in individuals with depression. By increasing BDNF levels, Spravato promotes the growth of new connections between brain cells, a process known as neuroplasticity, which may contribute to the long-term benefits of the medication.

However, it is important to note that the precise mechanisms underlying Spravato’s antidepressant effects are still being studied. Ongoing research and clinical trials are aimed at further understanding how this medication works and how it can be optimized for the treatment of depression.

Key Points:

Spravato contains esketamine, a more potent version of ketamine.

It works by increasing levels of glutamate in the brain.

Activation of specific brain circuits helps reduce depressive symptoms.

Spravato also influences the production of brain-derived neurotrophic factor (BDNF).

Who is Spravato intended for?

Spravato is specifically approved for treating treatment-resistant depression (TRD) and major depressive disorder (MDD) with thoughts or actions of suicide. It is a prescription medication that can be used with an oral antidepressant to provide relief for adults who have not responded to other antidepressant medicines.

Spravato contains esketamine, a more potent version of ketamine, and works by increasing levels of glutamate in the brain. This helps to promote better communication between brain cells and can alleviate depressive symptoms. However, it is important to note that Spravato is not meant for everyone and should only be used under the guidance of a healthcare provider.

Due to the risk of serious side effects such as sedation and dissociation, Spravato must be administered in a certified medical office or clinic and cannot be taken home. It is available only through a restricted distribution system to ensure proper supervision by healthcare professionals. Regular monitoring and assessment are necessary to determine the effectiveness of treatment and manage any potential side effects.

How is Spravato administered?

Spravato is administered as a nasal spray, and a healthcare provider determines the dosage. The nasal spray format allows for easy and convenient administration, providing a non-invasive option for patients. The healthcare provider will guide you on the proper technique for using the nasal spray to ensure the effective delivery of the medication.

During the administration process, you will be required to remain in the certified medical office or clinic for at least two hours after each dose for monitoring. This is necessary due to the potential side effects of Spravato, such as sedation and dissociation. The healthcare provider will closely monitor your vital signs and overall condition to ensure your safety.

Benefits of Spravato Nasal Spray Administration:

Easy and convenient to use

Non-invasive administration method

Closely monitored by healthcare provider

Reduced risk of oral ingestion errors

It is important to note that Spravato cannot be taken home for self-administration. It is only available through a restricted distribution system to ensure proper supervision and monitoring. The healthcare provider will work closely with you to determine the appropriate dosage and treatment schedule based on your specific needs and response to the medication.

Where can Spravato be administered?

Spravato must be administered in a certified medical office or clinic and cannot be taken home. Due to the potential for serious side effects and the need for close monitoring, the administration of Spravato is restricted to healthcare professionals in a controlled environment.

The certified medical office or clinic should have the necessary equipment and trained staff to provide the prescribed dosage safely. This ensures that the patient receives appropriate care and supervision during administration.

It is important to note that Spravato is unavailable for self-administration or home use. This restriction is in place to prevent misuse and to minimize the risk of adverse events. The healthcare provider will administer the medication through a nasal spray device, following the prescribed dosage and administration guidelines.

In summary, if you are considering Spravato treatment, it is crucial to consult with a certified medical office or clinic where qualified professionals can administer the medication in a controlled setting. This helps ensure your safety and well-being throughout the treatment process.

Are there any side effects of Spravato?

Common side effects of Spravato may include dizziness, nausea, sedation, and increased blood pressure. While these side effects are generally mild and temporary, it is important to be aware of them. Your healthcare provider will closely monitor you during and after each Spravato treatment session to ensure your safety and well-being.

In rare cases, more severe side effects may occur, such as dissociation, a detachment from reality or oneself. This can manifest as feeling disconnected from your surroundings or experiencing a sense of unreality. You must inform your healthcare provider if you experience any unusual or concerning symptoms during or after receiving Spravato.

Spravato is a controlled substance and is classified as a Schedule III drug. This classification is due to the potential for dependence and misuse. It is essential to follow your healthcare provider’s instructions and not exceed the recommended dosage or frequency of Spravato treatment. Abuse or misuse of Spravato can lead to serious health risks.

Common Side Effects	Rare Side Effects
DizzinessNauseaSedationIncreased blood pressure	Dissociation

Is Spravato a controlled substance?

Spravato is classified as a Schedule III controlled substance due to the risk of dependence and potential for misuse.

This classification means that certain regulations and restrictions surround its prescription and use. Spravato cannot be obtained without a valid prescription from a healthcare provider, and it must be stored securely to prevent unauthorized access.

As a Schedule III drug, Spravato is considered to have a moderate to low risk of physical or psychological dependence compared to Schedule I or II drugs. However, it still carries a potential for abuse, which is why healthcare professionals closely monitor it.

If you are considering using Spravato as part of your depression treatment, follow your healthcare provider’s instructions precisely and communicate any concerns or questions you may have regarding its controlled substance status. Your healthcare provider will be able to provide you with the necessary guidance and information.

Can insurance cover Spravato?

Insurance coverage for Spravato may vary depending on your specific insurance plan and provider. Some insurance companies may cover the cost of Spravato, while others may require prior authorization or have certain restrictions in place. It is important to contact your insurance company directly to understand what coverage options are available to you.

If you are concerned about the cost of Spravato, financial assistance programs may be available to help eligible individuals. These programs can assist with the out-of-pocket costs associated with the medication. For example, Spravato offers a patient assistance program that provides financial support to eligible patients who meet certain income and other criteria.

In addition to financial assistance programs, your healthcare provider may be able to provide guidance and resources to help you navigate the insurance coverage process and explore other potential avenues for financial assistance. They can work with you to determine the best course of action based on your circumstances.

Conclusion

Spravato is a cutting-edge treatment for depression that combines esketamine with an oral antidepressant to address treatment-resistant depression and major depressive disorder with suicidal thoughts or actions. Spravato, a prescription medication, is specifically approved for adults who have not responded to other antidepressant medicines.

Spravato works by increasing levels of glutamate in the brain, promoting better communication between brain cells. It is administered as a nasal spray in a certified medical office or clinic under the supervision of a healthcare provider. Due to the risk of serious side effects such as sedation and dissociation, Spravato cannot be taken home and is only available through a restricted distribution system.

While Spravato has shown positive results in clinical trials, long-term studies are still ongoing to further assess its safety and effectiveness. It is important to note that Spravato is classified as a controlled substance and is categorized as a Schedule III drug due to the risk of dependence and potential for misuse.

Insurance coverage for Spravato may vary, and financial assistance programs may be available for eligible individuals. If you or a loved one are struggling with treatment-resistant depression or major depressive disorder, consult with a healthcare provider to determine if Spravato is a suitable treatment option.

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