Spravato

For depressive symptoms, treatment-resistant depression (TRD) in adults.

What is SPRAVATO?

SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

  • Adults with treatment-resistant depression (TRD)

  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. It is not known if SPRAVATO® is safe and effective in children.

How can I get SPRAVATO?

Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.

Requirements:

  • Must be over 18 years old

  • Must have unsuccessfully tried two or more oral meds

  • Must have depressive symptoms

  • Have suicidal thoughts or attempts

What are the Side Effects of SPRAVATO

Sedation
Some individuals may experience drowsiness, feeling sleepy, or decreased alertness after receiving a dose of SPRAVATO®. This sedative effect can occur during the treatment session and may persist for some time afterward.

Dissociation
Dissociative experiences may involve feelings of detachment from oneself, one's surroundings, or reality in general. These experiences can vary widely in intensity and duration, ranging from mild to more profound dissociative states.

Blood Pressure
SPRAVATO® has been known to cause transient increases in blood pressure, particularly in the hours immediately following administration. These increases can be significant and may require monitoring during and after treatment sessions

Nausea or Vomiting
Some individuals may experience these gastrointestinal symptoms during or shortly after receiving a dose of SPRAVATO®. The incidence of nausea and vomiting with SPRAVATO® treatment can vary among individuals, and these side effects may be more common during the initial phases of treatment or with higher doses.

Anxiety
Some individuals may experience these gastrointestinal symptoms during or shortly after receiving a dose of SPRAVATO®. The incidence of nausea and vomiting with Spravato treatment can vary among individuals, and these side effects may be more common during the initial phases of treatment or with higher doses.

What else should I know about SPRAVATO?

SPRAVATO® can cause other serious side effects, including:

  • Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.

    • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children

    • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.

Watching for & preventing suicidal thoughts in yourself and family.

 Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.

  • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.

  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

  • Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

    • suicide attempts

    • thoughts about suicide or dying

    • worsening depression

    • other unusual changes in behavior or mood

Important Safety information:

Discuss any questions you may have with your healthcare provider.

This guide is intended to help you discuss your treatment goals with your healthcare provider and decide together if SPRAVATO® nasal spray is an appropriate treatment option for you. Your healthcare provider is here to answer your questions about treatment, support, safety, and helping you move toward your treatment goals.

*If you are not currently a patient of Battle Creek Family Care, a referral is required from a psychiatrist or psychologist for consideration of treatment. Not all patients qualify for SPRAVATO® treatments.