“Allison’s son tried many oral antidepressants without relief. Now, because of SPRAVATO®, Allison’s son is starting to feel like himself again. “
If you’ve tried two or more antidepressants of adequate dose and duration and are still struggling with depressive symptoms, talk to your healthcare provider to see if you may have treatment-resistant depression. SPRAVATO® works differently than other medications for treatment-resistant depression. Today’s most commonly used oral antidepressants are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood. SPRAVATO® targets the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants. The exact way that SPRAVATO® works is unknown.
In a short-term clinical study of adults with treatment-resistant depression, those who took SPRAVATO and an oral antidepressant experienced a greater reduction of depression symptoms at four weeks compared to those who received a placebo and an oral antidepressant.
In a long-term study after 16 weeks of therapy, patients who stayed on SPRAVATO were less likely to experience a return of depressive symptoms than those who stopped therapy.
See the full efficacy and safety data for SPRAVATO.
In studies of patients with major depressive disorder and active suicidal thoughts or actions, those who took and an oral antidepressant experienced a greater reduction of depressive symptoms at 24 hours compared to those who received a placebo plus an oral antidepressant.* Further reductions were seen consistently through four weeks (25 days) of treatment, so it is important to follow the treatment plan that you and your healthcare provider have made. Not all patients will respond to SPRAVATO®.
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®.
Ask your healthcare provider if SPRAVATO® may be right for you. 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 in children.
Please see Important Safety Information in this brochure. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
Serious side effects of SPRAVATO® include feeling sleepy (sedation); feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation); abuse and misuse; increased risk of suicidal thoughts and behavior; increased blood pressure; problems with thinking clearly; and bladder problems. For additional information on these serious side effects, please see Important Safety Information in this brochure. These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. cp-79822v3 © Janssen Pharmaceuticals, Inc.
Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night
In studies of patients with major depressive disorder and active suicidal thoughts or actions, those who took and an oral antidepressant experienced a greater reduction of depressive symptoms at 24 hours compared to those who received a placebo plus an oral antidepressant.* Further reductions were seen consistently through four weeks (25 days) of treatment, so it is important to follow the treatment plan that you and your healthcare provider have made. Not all patients will respond to SPRAVATO®.
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®.
Ask your healthcare provider if SPRAVATO® may be right for you. 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 in children.
CBS News Miami highlights the positive impact of Spravato on mental health. Michelle Luhau, a patient, shares her experience, describing significant relief and improved daily functioning. Spravato has given her hope and a renewed sense of control over her life.
Your healthcare provider will continue to be involved with your care during SPRAVATO® treatment and will be available to answer questions or address concerns as you undergo treatment.
Your first visit to the certified SPRAVATO® treatment center will be a consultation. The treatment center will:
If SPRAVATO® is recommended, the treatment center will build a treatment plan with you and enroll you in the SPRAVATO® REMS Program.
SPRAVATO® is covered by most insurance and there are ways to help pay for it.
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