Spravato Treatment

What is treatment-resistant depression?

In the SPRAVATO® clinical trials, treatment-resistant depression was diagnosed in adults who were struggling with major depressive disorder and had not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.

How is Spravato nasal spray different than ketamine infusion?

SPRAVATO® (esketamine) CIII nasal spray is a derivative of ketamine. SPRAVATO® is an FDA-approved nasal spray for treatment-resistant depression; it is also approved to treat depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions. Ketamine has not been approved by the FDA to treat depression. Both SPRAVATO® and ketamine are Schedule III controlled substances under the US Controlled Substances Act.

What side effects could I experience on SPRAVATO®

Other possible serious side effects include increased blood pressure, problems with thinking clearly, and bladder problems. The most common side effects include feeling disconnected from yourself, your thoughts, feelings, and things around you (dissociation); dizziness; nausea; feeling sleepy (sedation); spinning sensation; decreased feeling of sensitivity (numbness); feeling anxious; lack of energy; increased blood pressure; vomiting; feeling drunk; and feeling very happy or excited.

Serious side effects reported with SPRAVATO® include sedation and dissociation, and there is a risk of abuse and misuse with SPRAVATO®. There is an increased risk of suicidal thoughts and behavior with SPRAVATO®. Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or behavior.

Because of the possibility of nausea and vomiting, you should avoid eating two hours before, and drinking liquids 30 minutes before, taking SPRAVATO®.

Who should not take SPRAVATO®?

Do NOT take SPRAVATO® if any of the following applies to you:

You are allergic to esketamine, a similar medicine called ketamine used for anesthesia, or any of the other ingredients in SPRAVATO®.

You have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation) or a history of bleeding in the brain.

Be sure to tell your healthcare provider if you have heart, brain or liver problems; if you have psychosis; or if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take SPRAVATO® if you are pregnant. You should not breastfeed if you are taking SPRAVATO®.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Are there any activities I should not engage in after SPRAVATO® treatment?

You should discuss your plans for the remainder of the day with your healthcare provider. Because of possible side effects affecting mental alertness and motor coordination, you won’t be able to drive, operate machinery or do anything where you need to be completely alert until the day after a treatment session, following a restful sleep, even if you think you feel well enough to do so. Because of this driving restriction, you will need to plan for your rides on treatment days.