Spravato®

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.

You cannot take SPRAVATO® on your own. You will administer SPRAVATO® nasal spray yourself in our office. Because of the risks for sedation or loss of consciousness, dissociation, respiratory depression, and abuse and misuse, SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program.

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.

At each visit, we will ask about your symptoms of depression, side effects and whether or not you are experiencing noticeable improvement. In the clinical studies of SPRAVATO®, a standardized scale called the Montgomery-Åsberg Depression Rating Scale was used to track treatment-resistant depression symptoms and response to treatment.

The most common side effects of Spravato are dizziness, headache, nausea, and sleepiness. These usually go away after a few days as your body adjusts to the medication but you will still need to adhere to a 24-hour supervision period following each dose.

Spravato can also cause dissociation, which is when you feel disconnected from your body or surroundings. This can include feeling out of control, feeling like you are floating, or feeling like you are in a dream. These effects usually go away after the medication wears off but can make it hard to drive or operate machinery. For this reason, you will need to have someone drive you home after your first dose of Spravato and after each dose for at least 24 hours.