Spravato® Treatment FAQs

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

    • Adults with treatment-resistant depression (TRD)

    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.cription text goes here

  • In short, treatment-resistant depression (TRD) is a type of depression that doesn’t improve with standard treatments.

  • Esketamine is a more focused, controlled form of ketamine. It works differently from most antidepressants by directly targeting certain areas of the brain that control mood regulation.

  • Coverage for Spravato® treatment depends on your insurance provider, and your individual policy.

    We’re currently accepting BCBS PPO, Aetna, Priority Health, and United Healthcare

    Breaking Through Therapeutics will pre-authorize your treatment, and make sure you understand any out-of-pocket costs.

    Click HERE to download Janssen’s SPRAVATO withME affordability brochure.

  • Spravato® is self-administered as a nasal spray, under the supervision of a healthcare provider, in a healthcare setting.

    All patients will be monitored for at least 2 hours following self-administration of a Spravato® nasal spray treatment.

  • While your exact treatment plan will be determined by you and your provider, Spravato® is generally self-administered twice a week during weeks 1-4 in the induction phase, followed by maintenance treatment once weekly during weeks 5-8, and every 2 weeks or once weekly from week 9 forward

  • Spravato® may cause drowsiness, dizziness, and dissociation. It is advised that you avoid driving, or any activity where you would need to be completely alert.

    Breaking Through Therapeutics requires all patients to have a designated driver for transportation home after receiving treatment.

    Please arrange for a responsible person to accompany you to and from your appointment, or ask about our free transportation service!

  • Patients should not take Spravato® if any of the following apply:

    You are allergic to esketamine, ketamine used for anesthesia, or any other ingredient 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.

  • Spravato® can cause several side effects, most of which are temporary and occur shortly after administration. The most common side effects include:

    • Dissociation: Feeling disconnected from yourself, your thoughts, emotions, space, or time.

    • Dizziness: A sensation of lightheadedness or imbalance.

    • Nausea: Upset stomach or feeling sick.

    • Sedation: Drowsiness or sleepiness.

    • Spinning Sensation: A sense of vertigo or feeling like the environment is spinning.

    • Feeling Drunk: A sensation of intoxication or altered perception.

    • Reduced Sense of Touch and Sensation: A temporary numbing or tingling sensation in the body.

    • Lack of Energy: Feeling unusually tired or fatigued.

    • Increased Blood Pressure: A temporary rise in blood pressure, which can last up to 4 hours after taking a dose.

    • Vomiting: In some cases, patients may experience vomiting following administration.

    These side effects typically appear within 2 hours of taking Spravato® and resolve within 1-2 hours.

    Serious Side Effects

    While uncommon, Spravato® may cause more serious side effects. If you experience any of the following, contact your healthcare provider immediately:

    • Increased Blood Pressure: A significant or sustained increase in blood pressure. Your provider will monitor your blood pressure before and for at least 2 hours after administration. Notify your provider if you experience chest pain, shortness of breath, a sudden severe headache, changes in vision, or seizures.

    • Problems with Thinking or Memory: Difficulty thinking clearly or remembering things.

    • Bladder Problems: Difficulty urinating, frequent or urgent need to urinate, pain while urinating, or waking up at night to urinate.

    Rare Side Effects

    Some rare side effects may also occur, though they are less common. These include:

    • Fainting

    • Anxiety

    • Difficulty Thinking or Remembering

    • Urinary Problems

    Note on Side Effects:

    Unlike traditional antidepressants, Spravato® does not cause side effects like weight gain or decreased libido. It works differently by acting on brain receptors that influence mood, making it a helpful option for people who haven't responded well to other treatments.

  • IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about SPRAVATO®? SPRAVATO® can cause serious side effects, including:

    • Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).

    ◦ Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.

    ◦ Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting

    • Respiratory depression was observed with the use of SPRAVATO®; additionally, there were rare reports of respiratory arrest.

    ◦ Your healthcare provider must monitor you for serious side effects for at least 2 hours (including pulse oximetry) after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.

    • 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.

    • SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, 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.

    • 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.

    • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

    ◦ 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

    Do not take SPRAVATO® if you:

    • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)

    • have an abnormal connection between your veins and arteries (arteriovenous malformation)

    • have a history of bleeding in the brain

    • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.

    If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.

    Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:

    • have heart or brain problems, including:

    ᵒ high blood pressure (hypertension)

    ᵒ slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting

    ᵒ history of heart attack

     ᵒ history of stroke

    ᵒ heart valve disease or heart failure

     ᵒ history of brain injury or any condition where there is increased pressure in the brain

    • have liver problems

    • have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).

    • are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.

     ᵒ Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.

    ᵒ If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.

    ᵒ There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy.

    The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/.

    • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.

    Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.

    Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicine. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

    CLICK HERE to download the official SPRAVATO® Discussion guide.