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Important Safety Information for Spravato® (Esketamine)

A man walking on a path to feeling better, inside the silhouette of a person's head
What is the FDA-approved use of Spravato®?

Spravato® (esketamine) is a prescription medicine FDA-approved for the following uses in adults:

  • Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant.
  • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.
Who should not use Spravato®?

People with the following conditions should not use Spravato®:

  • Aneurysmal vascular disease or blood vessel disease including thoracic and abdominal aorta, intracranial and peripheral arterial vessels. 
  • Arteriovenous malformation which is an abnormal connection between your arteries and veins. 
  • Intracerebral hemorrhage or bleeding in your brain.
  • Allergy or Hypersensitivity to esketamine, ketamine, or any of the ingredients in Spravato®
  • Pregnancy

People with the following conditions may be at increased risk for adverse events and side effects:

  • High blood pressure (hypertension)
  • Cognitive Impairment
  • Certain cardiovascular and cerebrovascular conditions such as:
    • slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
    • history of heart attack
    • history of stroke
    • heart valve disease or heart failure
    • history of brain injury or any condition where there is increased pressure in the brain
  • Liver problems
  • A history of psychosis or seeing, feeling, or hearing things that are not there, or believe in things that are not true, or a first degree relative with schizophrenia.

Spravato® should not be used in children.

How should I take Spravato®?
  • Some people taking Spravato® get nausea and vomiting. You should not eat for at least 2 hours before taking Spravato® and not drink liquids at least 30 minutes before taking Spravato®.
  • If you take nasal decongestant or corticosteroid medications, take these medications at least 1 hour before taking Spravato®.
  • The Spravato® nasal spray will be self-administered in our practice under the supervision of a healthcare provider.  We will show you how to use the device.  You will spray the indicated dose in each nostril and will then be monitored in our setting for two hours.
  • During and after each use of Spravato®, you will be observed and monitored by a health care provider in our practice who will decide when you are ready to leave.
  • We strongly encourage someone to escort you home after the session.
What should I tell my provider before using Spravato®?
  • You should tell your provider about your medical history, including but not limited to the ones listed above.
  • Make sure to indicate all of the medications that you take including prescription and over-the-counter medicines, vitamins and herbal supplements so that we can look for potential drug interactions before your first session.  
    • Be sure to always update your provider if you are put on new medications or supplements during the course of your treatment. 
    • Medications which are particularly important to disclose given the risk of side effects are: central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs).
  • If you are pregnant or planning to become pregnant, discuss this with your provider.
  • If you become pregnant during the course of Spravato® treatment, tell your provider right away. Spravato may cause fetal harm.
    • 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 here.
What are the most serious side effects that I or a caregiver should monitor for when taking Spravato®?
  • Increases in Blood Pressure. 
    • Spravato may cause temporary spikes in blood pressure. We will monitor this during your treatment. 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®.
  • Cognitive Impairment, and specifically, impairment of attention, judgment, thinking, reaction speed and motor skills, or not being able to think clearly.
  • Sedation, dissociation, and respiratory depression. 
    • Spravato® may cause you to feel sleepy, faint, anxious, disconnected, dissociated, and sometimes give you breathing problems (respiratory depression and respiratory arrest).
  • Spravato may cause fetal harm. Consider pregnancy planning and prevention in people of child bearing age.
  • Bladder problems 
    • Signs may include trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
  • Impaired Ability to Drive and Operate Machinery: 
    • Do not drive or operate machinery until the next day after your Spravato treatment.
  • Potential for Abuse and Misuse
    • There is potential for abuse and misuse of this medication.  As a result you should disclose a history of alcohol and substance dependence (including prescription pills) before your treatment.
  • Increased Risk of Suicidality
    • It may increase suicidal thoughts and actions in some people, and cause mental health effects. 
    • If you feel any sudden changes in mood, behavior, thoughts, or feelings alert your health care provider immediately and be sure to inform a family member who can help you.
      • Examples include: 
        • Trouble sleeping (insomnia)
        • Worsening depression or anxiety
        • An extreme increase in activity and talking (mania)
        • Feeling very agitated or restless or more irritable than usual
        • Panic attacks
        • Thoughts about dying
        • Acting aggressive, being angry or violent
        • Acting on dangerous impulses
        • Suicidal thoughts or self-injurious behavior
      • If you develop suicidal thoughts, call 911 or 988 or go to your nearest emergency room.

Because of the risks associated with Spravato® use, it is only available through a restricted program called the Spravato® Risk Evaluation and Mitigation Strategy (REMS). Spravato® can only be administered at healthcare settings certified in the Spravato® REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program.

What are the most common side effects of Spravato®?

The most common side effects of Spravato® usually occur right after and on the same day of receiving Spravato® treatment and include:

  • Feeling disconnected from yourself, your thoughts, feelings and things around you
  • Dizziness
  • Nausea
  • Feeling sleepy
  • Spinning sensation
  • Decreased feeling of sensitivity (numbness)
  • Feeling anxious
  • Lack of energy
  • Increased blood pressure
  • Vomiting
  • Feeling drunk
  • Headache
  • Feeling very happy or excited

This information is not comprehensive. Please see the full Prescribing Information for complete safety information. You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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