SPRAVATO® (esketamine)

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SPRAVATO® is the only FDA-approved nasal spray for treatment-resistant depression (TRD).

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

  • Adults with treatment-resistant depression (TRD)
  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

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.

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About Spravato®

SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It is a first-of-its kind medicine approved by the FDA in two major depressive disorder (MDD) subpopulations with high unmet need.

SPRAVATO® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment resistant depression (TRD) and to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

  • Studied in adults with treatment-resistant depression.*
  • Taken with or without an oral antidepressant.
  • Nasal spray you self-administer under the supervision of a healthcare provider.
  • Tell your healthcare provider if you have a history of drug or alcohol abuse.
  • Greater reduction of depressive symptoms at four weeks† (compared to those who received a placebo and oral antidepressant).
  • In a long-term maintenance-of-effect trial, patients who continued SPRAVATO®‡ treatment were less likely to experience a return of depressive symptoms (known as relapse) compared to those who stopped therapy.
  • After you take SPRAVATO®, a healthcare provider will monitor you for at least two hours during the observation period for possible serious side effects, including feeling sleepy (sedation or loss of consciousness), feeling disconnected from yourself, your thoughts, feelings and around you (dissociation), breathing problems (respiratory depression and respiratory arrest), and increased blood pressure.

* In 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 episode.
† In clinical trials of adults who took SPRAVATO® and an oral antidepressant compared to those who received a placebo and an oral antidepressant. Based on an overall score on a standardized rating scale.
‡ Along with an oral antidepressant.

Important Safety Information

What is the most important information I should know about SPRAVATO®?

SPRAVATO® can cause serious side effects, including:

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.

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.

Because of the risks for sedation, dissociation, 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.

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.

  • 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.

  • thoughts about suicide or dying
  • new or worse depression
  • feeling very agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry or violent
  • an extreme increase in activity and talking (mania)
  • suicide attempts
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

  • 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®.

  • have heart or brain problems, including:
    • high blood pressure (hypertension)
    • 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
  • 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 unborn baby. You should not take SPRAVATO® if you are pregnant.
    • Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
    • If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
    • 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-research-programs/pregnancyregistry/antidepressants/.
    • are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. 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.

  • You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
  • Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
  • Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
  • During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  • You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
  • If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
  • 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 a nasal corticosteroid or nasal decongestant medicine, take these medicines at least 1 hour before taking SPRAVATO®.

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep.

SPRAVATO® may cause serious side effects including:

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.

The most common side effects of SPRAVATO® 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

If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.

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 Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-332-10881-800-FDA-1088.

For more information, visit Spravato.com