Two minutes. Straight answer.

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

SPRAVATO may cause serious side effects, including:

• Sedation, dissociation, and respiratory depression. SPRAVATO may cause:
  • sleepiness (sedation) or fainting. 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.
  • a feeling of being disconnected from yourself, your thoughts, your feelings, and space and time (dissociation).
  • difficulty or stopped breathing (respiratory depression or respiratory arrest).

  Your healthcare provider must monitor you for at least 2 hours 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 misuse with SPRAVATO, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment.
  • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
• SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO 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.
• 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.

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 and tell your healthcare provider right away if you develop any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when SPRAVATO is started or when the dose is changed.

Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

• 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

If you're in crisis right now, call or text 988 (Suicide & Crisis Lifeline), or go to your nearest emergency room. Brain Recovery Centers is not an emergency service.

Who should not take SPRAVATO?

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:

• are pregnant or plan to become pregnant. SPRAVATO may harm your unborn baby. You should not take SPRAVATO if you are pregnant.
• are breastfeeding or plan to breastfeed. SPRAVATO passes into your breast milk. You should not breastfeed during treatment with SPRAVATO.

What should I avoid while taking SPRAVATO?

Do not drive, operate machinery, or do activities that require you to be fully alert and coordinated after taking SPRAVATO. Do not take part in these activities until the next day following a restful sleep.

What are the possible side effects of SPRAVATO?

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 FDA at 1-800-FDA-1088.

Read the full Medication Guide (PDF)