IMPORTANT WARNING:

• Using esketamine nasal spray may cause sleepiness (sedation); fainting; dizziness; anxiety; a spinning
  sensation; or feeling disconnected from your body, thoughts, emotions, space and time; and breathing
  problems.
• You will use esketamine nasal spray by yourself in a medical facility, but your doctor will
  monitor you before, during, and for at least 2 hours after your treatment.
• You will need to plan for a caregiver or family member to drive you home after using esketamine.
• After you use esketamine nasal
  spray, do not drive a car, operate machinery, or do anything where you need to be completely alert until the next day after a restful night’s sleep.
• Tell your doctor right away if you experience any of the
  following symptoms: extreme tiredness or sleepiness, dizziness, fainting, or shortness of breath or if
  you feel anxious or disconnected from your body, thoughts, emotions, space, and time.
• Esketamine may be habit-forming.
• Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription
  medications.
• A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (‘mood elevators’) during clinical studies became suicidal (thinking about harming or
  killing oneself or planning or trying to do so).
• Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal
  than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in
  deciding whether a child or teenager should take an antidepressant.
• Children should not use
  esketamine.
• You should know that your mental health may change in unexpected ways when you use esketamine or
  other antidepressants even if you are an adult over age 24.
• You may become suicidal, especially at the beginning of your treatment and any time that your dose is changed.
• You, your family, or your caregiver
  should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry;
  agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting
  without thinking; severe restlessness; and frenzied abnormal excitement.
• Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
• No matter your age, before you take an antidepressant, you or your caregiver should talk to your doctor
  about the risks and benefits of treating your condition with an antidepressant or with other treatments.
• You should also talk about the risks and benefits of not treating your condition.
• You should know that having depression or another mental illness greatly increases the risk that you will become suicidal.
• This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that
  changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has
  thought about or attempted suicide.
• Talk to your doctor about your condition, symptoms, and personal
  and family medical history.
• You and your doctor will decide what type of treatment is right for you.
• Because of the risks with this medication, esketamine is available only through a special restricted
  distribution program.  A program called Spravato Risk Evaluation and Mitigation Strategies (REMS)
  program. You, your doctor, and your pharmacy must be enrolled in the Spravato REMS program before you can receive this medication.
• You will use esketamine nasal spray in a medical facility under the observation of a doctor or other healthcare professional.
• Keep all appointments with your doctor and the laboratory.
• Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide)
  when you begin treatment with esketamine and each time you refill your prescription.
• Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the
  Food and Drug Administration (FDA) website or the manufacturer’s website to obtain the Medication
  Guide.