About SPRAVATO®

About Spravato

About SPRAVATO® For treatment-resistant depression

Get to Know SPRAVATO®

Studied in adults with treatment-resistant depression.*

Nasal spray you self-administer under the supervision of a healthcare provider.

Taken with an oral antidepressant.

Greater reduction of depressive symptoms at four weeks (compared to those who received a placebo and oral antidepressant).

After 16 weeks of therapy, those patients who stayed on SPRAVATO® did better than those who stopped therapy.

Tell your healthcare provider if you have a history of drug or alcohol abuse.

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), feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation), and increased blood pressure. More About Side Effects

*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.

Along with an oral antidepressant.

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.

SPRAVATO® nasal spray

SPRAVATO® Dosing

After you and your healthcare provider have decided SPRAVATO® is right for you – and you understand the benefits and risks of SPRAVATO® – you’ll be ready to start treatment.

  • SPRAVATO® is taken with an oral antidepressant
  • You administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider at a certified SPRAVATO® treatment center
  • SPRAVATO® is taken twice a week for the first four weeks
  • After the first four weeks, SPRAVATO® is taken once a week for a month
  • After this, SPRAVATO® is usually taken either once a week or once every two weeks

SPRAVATO® Safety and Tolerability

  • SPRAVATO® nasal spray was evaluated for safety in both short- and long-term clinical trials of adults diagnosed with treatment-resistant depression
  • Do not take SPRAVATO® if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), a history of bleeding in the brain or are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO®. Talk to your healthcare provider to learn more

SPRAVATO® Side Effects

Serious side effects include feeling sleepy (sedation), dissociation, abuse, increased risk of suicidal thoughts and behavior, increased blood pressure, problems with thinking clearly and bladder problems. The most commonly observed side effects in adults taking SPRAVATO® and an oral antidepressant were:

  • Dissociation

    Feeling disconnected from yourself, your thoughts, feelings and things around you

    X

  • Dizziness
  • Nausea
  • Feeling sleepy (sedation)
  • Spinning sensation
  • Decreased feeling of sensitivity (numbness)
  • Feeling anxious
  • Lack of energy
  • Increased blood pressure
  • Vomiting
  • Feeling drunk
  • Feeling very happy or excited

After Treatment

A healthcare provider will monitor you for at least two hours. Because of possible side effects affecting mental alertness and motor coordination, you won’t be able to drive, operate machinery or do anything where you need to be completely alert until the next day, following a restful sleep. So you’ll need to plan for rides on treatment days.

How Is SPRAVATO® Different?

Today’s most commonly used oral antidepressants are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood.

SPRAVATO® targets the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants. The exact way that SPRAVATO® works is unknown.

Is SPRAVATO® right for you?

If you've struggled with depression and tried two or more antidepressants in your current episode without adequate relief, talk to your healthcare provider to see if you have treatment-resistant depression.

Of adequate dose and duration.

Ask your doctor if SPRAVATO® may be an option for you.

Next:

Preparing for Treatment

The SPRAVATO® treatment plan. 
A different treatment experience.

Frequently Asked Questions

Oral antidepressant medications commonly used today are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood.

SPRAVATO® targets the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants. The exact way that SPRAVATO® works is unknown.

The safety and benefits of SPRAVATO® nasal spray, given with an oral antidepressant, were studied in a clinical program involving short- and long-term trials across more than 1,700 adult patients with treatment-resistant depression that compared SPRAVATO® plus an oral antidepressant to a placebo nasal spray plus an oral antidepressant. These studies evaluated the efficacy and safety of SPRAVATO®, both short-term and long-term for up to one year, for treatment‑resistant depression.

No, treatment with SPRAVATO® is not recommended during pregnancy or while breastfeeding. SPRAVATO® may harm your baby. You should let your healthcare provider know if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. If you are a woman planning to start SPRAVATO®, and are of childbearing age, you should use highly effective contraception while taking SPRAVATO®. Talk with your healthcare provider about methods of birth control that should be used.

If you become pregnant while being treated with SPRAVATO®, you should talk to your healthcare provider as soon as possible about discontinuing treatment and about other options for treating your depression.

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.