About SPRAVATO™

About SPRAVATO™

Get to Know SPRAVATO™

Studied in adults with treatment-resistant depression*

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

Taken with a daily oral antidepressant

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

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

Tell your doctor if you have a history of drug or alcohol abuse

After you take SPRAVATO™, a healthcare professional will monitor you for at least two hours during the observation period for possible side effects. More About Side Effects

*In clinical trials, treatment-resistant depression was defined as adults who are currently struggling with major depressive disorder and who have 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.

SPRAVATO™ Dosing

  • SPRAVATO™ is taken with a daily oral antidepressant
  • You administer SPRAVATO™ nasal spray yourself under the supervision of a healthcare professional 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 doctor to learn more.

SPRAVATO™ Side Effects

Serious side effects include sedation, dissociation, abuse, increased risk of suicidal thoughts and actions, increased blood pressure, problems with thinking clearly and bladder problems. The most commonly observed side effects in adults taking SPRAVATO™ and an oral antidepressant for treatment‑resistant depression were: 

Dissociation (41%)§

Dizziness (29%)

Nausea (28%)

Sedation (23%)

Spinning sensation (23%)

Reduced sense of touch and sensation (18%)

Anxiety (13%) 

Lack of energy (11%)

Increased blood pressure (10%)

Vomiting (9%)

Feeling drunk (5%)

§Dissociation was reported in two ways in the clinical studies: through adverse event reports (41% of patients) and by using a standardized scale (61%–75% of patients).

Sedation was reported in two ways in the clinical studies: through adverse event reports (23% of patients) and by using a standardized scale (49%–61% of patients).

After Treatment

A healthcare professional will monitor you for at least two hours. You won’t be able to drive or operate machinery that requires you 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. SPRAVATO™ is taken with a daily oral antidepressant.

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 doctor to see if you have treatment-resistant depression.  Ask your doctor if SPRAVATO™ may be an option for you.

Of adequate dose and duration.

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. SPRAVATO™ is taken with a daily oral antidepressant.

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. You should let your doctor 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 doctor about methods of birth control that should be used.

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