SPRAVATO™ demonstrated efficacy in treatment-resistant depression in adults, when administered in conjunction with an oral antidepressant.

SPRAVATO™ demonstrated efficacy in treatment-resistant depression in adults, when administered in conjunction with an oral antidepressant.
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NMDA receptor antagonist approved in conjunction with an oral AD for TRD in adults¹

IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT (AD) FOR TREATMENT-RESISTANT DEPRESSION (TRD) IN ADULTS¹
SPRAVATO™ hypothesized mechanism of action
Studied in more than 1700 adult patients with treatment-resistant depression


References:
1.SPRAVATO™ [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. March 2019.
2.Data on file. Janssen Pharmaceuticals, Inc. Titusville, NJ.
Indication:
SPRAVATO™ (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults.
SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO™ as an anesthetic agent have not been established.
For more information on SPRAVATO treatment, call our mental health clinic at 855.4CHARAK
Spravato is the brand name for esketamine, a prescription nasal spray developed by Janssen (a Johnson & Johnson company). It's derived from ketamine and works on the brain's glutamate system, which is a different mechanism than traditional antidepressants that target serotonin or norepinephrine.
Spravato is FDA-approved for two uses in adults: treatment-resistant depression (TRD), meaning major depressive disorder that hasn't responded adequately to at least two other antidepressants, and major depressive disorder with acute suicidal ideation or behavior. It is not approved as an anesthetic or as a replacement for hospitalization when hospitalization is needed, and its safety and effectiveness have not been established in children.
Yes. Spravato is given alongside an oral antidepressant, not as a standalone treatment.
You self-administer the nasal spray under direct supervision at a certified healthcare facility. Each device delivers two sprays containing a total of 28 mg of esketamine. FDA Depending on your prescribed dose (56 mg or 84 mg), you'll use two or three devices per session with short rest periods between them.
Because of the risk of sedation, dissociation, and changes in blood pressure. Patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. FDA You cannot drive yourself home — you'll need a ride.
Spravato is only available through a restricted program called the SPRAVATO REMS (Risk Evaluation and Mitigation Strategy). It can only be given at certified healthcare settings to patients enrolled in the program. This is due to the risks of sedation, dissociation, and potential for misuse as a Schedule III controlled substance.
For treatment-resistant depression, the typical protocol is an induction phase of twice-weekly sessions for the first 4 weeks, then once-weekly sessions for weeks 5–8, followed by a maintenance phase of sessions every 1–2 weeks based on response. Your provider will tailor this to you.
Many patients notice some improvement within the first week or two, which is much faster than traditional oral antidepressants that often take 4–8 weeks. Response varies significantly from person to person.
The most frequently reported side effects include dissociation (a feeling of being detached from your body or surroundings), dizziness, nausea, sedation, vertigo, a spinning sensation, decreased sensitivity, anxiety, increased blood pressure, vomiting, and feeling drunk. Most of these occur during or shortly after dosing and typically resolve within the 2-hour monitoring window.
People with certain vascular conditions or an allergy to esketamine or ketamine should not use it. Contraindications include aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation FDA, a history of intracerebral hemorrhage, and hypersensitivity to esketamine, ketamine, or any excipients. Tell your provider about any history of high blood pressure, heart disease, liver problems, substance use, or psychotic symptoms.
No. Spravato is not recommended during pregnancy, and breastfeeding is not recommended during treatment because esketamine passes into breast milk. There is a pregnancy registry for patients who become pregnant during treatment.
You'll typically be asked to avoid food for at least 2 hours and liquids for at least 30 minutes before treatment to reduce the risk of nausea and vomiting. You'll also need to avoid using nasal decongestants within an hour of your dose since they can affect absorption.
Spravato is a Schedule III controlled substance, which means it has some potential for abuse and dependence. This is part of why it's only administered in supervised settings. Your provider will monitor you for signs of misuse throughout treatment.
Without insurance, Spravato runs roughly $700–$1,200 per dose for the medication itself, plus facility and monitoring fees. With commercial insurance, most patients pay between $10 and $125 per session after meeting their deductible. Medicare typically covers 80% under Part B. Janssen's "Spravato withMe" copay assistance program can reduce out-of-pocket costs to as little as $10 per session for eligible commercially insured patients, with an annual cap. The program does not apply to Medicare or Medicaid enrollees.
Most major insurers — including Aetna, Anthem/BCBS, Cigna, UnitedHealthcare, Medicare, and most state Medicaid plans — cover Spravato for approved indications, but prior authorization is almost always required. Insurers typically want documentation that you've tried and not adequately responded to at least two oral antidepressants.