J&J Medical Connect
SPRAVATO®

(esketamine)

This information is intended for US patients and caregivers to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended to promote the use of our products, nor to provide medical advice.

SPRAVATO® (esketamine)

Patient Medical Information

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What is the difference between SPRAVATO Nasal Spray and Ketamine?

Last Updated: 01/24/2025

summary

  • Both SPRAVATO and ketamine are controlled substances (CIII) and have a risk for abuse and physical and psychological dependence.1,2
  • SPRAVATO is approved by the Food and Drug Administration (FDA) as a prescription medicine to treat3:
    • Adults with treatment-resistant depression (TRD) with or without an antidepressant taken by mouth.
    • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions along with an antidepressant taken by mouth.
  • It is not known if SPRAVATO is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO.3
  • It is not known if SPRAVATO is safe and effective in children.3
  • SPRAVATO is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO is safe and effective as an anesthetic medicine.3
  • Ketamine is not a FDA-approved prescription medicine for treatment of depression-related conditions in any form.1
    • In order for a medicine to be FDA-approved, manufacturers must meet rigorous standards to show that the medicine is both safe and effective for a particular disease or condition.4
  • Because of the risks for sedation, dissociation, respiratory depression, and abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program. 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.3

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest use in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for SPRAVATO.3

References

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1 U.S. Food and Drug Administration | Center for Drug Evaluation and Research. Accessed July 16th, 2024. https://www.accessdata.fda.gov/scripts/cder/daf/
2 Drug Enforcement Administration Diversion Control Division. Accessed July 16th, 2024. https://www.dea.gov/drug-information/drug-scheduling
3 SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf
4 U.S. Food and Drug Administration | FDA Drug Review. Accessed July 16th, 2024. https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review