SPRAVATO®
(esketamine)
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SPRAVATO® (esketamine)
Medical Information
Dosing of SPRAVATO - Tapering Upon Discontinuation
Last Updated: 02/20/2025
SUMMARY
- SPRAVATO nasal spray contains 28 mg of esketamine per device. The recommended maintenance dosing for treatment-resistant depression (TRD) is 56 mg or 84 mg every 2 weeks or weekly based on efficacy and tolerability.1
In accordance with good clinical practice, a decision to discontinue treatment with SPRAVATO should be determined based on clinical judgment and careful patient monitoring for worsening of mood. - In clinical trials with SPRAVATO for TRD, patients did not taper the SPRAVATO dose nor decrease the dosing frequency for the purposes of treatment discontinuation.
- There was no evidence of withdrawal symptoms observed up to 4 weeks after cessation of SPRAVATO treatment in the phase 3 clinical trial program in TRD.2
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Literature Search
References
| 1 | Center for Drug Evaluation and Research. Clinical pharmacology and biopharmaceutics review. NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019- [cited 2025 January 21]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000ClinPharmR.pdf |
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