Active Ingredient: REMIMAZOLAM
Remimazolam cardiac repolarization assessment exhibits regulatory nuance between clinical bolus dynamics and steady-state data. In the FDA QT-IRT evaluation of the thorough QT trial (CNS7056-005), remimazolam produced marked heart rate increases (+12.3 to +15.2 bpm) with transient QTc increases exceeding the 10 ms regulatory threshold within the first 2 minutes post-bolus, similarly observed with midazolam. In a continuous infusion trial (CNS7056-017) minimizing hysteresis, maximum baseline change was 3.7 ms (upper 90% CI 8.5 ms). The FDA QT-IRT recommended product labeling to reflect heart rate elevation and transient QTc prolongation.
https://doi.org/10.1111/bcp.14270, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212295Orig1s000ClinPharmR.pdf