Related Experiment Video
Updated: Sep 18, 2025
Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Postmarketing safety analysis of remimazolam: Identifying unlabelled serious events
Weiying Ma1, Rong Zhang, Fan Liu
1From the Department of Anesthesiology, Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University, Shanwei, China (WM, RZ, MC, HH), Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China (WM, RZ, MC, HH), and Department of Pain Medicine, Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University, Shanwei, China (RZ, FL, MC).
Background:
Remimazolam is a new ultra-short-acting benzodiazepine used in anaesthesia, valued for its rapid metabolism and reversibility. Despite its growing clinical use, a comprehensive assessment of its real-world safety profile remains essential.
Objective:
To evaluate the postmarketing safety of remimazolam using adverse event (AE) data from the US and Japanese pharmacovigilance databases.
Design:
Retrospective analysis of AEs associated with remimazolam using disproportionality analysis techniques.
Setting:
FDA Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report database (JADER) from January 2020 to December 2023.
Participants:
Patients who experienced remimazolam-related AEs reported in the FAERS and JADER databases.
Main Outcome Measures:
Identification of significant AEs using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network and multiitem gamma Poisson shrinker. Categorisation of AEs using the 'Important Medical Event Terms List' (IME) list (version 26.1).
Results:
We identified 199 remimazolam-related reports (69 from FAERS, 130 from JADER) revealing 20 significant AEs. Key findings include previously unlabelled serious AEs such as cardiac, cardio-respiratory, and respiratory arrests; nine events classified as Important Medical Events, including hypotension and anaphylaxis; four AEs not included in current Food and Drug Administration (FDA) labelling; and low-frequency but clinically significant off-label events including arrhythmias and postoperative delirium.
Conclusions:
While remimazolam shows a generally acceptable safety profile, our pharmacovigilance analysis identified serious unlabelled reactions requiring clinical vigilance. Practice recommendations include judicious administration with balanced crystalloids and comprehensive cardiorespiratory monitoring. Future research should address prospective surveillance of rare serious events, optimal administration protocols to prevent vascular occlusions and investigation of anaphylactic reactions.
Trial Registration:
Not applicable.
Insights
This study analyzed remimazolam safety data, identifying serious unlabelled adverse events like cardiac arrest and anaphylaxis. Clinical vigilance and monitoring are crucial for this ultra-short-acting anesthetic.
Area of Science:
- Anesthesiology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Remimazolam is a novel ultra-short-acting benzodiazepine for anesthesia.
- Its rapid metabolism and reversibility are key clinical advantages.
- Real-world safety data is crucial given its increasing use.
Purpose of the Study:
- To assess the postmarketing safety of remimazolam.
- Utilized adverse event (AE) data from US and Japanese pharmacovigilance databases.
Main Methods:
- Retrospective analysis of remimazolam-associated AEs.
- Employed disproportionality analysis techniques (e.g., PRR, BNN).
- Data sourced from FDA FAERS and JADER (2020-2023).
Main Results:
- 199 remimazolam-related reports analyzed.
- Identified 20 significant AEs, including unlabelled serious events (cardiac arrest, anaphylaxis).
- Observed AEs like hypotension, arrhythmias, and postoperative delirium.
Conclusions:
- Remimazolam demonstrates an acceptable safety profile overall.
- Identified serious unlabelled reactions necessitate clinical vigilance.
- Recommendations include careful administration and monitoring for adverse events.
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:17Sedatives and Hypnotics Drugs: Miscellaneous Agents
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
01:15REM Sleep Behavior Disorder
RBD is significantly associated with...
01:25Drug Regulation
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
02:07Blind Procedures