Byfavo (Remimazolam): Uses, Dosage & Side Effects
An ultra-short-acting benzodiazepine sedative for procedural sedation in adults, administered intravenously by trained healthcare professionals
Byfavo (remimazolam) is an ultra-short-acting benzodiazepine sedative approved for procedural sedation in adults. Administered intravenously, it acts rapidly within 1–3 minutes and wears off predictably due to its unique metabolism by tissue esterases rather than liver enzymes. This gives Byfavo a favorable pharmacokinetic profile with faster recovery times compared to traditional benzodiazepines such as midazolam. Byfavo must only be administered by healthcare professionals experienced in sedation, with continuous monitoring of breathing, heart rate, and blood pressure. Its effects can be reversed with flumazenil if necessary.
Quick Facts: Byfavo
Key Takeaways
- Byfavo (remimazolam) is an ultra-short-acting benzodiazepine used exclusively for procedural sedation in adults, administered intravenously in controlled clinical settings by trained healthcare professionals.
- Unlike traditional benzodiazepines, remimazolam is metabolized by tissue esterases (not liver CYP450 enzymes), resulting in predictable, rapid recovery regardless of age, liver function, or body weight.
- Clinical trials demonstrate significantly faster recovery times compared to midazolam, with most patients achieving full alertness within 10–20 minutes of the last dose.
- The most common side effects are low blood pressure (hypotension) and respiratory depression; continuous monitoring of vital signs is mandatory throughout the procedure.
- The effects of Byfavo can be reversed with flumazenil (a benzodiazepine antagonist), which must always be immediately available during administration.
What Is Byfavo and What Is It Used For?
Byfavo contains the active substance remimazolam, which belongs to the benzodiazepine class of medications. Benzodiazepines work by enhancing the activity of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system. By binding to a specific site on the GABA-A receptor complex, remimazolam increases the frequency of chloride ion channel opening, leading to neuronal hyperpolarization and a dose-dependent reduction in central nervous system activity. This produces the characteristic effects of sedation, anxiolysis (anxiety reduction), and anterograde amnesia (inability to form new memories during the period of drug effect).
What sets remimazolam apart from other benzodiazepines is its unique chemical structure, which incorporates an ester bond. This ester bond is rapidly hydrolyzed by ubiquitous tissue esterases (carboxylesterase 1, or CES-1) to form an inactive carboxylic acid metabolite known as CNS 7054. Because this metabolic pathway is independent of the cytochrome P450 (CYP450) hepatic enzyme system, remimazolam exhibits what pharmacologists call a “context-insensitive half-time” — meaning its duration of action does not significantly increase with longer infusion times or repeated doses. This property makes it highly predictable in clinical practice.
Byfavo is specifically indicated for procedural sedation in adults. This encompasses a wide range of diagnostic and therapeutic procedures, including but not limited to upper gastrointestinal endoscopy (gastroscopy), colonoscopy, bronchoscopy, cardiac catheterization, minor surgical procedures requiring sedation, dental procedures, radiological interventions, and other diagnostic procedures requiring patient cooperation in a sedated state. The goal of procedural sedation is to reduce patient anxiety and discomfort while maintaining an adequate level of consciousness to allow cooperation and preserve protective reflexes.
Byfavo was approved by the European Medicines Agency (EMA) in 2021 and has also received regulatory approval in the United States (FDA, 2020) and Japan (PMDA, 2020) for procedural sedation. It was developed as a next-generation sedative designed to offer the reliability and reversibility of benzodiazepine sedation while addressing the limitations of older agents such as midazolam, particularly with respect to prolonged and unpredictable recovery times. Clinical trials, including the pivotal Phase III studies published in peer-reviewed journals, have consistently demonstrated that remimazolam provides effective sedation with faster onset and recovery compared to midazolam, as well as a lower incidence of injection-site reactions compared to propofol.
The medication is supplied as a white to off-white powder in single-use vials, each containing remimazolam besylate equivalent to 20 mg of remimazolam. Before administration, the powder must be reconstituted with 8.2 ml of 0.9% sodium chloride (normal saline) to yield a final concentration of 2.5 mg/ml. The reconstituted solution should be clear and colorless to pale yellow in appearance. Byfavo is administered exclusively by intravenous injection; it is not suitable for oral, intramuscular, or any other route of administration.
What Should You Know Before Receiving Byfavo?
Contraindications
There are specific clinical situations in which Byfavo must not be administered. Understanding these absolute contraindications is essential for patient safety. Byfavo is contraindicated in the following circumstances:
- Known hypersensitivity: You must not receive Byfavo if you have a known allergy to remimazolam, any other benzodiazepine (such as midazolam, diazepam, or lorazepam), or any of the excipients in the formulation including dextran 40 for injection, lactose monohydrate, hydrochloric acid, or sodium hydroxide.
- Unstable myasthenia gravis: Byfavo is contraindicated in patients with an unstable form of myasthenia gravis, particularly when the disease affects the respiratory muscles (chest muscles that help with breathing). Benzodiazepines can further depress respiratory muscle function, creating a potentially life-threatening situation in these patients.
Warnings and Precautions
Byfavo must only be administered by healthcare professionals experienced in sedation. Continuous monitoring of respiratory function, cardiac rhythm, and blood pressure is mandatory. Resuscitation equipment, airway management devices, and flumazenil (a benzodiazepine antagonist) must be immediately available.
Before receiving Byfavo, you should inform your doctor or nurse about any serious medical conditions. This is particularly important because certain pre-existing conditions may affect how your body responds to the sedation and may require dose adjustments or enhanced monitoring. The following conditions require special attention:
- Very low or very high blood pressure, or tendency to faint: Byfavo can lower blood pressure, which may be more pronounced in patients with pre-existing hemodynamic instability. Your doctor will adjust the dose accordingly and monitor your blood pressure closely.
- Heart problems, especially very slow and/or irregular heartbeat (arrhythmia): Benzodiazepines can occasionally affect cardiac conduction. Patients with significant cardiac disease, particularly bradyarrhythmias or heart block, require continuous cardiac monitoring during sedation with Byfavo.
- Breathing problems such as shortness of breath: Byfavo, like all benzodiazepines, can cause respiratory depression. Patients with pre-existing respiratory conditions including chronic obstructive pulmonary disease (COPD), sleep apnea, or restrictive lung disease may be more susceptible to respiratory depression and require lower doses and closer monitoring of oxygen saturation.
- Severe liver problems: While remimazolam is primarily metabolized by tissue esterases rather than hepatic CYP450 enzymes, patients with severe hepatic impairment may show increased sensitivity to the sedative effects. Dose reduction and prolonged observation may be necessary.
- Myasthenia gravis (stable form): Even in stable myasthenia gravis, careful monitoring of respiratory function is essential, as benzodiazepines may exacerbate muscle weakness.
- History of drug or alcohol misuse: Patients with a history of substance abuse or dependence may have altered sensitivity to benzodiazepines. The risk of psychological dependence is minimal with single-dose procedural sedation use, but clinical vigilance is appropriate.
Byfavo can cause anterograde amnesia (inability to form new memories) during and for a variable period after its administration. This is a normal pharmacological effect of benzodiazepines. Your doctor will assess your recovery before discharge and will provide post-procedure instructions, which should ideally be given in writing as well as verbally, and preferably also communicated to a responsible companion.
Children and Adolescents
Byfavo should not be administered to patients under 18 years of age. The safety and efficacy of remimazolam have not been established in the pediatric population. Clinical trials for procedural sedation were conducted exclusively in adult patients. Until pediatric-specific studies are completed and regulatory approvals are obtained, alternative sedation agents with established pediatric safety profiles should be used for patients under 18.
Pregnancy and Breastfeeding
Byfavo should not be used during pregnancy unless clearly necessary and the potential benefit justifies the potential risk to the fetus. Animal studies with benzodiazepines have shown potential reproductive toxicity, and there are insufficient data on the use of remimazolam in pregnant women. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, inform your doctor immediately before the procedure. Your doctor will consider alternative sedation approaches or weigh the absolute necessity of the procedure.
If you are breastfeeding, you should not breastfeed for 24 hours after receiving Byfavo. Although the rapid metabolism of remimazolam suggests that drug levels in breast milk are likely to decline quickly, a 24-hour interruption of breastfeeding is recommended as a precautionary measure to avoid any potential exposure of the infant. Breast milk expressed during this 24-hour period should be discarded.
Driving and Operating Machinery
Byfavo causes drowsiness, impaired memory, and reduced concentration. Although these effects typically resolve relatively quickly due to the short duration of action of remimazolam, you must not drive, operate machinery, or perform other activities requiring alertness and coordination until these effects have completely resolved. Your doctor will advise you on when it is safe to resume these activities. As a general rule, patients should arrange for someone else to drive them home after a procedure involving sedation and should not plan to make important decisions or sign legal documents for the remainder of the day.
Important Information About Some of the Ingredients
Byfavo contains 79.13 mg of dextran 40 for injection per vial. Dextrans can, in rare cases, cause severe allergic reactions (anaphylactoid reactions). If you experience difficulty breathing, swelling, or feel faint and light-headed during or after administration, seek immediate medical assistance. Healthcare professionals administering Byfavo should be prepared to manage anaphylactoid reactions to dextran.
How Does Byfavo Interact with Other Drugs?
Drug interactions with Byfavo are primarily pharmacodynamic rather than pharmacokinetic. Because remimazolam is metabolized by tissue esterases (CES-1) rather than by hepatic CYP450 enzymes, it has a relatively low potential for metabolic drug interactions. However, its central nervous system depressant effects can be additive or synergistic when combined with other CNS depressant agents, and this represents the most clinically significant category of interactions.
Always inform your healthcare team about all medications you are currently taking, have recently taken, or might take, including over-the-counter medicines, herbal remedies, and dietary supplements. This is crucial for safe sedation planning.
Major Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Opioids (morphine, fentanyl, codeine, tramadol) | Significantly enhanced sedation, respiratory depression, and hypotension. Concurrent use of opioids and benzodiazepines carries the highest risk of serious respiratory compromise. | If opioids are used concurrently for procedural analgesia, reduced doses of both agents are recommended. Enhanced respiratory monitoring is mandatory. This combination should only be used by experienced practitioners. |
| Other benzodiazepines (midazolam, diazepam, lorazepam) | Additive CNS depression with increased depth and duration of sedation. Increased risk of over-sedation, respiratory depression, and prolonged recovery. | Avoid concurrent use. If the patient has taken a benzodiazepine prior to the procedure, the dose of Byfavo should be significantly reduced. |
| Antipsychotics (haloperidol, quetiapine, olanzapine) | Enhanced sedation and increased risk of hypotension, respiratory depression, and excessive CNS depression. | Use lower initial doses of Byfavo. Monitor blood pressure and respiratory function closely. Consider the patient's chronic antipsychotic regimen when planning sedation. |
| Sedative antihistamines (promethazine, hydroxyzine, diphenhydramine) | Additive sedation and CNS depression, with potential for prolonged drowsiness and impaired recovery. | Consider timing of antihistamine use relative to the procedure. Lower doses of Byfavo may be appropriate. |
Minor Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Antidepressants (SSRIs, SNRIs, TCAs) | Mild additive CNS depression. Tricyclic antidepressants may have a more pronounced interaction due to their inherent sedative properties. | Inform the proceduralist about your antidepressant medication. Dose adjustment of Byfavo may be considered based on individual response. |
| Antihypertensives (beta-blockers, calcium channel blockers, ACE inhibitors) | May potentiate the hypotensive effect of Byfavo, increasing the risk of significant blood pressure drops during the procedure. | Continue antihypertensive medications as prescribed unless your doctor advises otherwise. Close blood pressure monitoring during and after the procedure. |
| Anxiolytics (buspirone, pregabalin, gabapentin) | Mild to moderate additive sedation, particularly with pregabalin and gabapentin which have inherent sedative effects. | Inform your proceduralist. May require reduced doses of Byfavo for adequate sedation. |
Alcohol Interaction
Alcohol is a central nervous system depressant that can significantly potentiate the sedative, respiratory depressant, and hemodynamic effects of Byfavo. You should inform your healthcare team about your alcohol consumption habits and any history of alcohol use disorder. You must not consume alcohol for at least 24 hours before receiving Byfavo, as residual alcohol effects could alter your response to sedation in unpredictable and potentially dangerous ways.
What Is the Correct Dosage of Byfavo?
Byfavo is always administered by a healthcare professional — you will never need to calculate or self-administer the dose. Your doctor will determine the appropriate dose based on your clinical response, the type and duration of the procedure, your age, body weight, and overall health status. The dose is titrated to the desired level of sedation, with the goal of achieving adequate sedation while minimizing the risk of over-sedation and respiratory depression.
During the procedure, your breathing, heart rate, blood pressure, and oxygen levels are continuously monitored, and the doctor adjusts the dose as needed. After the procedure, you will remain under observation until you have recovered sufficiently to be safely discharged.
Adults (18–64 years)
Standard Adult Dosing
Initial dose: 5 mg (2 ml of the reconstituted 2.5 mg/ml solution) administered as a slow intravenous injection over approximately 1 minute. Sedation onset typically occurs within 1–3 minutes.
Supplemental doses: If additional sedation is needed, supplemental doses of 2.5 mg (1 ml) may be administered at intervals of at least 2 minutes. The dose is titrated based on clinical assessment of the patient's level of sedation.
Maximum dose: Doses should be individualized and titrated to clinical effect. There is no fixed maximum total dose, but the cumulative dose should be guided by the patient's response and the expected duration of the procedure.
Elderly Patients (65 years and over)
Elderly Patient Dosing
Initial dose: A reduced initial dose of 2.5–5 mg may be appropriate, administered slowly. Elderly patients are generally more sensitive to the effects of benzodiazepines due to age-related changes in pharmacodynamics and may require lower total doses.
Supplemental doses: Supplemental doses of 1.25–2.5 mg may be given at intervals of at least 2 minutes, titrated carefully to clinical effect.
Monitoring: Enhanced monitoring is recommended, as elderly patients may have increased risk of hypotension, bradycardia, and respiratory depression. Recovery time may be slightly prolonged compared to younger adults.
Children and Adolescents (under 18 years)
Pediatric Dosing
Not recommended. Byfavo has not been studied in patients under 18 years of age. The safety, efficacy, and appropriate dosing in the pediatric population have not been established. Alternative sedation agents with established pediatric safety profiles should be used for patients in this age group.
Special Populations
Hepatic impairment: For patients with mild to moderate hepatic impairment, no dose adjustment is generally required because remimazolam is primarily metabolized by tissue esterases rather than hepatic enzymes. However, patients with severe hepatic impairment may exhibit increased sensitivity to the sedative effects and should receive lower initial doses with careful titration. Pharmacokinetic studies have shown that while the clearance of remimazolam itself is not significantly affected by hepatic impairment, the clearance of the inactive metabolite (CNS 7054) may be reduced.
Renal impairment: No dose adjustment is required for patients with renal impairment. Remimazolam and its metabolites are primarily eliminated by renal excretion, but accumulation of the pharmacologically inactive metabolite CNS 7054 is not expected to cause clinically significant effects during the typical duration of procedural sedation.
Overdose
Overdose with Byfavo may manifest as excessive sedation, confusion, drowsiness, blurred vision or involuntary eye movements, agitation, muscle weakness, hypotension (low blood pressure), bradycardia (slow heart rate), respiratory depression (slow, shallow breathing), and in severe cases, loss of consciousness.
In the event of an overdose, the healthcare team will manage the situation using established protocols. The primary treatment approach includes:
- Airway management: Ensuring a patent airway and providing supplemental oxygen or assisted ventilation as needed.
- Cardiovascular support: Monitoring and treating hypotension with intravenous fluids and vasopressors if necessary, and managing bradycardia as clinically indicated.
- Flumazenil administration: Flumazenil is a specific benzodiazepine antagonist that can reverse the sedative effects of remimazolam. It competitively blocks the benzodiazepine binding site on the GABA-A receptor. Flumazenil should be administered in titrated doses according to the patient's response. It is important to note that flumazenil has a shorter duration of action than some benzodiazepines, so re-sedation may occur and repeated doses or continuous observation may be necessary.
- Supportive care: Continuous monitoring of vital signs until the patient has fully recovered. Due to the rapid metabolism of remimazolam by tissue esterases, recovery from overdose is expected to be faster than with longer-acting benzodiazepines.
What Are the Side Effects of Byfavo?
Like all medicines, Byfavo can cause side effects, although not everyone will experience them. The side effects described below are based on data from clinical trials and post-marketing surveillance. Most side effects associated with Byfavo are transient and directly related to its pharmacological action as a CNS depressant. The rapid metabolism of remimazolam means that most side effects resolve more quickly than with longer-acting benzodiazepines.
It is important to understand that procedural sedation carries inherent risks regardless of the specific agent used. Your healthcare team is trained to recognize and manage these effects promptly. The benefits of adequate sedation for your procedure have been weighed against these risks.
Very Common
May affect more than 1 in 10 patients
- Hypotension (low blood pressure): The most frequently reported side effect. Usually transient and managed with intravenous fluids. More pronounced when Byfavo is used with opioids. Patients with pre-existing hypotension or hypovolemia are at higher risk.
- Respiratory depression and hypoxaemia: Unusually slow or shallow breathing with resultant low blood oxygen levels. Managed with supplemental oxygen, airway positioning, or assisted ventilation as needed. This risk is increased when opioids are co-administered.
Common
May affect up to 1 in 10 patients
- Headache: Usually mild and self-limiting, resolving within hours of the procedure.
- Dizziness: Typically occurs during the recovery phase and resolves as the drug is metabolized.
- Bradycardia (slow heart rate): May occur particularly in patients already taking heart rate-lowering medications such as beta-blockers.
- Nausea: Common after procedural sedation and may be related to the procedure itself as well as the sedative agent.
- Vomiting: Less frequent than nausea and usually self-limiting.
Uncommon
May affect up to 1 in 100 patients
- Somnolence (excessive drowsiness): Prolonged drowsiness beyond the expected recovery period.
- Feeling cold: A sensation of coldness, possibly related to peripheral vasodilation.
- Chills (rigors): Shivering episodes during recovery.
- Hiccups (singultus): Involuntary diaphragmatic contractions that are usually self-limiting.
Not Known
Frequency cannot be estimated from available data
- Severe allergic reaction (anaphylaxis): Sudden, potentially life-threatening allergic reaction. This may be related to the dextran 40 excipient rather than remimazolam itself. Symptoms include difficulty breathing, facial or throat swelling, rapid heartbeat, severe hypotension, and skin rash or urticaria. Requires immediate emergency treatment.
If you experience any side effects after receiving Byfavo, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed above. You can also report side effects directly to your national medicines regulatory authority (e.g., MHRA in the UK, FDA MedWatch in the US, EMA in Europe). By reporting side effects, you help provide more information on the safety of this medicine.
How Should Byfavo Be Stored?
As a hospital-administered medication, you will not need to store Byfavo yourself. The hospital or clinic pharmacy staff are responsible for proper storage and handling. However, for completeness, the following storage conditions apply:
- Unopened vials: Store in the original outer carton to protect from light. No special temperature storage requirements beyond standard room temperature conditions. Keep out of sight and reach of children.
- After reconstitution: The reconstituted solution has demonstrated chemical and physical stability for 24 hours at 20–25°C. However, from a microbiological standpoint, unless the method of reconstitution precludes the risk of microbial contamination, the solution should be used immediately after preparation.
- Do not use: After the expiry date stated on the carton and vial. Do not use if the reconstituted solution shows visible particles or discoloration.
- Single-use only: Byfavo is supplied in single-use vials. Any unused reconstituted solution must be discarded in accordance with local institutional requirements.
What Does Byfavo Contain?
Active Ingredient
The active substance in Byfavo is remimazolam, present as remimazolam besylate. Each single-use vial contains remimazolam besylate equivalent to 20 mg of remimazolam base. After reconstitution with 8.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, each milliliter of the reconstituted solution contains 2.5 mg of remimazolam. Remimazolam is chemically described as methyl 3-[(4S)-8-bromo-1-methyl-6-(pyridin-2-yl)-4H-imidazo[1,2-a][1,4]benzodiazepine-4-yl]propanoate, and its molecular formula is C21H19BrN4O2.
Inactive Ingredients (Excipients)
- Dextran 40 for injection: A branched polysaccharide used as a bulking agent and to improve the physical properties of the lyophilized powder. Note: Dextrans can rarely cause severe allergic reactions (see Warnings section).
- Lactose monohydrate: A sugar used as a bulking agent in the lyophilized powder formulation. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should inform their doctor, although the small amount present is unlikely to cause symptoms.
- Hydrochloric acid: Used for pH adjustment during manufacturing.
- Sodium hydroxide: Used for pH adjustment during manufacturing.
Physical Description
Byfavo is supplied as a white to off-white powder (lyophilisate) for solution for injection, packaged in glass vials with a rubber stopper and aluminium seal. Each carton contains 10 vials. After reconstitution with 0.9% sodium chloride, the solution should appear clear and colorless to pale yellow. Do not use if the solution appears cloudy, discolored, or contains visible particles.
Compatibility and Incompatibility
Reconstituted Byfavo is compatible with the following intravenous solutions when administered through the same intravenous line:
- Glucose 5% (50 mg/ml) solution for injection
- Glucose 20% (200 mg/ml) solution for injection
- Glucose 5% – Sodium chloride 0.45% solution for injection
- Ringer’s solution
- Sodium chloride 0.9% (9 mg/ml) solution for injection
Byfavo is incompatible with Ringer-lactate (also known as sodium lactate solution or Hartmann’s solution), Ringer-acetate, and Ringer-bicarbonate infusion solutions. These must not be used to reconstitute or co-administer with Byfavo. After reconstitution, do not mix with other medicinal products except those listed above.
Frequently Asked Questions About Byfavo
Byfavo (remimazolam) is used for procedural sedation in adults. It is an intravenous sedative given before and during medical procedures such as endoscopies, colonoscopies, bronchoscopies, and minor surgical interventions to make patients relaxed, calm, and sleepy. It is only administered in clinical settings by healthcare professionals experienced in sedation, with continuous monitoring of vital signs.
Byfavo (remimazolam) offers several advantages over midazolam and propofol. Compared to midazolam, remimazolam provides faster and more predictable recovery due to its metabolism by tissue esterases rather than liver CYP450 enzymes. Unlike propofol, remimazolam has a specific reversal agent (flumazenil), provides an additional safety margin in case of over-sedation, and causes fewer injection-site reactions. Clinical trials have shown that Byfavo provides comparable sedation efficacy to these established agents with an improved pharmacokinetic profile.
Yes, although rare, allergic reactions can occur with Byfavo. These may be caused by the active substance (remimazolam) or by one of the excipients, particularly dextran 40. In rare cases, dextrans can cause severe anaphylactoid reactions with symptoms such as difficulty breathing, swelling, and feeling faint. If you have a known allergy to any benzodiazepine or to dextran, you must inform your doctor before the procedure. Emergency medications and resuscitation equipment are always available wherever Byfavo is administered.
After the procedure, you will be monitored in a recovery area until your healthcare team determines that you have recovered sufficiently to be safely discharged. Due to the short duration of action of remimazolam, recovery is typically faster than with traditional benzodiazepines. Most patients recover full alertness within 10–20 minutes after the last dose. However, the exact monitoring period depends on your individual response, the amount of sedation received, and whether other medications (such as opioids) were co-administered. Your doctor will assess your level of alertness, orientation, and vital signs before discharge.
One of the advantages of Byfavo (remimazolam) compared to many other sedatives is that its metabolism is primarily performed by tissue esterases (carboxylesterase 1) rather than liver-based CYP450 enzymes. This means that mild to moderate liver impairment generally does not significantly affect how the drug is broken down. However, patients with severe liver problems may be more sensitive to the sedative effects and may require lower doses with more careful monitoring. Your doctor will assess your liver function and adjust the approach accordingly.
Byfavo, like other benzodiazepines, can cause anterograde amnesia — meaning you may not remember events that occurred during the period of sedation. This is actually a desirable effect for procedural sedation, as it means patients typically do not recall the discomfort of the procedure. The degree of amnesia varies between individuals and depends on the dose administered. Your doctor will provide post-procedure instructions both verbally and in writing, and it is recommended that you have a responsible companion present to receive these instructions as well.
References
- European Medicines Agency (EMA). Byfavo (remimazolam) – Summary of Product Characteristics. Updated 2023. Available at: EMA EPAR: Byfavo.
- U.S. Food and Drug Administration (FDA). Byfavo (remimazolam) for injection – Prescribing Information. Revised 2024. Available at: FDA Label: Byfavo.
- Rex DK, Bhandari R, Engel AJ, et al. Safety and efficacy of remimazolam compared to placebo and midazolam for moderate sedation during bronchoscopy. J Clin Anesth. 2021;68:110085. doi: 10.1016/j.jclinane.2020.110085.
- Borkett KM, Riff DS, Schwartz HI, et al. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015;120(4):771–780. doi: 10.1213/ANE.0000000000000548.
- Worthington MT, Antonik LJ, Engel AJ, et al. Remimazolam versus midazolam for moderate procedural sedation: a randomized controlled trial in colonoscopy patients. Gastrointest Endosc. 2022;96(1):39–50.
- Kilpatrick GJ. Remimazolam: non-clinical and clinical profile of a novel sedative for procedural sedation. Front Pharmacol. 2021;12:690875. doi: 10.3389/fphar.2021.690875.
- Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020;33(4):506–511. doi: 10.1097/ACO.0000000000000877.
- European Society of Anaesthesiology and Intensive Care (ESAIC). Practice guidelines for procedural sedation and analgesia. Eur J Anaesthesiol. 2023;40(2):81–112.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
About This Article
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians with specializations in anaesthesiology, clinical pharmacology, and internal medicine. All medical information is based on current international guidelines, the approved Summary of Product Characteristics (SmPC) from the European Medicines Agency, FDA-approved prescribing information, and peer-reviewed clinical studies.
Our editorial process follows the GRADE evidence framework to ensure the highest quality of medical information. All content undergoes:
- Initial drafting by medical writers with clinical pharmacy or medical qualifications
- Medical accuracy review by a board-certified physician specialist
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