Remimazolam: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 13, 2026🚩 Report this page

Remimazolam

Benzodiazepine Derivatives

Sold as BYFAVO

GB MHRAEU EMA

Drug class: Benzodiazepine Derivatives
Availability: See label
Markets covered: 2
Products on record: 5

Overview

Remimazolam is an active pharmaceutical ingredient in the Benzodiazepine Derivatives group (N05CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	March 13, 2026
EU European Union	EMA	1	November 28, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised March 13, 2026[1]

Remimazolam is indicated in adults for procedural sedation.

How to take

GBOfficial regulatory label

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised November 28, 2025[2]

Remimazolam is indicated in adults for procedural sedation.

How to take

EUOfficial regulatory label

Drug interactions

Known interactions involving Remimazolam. Select one for details. This list is informational and not a complete interaction checker.

Alfentanil Benzhydrocodone Buprenorphine Butorphanol Clozapine Codeine Dezocine Dihydrocodeine Droperidol Fentanyl Fospropofol Hydrocodone Hydromorphone Levorphanol Meperidine Methadone Morphine Nalbuphine Olanzapine Oliceridine Oxycodone Oxymorphone Pentazocine Propofol Propoxyphene Remifentanil Sufentanil Tapentadol Tramadol Acetazolamide Aldesleukin Alfuzosin Amiloride Amitriptyline Amobarbital Amoxapine Apomorphine Apraclonidine Aripiprazole Articaine Asenapine Atenolol Atracurium Azatadine Azelastine Azilsartan Baclofen Bendroflumethiazide Benzthiazide Bepridil Betaxolol Biperiden Bisoprolol Brexanolone Brexpiprazole Brimonidine Brivaracetam Bromocriptine Brompheniramine Bumetanide Bupivacaine Bupropion Cannabidiol Captopril Carbinoxamine Cariprazine Carisoprodol Carteolol Carvedilol Cenobamate Cetirizine Chlordiazepoxide Chloroprocaine Chlorothiazide Chlorphenesin Chlorpheniramine Chlorthalidone Chlorzoxazone Cisatracurium Citalopram Clemastine Clevidipine Clobazam Clomipramine Clonidine Clorazepate Cyclobenzaprine Cyproheptadine Dantrolene Deserpidine Desipramine Desvenlafaxine Deutetrabenazine Dexbrompheniramine Dexmedetomidine Dextromethorphan Diazoxide Digoxin Diphenhydramine Disulfiram Doxacurium Doxazosin Doxepin Doxylamine Dronabinol Duloxetine Enalapril Entacapone Eplerenone Eprosartan Escitalopram Esketamine Eslicarbazepine Esmolol Estazolam Eszopiclone Ethacrynate Ethanol Ethchlorvynol Ethotoin Etidocaine Ezogabine Fenoldopam Flavoxate Flibanserin Fluoxetine Fluphenazine Flurazepam Fosinopril Fosphenytoin Furosemide Guanabenz Guanadrel Guanethidine Guanfacine Halazepam Haloperidol Hydralazine Hydrochlorothiazide Hydroflumethiazide Ifosfamide Iloperidone Imipramine Indapamide Irbesartan Isocarboxazid Isosorbide Dinitrate Ketamine Lasmiditan Lemborexant Levamlodipine Levobupivacaine Levocetirizine Levodopa Lidocaine Lisinopril Lofexidine Losartan Lumateperone Lurasidone Maprotiline Meclizine Mephenytoin Mepivacaine Mesoridazine Metaxalone Methazolamide Methdilazine Methocarbamol Metoclopramide Metocurine Metolazone Metyrosine Minoxidil Mirtazapine Mivacurium Moexipril Molindone Nabilone Nadolol Nebivolol Nimodipine Nitroglycerin Nitroprusside Nortriptyline Olmesartan Olopatadine Opicapone Opium Orphenadrine Paliperidone Pancuronium Paraldehyde Paroxetine Penbutolol Pentobarbital Perampanel Pergolide Perindopril Perphenazine Phenelzine Phenindamine Phenobarbital Phenoxybenzamine Phentolamine Phenyltoloxamine Phenytoin Pimozide Pindolol Pipecuronium Polythiazide Pramipexole Prazosin Pregabalin Prilocaine Primidone Procaine Prochlorperazine Procyclidine Promazine Promethazine Propiomazine Protriptyline Pyrilamine Quazepam Quetiapine Quinapril Ramelteon Ramipril Rapacuronium Rasagiline Reserpine Risperidone Rocuronium Ropinirole Ropivacaine Rotigotine Rufinamide Secobarbital Sibutramine

Showing 240 of 301. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB597680001 · revised March 13, 2026
[2]European Medicines Agency · EMEA/H/C/005246 · revised November 28, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Remimazolam must only be administered by healthcare professionals experienced in sedation. The patient should be monitored throughout by a separate healthcare professional, who is not involved in the conduct of the procedure, and whose sole task is to monitor the patient.
This personnel must be trained in the detection and management of airway obstruction, hypoventilation and apnoea, including the maintenance of a patent airway, supportive ventilation and cardiovascular resuscitation. The patient´s respiratory and cardiac function must be continuously monitored.
Resuscitative medicinal products and age- and size-appropriate equipment for restoring airway patency and bag/valve/mask ventilation must be immediately available. A benzodiazepine reversal medicinal product (flumazenil) must be immediately available for use.
Posology Remimazolam dosing should be individually titrated to an effective dose which provides the desired level of sedation and minimises adverse reactions (see Table 1). Additional doses can be administered as needed to induce or maintain the desired level of sedation.
At least 2 minutes should elapse prior to administration of any supplemental dose in order to fully assess the sedative effect. If 5 doses of remimazolam within 15 minutes do not result in the desired level of sedation then an additional or another sedative should be considered.
Remimazolam is associated with fast onset and offset of sedation. 5 minutes after the initial bolus and patients became fully alert 12 - 14 minutes from last dose of remimazolam. 5). 5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg.
5 mg. 5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg. 5 mg. 4. g. 50 micrograms fentanyl or a suitably reduced dose for elderly or debilitated patients. 1. # American Society of Anesthesiologists Physical Status Special populations Elderly, ASA-PS III-IV patients and patients with body weight <50 kg Elderly patients and patients with ASA-PS III-IV may be more sensitive to the effects of sedatives.
4). Renal impairment No dosage adjustment is required in any grade of renal impairment (including patients with glomerular filtration rate [GFR] <15 mL/min). 2). No dose adjustment is recommended for patients with mild (Child-Pugh scores 5 and 6) or moderate (Child-Pugh scores 7 to 9) hepatic impairment.
In patients with severe hepatic impairment (Child-Pugh scores 10 to 15; data from only 3 subjects in clinical trials), the clinical effects may be more pronounced and last longer than in healthy subjects. 4). Paediatric population The safety and efficacy of remimazolam in children and adolescents aged 0 to 18 years have not yet been established.
No data are available. Method of administration Remimazolam is for intravenous use. 9%) solution for injection. 6.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 13, 2026[1]

8%). 4). Tabulated list of adverse reactions Adverse reactions associated with intravenous remimazolam observed in controlled clinical trials in procedural sedation and the postmarketing setting are tabulated below in Table 2. Frequency groupings are as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from available data).
Table 2:
Tabulated list of adverse reactions Immune system disorders Not known Anaphylactic reaction Nervous system disorders Common Common Uncommon Headache Dizziness Somnolence Cardiac disorders Common Bradycardia1* Vascular disorders Very common Hypotension2* Respiratory, thoracic and mediastinal disorders Very common Uncommon Respiratory Depression3* Hiccups Gastrointestinal disorders Common Common Nausea Vomiting General disorders and administration site conditions Uncommon Uncommon Chills Feeling Cold 1 Bradycardia covers the following identified events: bradycardia, sinus bradycardia, and heart rate decreased.
2 Hypotension covers the following identified events: hypotension, diastolic hypotension, blood pressure decreased, blood pressure decreased systolic, and blood pressure decreased diastolic. 3 Respiratory depression covers the following identified events: hypoxia, respiratory rate decreased, respiratory acidosis, bradypnoea, dyspnoea, oxygen saturation decreased, breath sounds abnormal, hypopnoea, respiratory depression, and respiratory distress.
0%) than patients below 65 years old. 8%) than patients with ASA-PS I-II. Older age and higher ASA-PS were not associated with a higher frequency of bradycardia. 4. Patients with hepatic impairment Respiratory depression (hypoxia/oxygen saturation decreased) was reported in 2 of 8 subjects with moderate hepatic impairment, and 1 of 3 with severe hepatic impairment enrolled in a dedicated trial assessing remimazolam in hepatic impairment.
2. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised March 13, 2026[1]

Cardiorespiratory adverse reactions Cardiorespiratory adverse reactions have been reported with the use of remimazolam, including respiratory depression, bradycardia and hypotension. Remimazolam administration can be associated with a transient increase in heart rate (10-20 beats per minute) starting as early as 30 seconds after the start of dosing (corresponding to the time of maximum concentration of remimazolam) before resolving within about 30 minutes after the end of administration.
This increase in heart rate coincides with a decrease in blood pressure and it may confound QT correction for heart rate translating into a small prolongation in QTcF in the first few minutes following dosing. 2). Concomitant use of opioids Concomitant use of remimazolam and opioids may result in profound sedation, respiratory depression, coma and death.
In patients with longer-term opioid use, caution is advised; it should not be presumed that these effects will be attenuated. See monitoring section below. Concomitant use of alcohol / CNS depressants The concomitant use of remimazolam with alcohol or/and CNS depressants should be avoided.
Alcohol intake should be avoided for 24 hours before remimazolam administration. Such concomitant use has the potential to increase the clinical effects of remimazolam, possibly including severe sedation or clinically relevant respiratory depression.
See monitoring section below. , for insomnia or anxiety disorders) may develop tolerance to the sedative effects of remimazolam. Hence, a larger cumulative dose of remimazolam may be required to achieve the desired level of sedation.
2 and titrate up based on the patient’s sedation-response, until the desired depth of sedation is achieved. See monitoring section below. Monitoring Remimazolam should be administered only by health care professionals experienced in sedation who are not involved in conducting the procedure, in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function.
2). Patients should be monitored closely during and after the procedure for signs and symptoms of respiratory depression and sedation. 1), but that this may vary in individual patients. Patients should be closely monitored until they are judged by the healthcare professional to be sufficiently recovered.

This is not medical advice. Consult a qualified healthcare professional.

Remimazolam must only be administered by healthcare professionals experienced in sedation. The patient should be monitored throughout by a separate healthcare professional, who is not involved in the conduct of the procedure, and whose sole task is to monitor the patient.
This personnel must be trained in the detection and management of airway obstruction, hypoventilation and apnoea, including the maintenance of a patent airway, supportive ventilation and cardiovascular resuscitation. The patient´s respiratory and cardiac function must be continuously monitored.
Resuscitative medicinal products and age- and size-appropriate equipment for restoring airway patency and bag/valve/mask ventilation must be immediately available. A benzodiazepine reversal medicinal product (flumazenil) must be immediately available for use.
Posology Remimazolam dosing should be individually titrated to an effective dose which provides the desired level of sedation and minimises adverse reactions (see Table 1). Additional doses can be administered as needed to induce or maintain the desired level of sedation.
At least 2 minutes should elapse prior to administration of any supplemental dose in order to fully assess the sedative effect. If 5 doses of remimazolam within 15 minutes do not result in the desired level of sedation then an additional or another sedative should be considered.
Remimazolam is associated with fast onset and offset of sedation. 5 minutes after the initial bolus and patients became fully alert 12-14 minutes from last dose of remimazolam. 5). 5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg.
5 mg. 5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg. 5 mg. 4. g. 50 micrograms fentanyl or a suitably reduced dose for elderly or debilitated patients. 1. # American Society of Anesthesiologists Physical Status Special populations Elderly, American Society of Anesthesiologists Physical Status (ASA-PS) III-IV patients and patients with body weight < 50 kg Elderly patients and patients with ASA-PS III-IV may be more sensitive to the effects of sedatives.
4). Renal impairment No dosage adjustment is required in any grade of renal impairment (including patients with glomerular filtration rate [GFR] < 15 mL/min). 2). No dose adjustment is recommended for patients with mild (Child-Pugh scores 5 and 6) or moderate (Child-Pugh scores 7 to 9) hepatic impairment.
In patients with severe hepatic impairment (Child-Pugh scores 10 to 15; data from only 3 subjects in clinical trials), the clinical effects may be more pronounced and last longer than in healthy subjects. 4). 4 Paediatric population The safety and efficacy of remimazolam in children and adolescents aged 0 to ˂18 years have not yet been established.
No data are available. Method of administration Remimazolam is for intravenous use. 9%) solution for injection. 6.