Molecule
Remimazolam is a prescription medicine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It is available as powder for injection for intravenous use. MedsAcross supplies Remimazolam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
BYFAVO ® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Source: US FDA prescribing information
BYFAVO is a benzodiazepine. BYFAVO binds to brain benzodiazepine sites (gamma amino butyric acid type A [GABA A ] receptors), while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. BYFAVO, like other benzodiazepines, did not show clear selectivity between subtypes of the GABA A receptor.
Source: US FDA prescribing information
Individualize and titrate BYFAVO dosing to desired clinical effect. Adult Patients: Administer an initial dose intravenously as a 5 mg push injection over a 1-minute time period. If necessary, administer supplemental doses of 2.5 mg intravenously over a 15-second time period. At least 2 minutes must elapse prior to the administration of any supplemental dose. ASA III-IV Patients (at the discretion of the physician): Based on the general condition of the patient, administer 2.5 mg to 5 mg over 1-minute time period. If necessary, administer supplemental doses of 1.25 mg to 2.5 mg intravenously over a 15-second time period.
Source: US FDA prescribing information
BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Hypersensitivity to dextran 40.
Source: US FDA prescribing information
Boxed warning: Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Hypersensitivity Reactions: Hypersensitivity reactions including anaphylaxis may occur. Neonatal Sedation and Withdrawal Syndrome: Receiving benzodiazepines during pregnancy can result in neonatal sedation and/or neonatal withdrawal. Pediatric Neurotoxicity: In developing animals, exposures greater than 3 hours cause neurotoxicity. Weigh benefits against potential risks when considering elective procedures in children under 3 years old.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections: Neonatal Sedation and Withdrawal Syndrome The most common adverse reactions (>10%) in patients receiving BYFAVO for procedural sedation are hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.
Source: US FDA prescribing information
Opioid Analgesics and Other Sedative-Hypnotics The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including opioid analgesics, other benzodiazepines, and propofol. Continuously monitor vital signs during sedation and through the recovery period. Titrate the dose of BYFAVO when administered with opioid analgesics and sedative-hypnotics to the desired clinical response.
Source: US FDA prescribing information
Store at controlled room temperature 20°C to 25°C (68°F to 77°F) excursions between 15° and 30°C (59° and 86°F) are allowed. Reconstituted BYFAVO can be stored in the vial for up to 8 hours under controlled room temperature at 20°C to 25°C (68°F to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Remimazolam, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Byfavo 2.5 mg/mL powder for injectionIntravenous | Acacia Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Remimazolam and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Remimazolam, including Byfavo.
Yes. The US FDA first approved Remimazolam on 2 July 2020, according to Drugs@FDA.
Yes. Remimazolam has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Remimazolam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Remimazolam is classified under ATC code N05CD14 (Remimazolam).
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