Last reviewed 2026-04-20 · How we verify

Versed (Midazolam Hydrochloride)

Midazolam hydrochloride (Versed) is a benzodiazepine indicated for preoperative sedation, procedural sedation, anesthesia induction, and critical care sedation via intramuscular or intravenous routes. It demonstrates linear kinetics at lower doses with non-linear kinetics at higher doses, hepatic metabolism via CYP3A4, and approximately 97% plasma protein binding. Major risks include respiratory depression when combined with opioids or other CNS depressants, and prolonged sedation with CYP3A4 inhibitors; it is contraindicated in acute narrow-angle glaucoma and premature infants. Careful dose adjustment and monitoring are essential, particularly with concomitant CNS depressants.

At a glance

Approved indications

• Anxiety
• Conscious sedation
• Feeling agitated
• General anesthesia
• Induce Anterograde Amnesia
• Local anesthesia
• Preoperative Anxiety
• Sedation
• Sedation as Adjunct to Anesthesia
• Sedation in Intubated Patients
• Status epilepticus

Boxed warnings

• WARNINGS Personnel and Equipment for Monitoring and Resuscitation Adults and Pediatrics: Intravenous midazolam hydrochloride has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam hydrochloride should be used only in hospital or ambulatory care settings, including physicians' and dental offices, that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS ). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Risks From Concomitant Use With Opioids Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation (see WARNINGS and PRECAUTIONS ; Drug Interactions ). Individualization of Dosage Midazolam hydrochloride must never be used without individualization of dosage. The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. The use of dilution 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation/anxiolysis/amnesia is age, procedure, and route dependent (see DOSAGE AND ADMINISTRATION for complete dosing information). Neonates: Midazolam hydrochloride should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid intravenous administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information).

Common side effects

• Decreased tidal volume and/or respiratory rate decrease (IV administration)
• Decreased tidal volume and/or respiratory rate decrease (IM administration)
• Apnea (IV administration)
• Headache (IM administration)
• Injection site pain (IM)
• Induration (IM)
• Redness (IM)
• Muscle stiffness (IM)
• Hiccoughs (IV administration)
• Nausea (IV administration)
• Vomiting (IV administration)
• Coughing (IV administration)

Drug interactions

• Benzodiazepines and opioids (combined)
• CNS depressants (narcotics: morphine, meperidine, fentanyl; secobarbital; droperidol)
• Cytochrome P450-3A4 inhibitors (cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole)
• Ranitidine

Key clinical trials

• SMILE Trial - Imaging Sub-Study
• Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (PHASE1)
• A Study of LY4268989 (MORF-057) in Healthy Participants (PHASE1)
• Management of Catatonic Features in Adolescents With Profound Autism (NA)
• HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids (NA)
• A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. (PHASE1)
• Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis (PHASE1)
• A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Versed CI brief — competitive landscape report
• Versed updates RSS · CI watch RSS
• Takeda Pharmaceutical Company Limited portfolio CI