Last reviewed · How we verify
Versed (midazolam)
Midazolam (Versed) is the most used procedural sedation benzodiazepine, developed by Roche and approved in 1985. Rapid onset and short duration make it ideal for procedures. Available generically. WHO Essential Medicine.
At a glance
| Generic name | midazolam |
|---|---|
| Also known as | Versed, Nayzilam |
| Sponsor | Generic (originally Roche) |
| Drug class | Benzodiazepine (short-acting) |
| Target | Multidrug resistance protein 1, Cytochrome P450 3A4, GABA A receptor alpha-3/beta-2/gamma-2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1985-12-20 (United States) |
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
- Apnea
- Tenderness at intravenous site
- Pain at intramuscular injection site
- Pain during injection
- Hiccoughs
- Desaturation
- Nausea
- Vomiting
- Redness at intravenous site
- Induration at intravenous site
- Headache
Serious adverse events
- Death (cardiorespiratory depression)
- Laryngospasm
- Bronchospasm
- Airway obstruction
- Phlebitis
- Bradycardia
- Tachycardia
- Premature ventricular contractions
- Seizure
- Emergence delirium or agitation
Key clinical trials
- Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression (Phase 2)
- Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial (EARLY/Phase 1)
- Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam (Phase 4)
- A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resis (Phase 1)
- Bronchoscopy Under Titrated Sedation With Propofol or Midazolam: a Randomized Trial. (Phase 4)
- NCT01491009 (NA)
- Triage Par Intelligence Artificielle Des Patients Sollicitant Des Soins en Urgence ou Non programmés Qui nécessitent d'être orientés Vers l'hôpital (N/A)
- A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects (Phase 1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9687495 | 2028-01-18 | Formulation |
| 9289432 | 2028-01-18 | Formulation |
| 8217033 | 2028-01-18 | Formulation |
| 10966990 | 2038-06-20 | Formulation |
| 8809322 | 2028-01-18 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |