Last reviewed 2026-04-20 · How we verify

Midazolam injection

Midazolam injection, marketed by Abliva AB, is indicated for the treatment of Status Epilepticus. The drug's key composition patent is set to expire in 2028, providing a period of market exclusivity. The primary risk is the lack of reported revenue and key trial results, which may affect investor confidence and market adoption.

At a glance

Approved indications

• Status Epilepticus

Boxed warnings

• WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS 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 (5.1), Drug Interactions (7.1)]. The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with a n increased frequency of serious adverse outcomes. Before prescribing Midazolam Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2)]. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although Midazolam Injection is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2)], if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Midazolam Injection may precipitate acute withdrawal reactions, which can be life-threatening. For patients using Midazolam Injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Midazolam Injection [see Warnings and Precautions (5.3)]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation. (5.1, 7.1) The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing Midazolam Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. (5.2) Although Midazolam Injection is indicated only for intermitt ent use (1, 2), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Midazolam Injection may precipitate acute withdrawal reactions, which can be lifethreatening. For patients using Midazolam Injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Midazolam Injection. (5.3)

Common side effects

• Upper airway obstruction
• Agitation
• Pyrexia
• Decreased tidal volume and/or respiratory rate decrease
• Pain at IM injection site
• Headache
• Induration at IM injection site
• Redness at IM injection site
• Muscle stiffness at IM injection site
• Variations in blood pressure
• Variations in pulse rate

Serious adverse events

• Respiratory depression
• Cardiorespiratory adverse reactions
• Oxygenation and ventilation complications
• Dependence and withdrawal reactions
• Neonatal sedation and withdrawal syndrome

Drug interactions

• Benzodiazepines and Opioids
• Other CNS Depressants and Alcohol
• Cytochrome P450-3A4 Inhibitors

Key clinical trials

• SMILE Trial - Imaging Sub-Study
• Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (PHASE1)
• Management of Catatonic Features in Adolescents With Profound Autism (NA)
• A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. (PHASE1)
• Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy (PHASE3)
• Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects (PHASE1)
• Propofol vs Remifentanil for Sedation in Gastroscopy (NA)
• Effect of Dexamethasone on CYP Enzyme Activity in Healthy Male Subjects (PHASE1)

Primary sources

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