MIDOZALAM HYDROCHLORIDE (midazolam hydrochloride)
MIDOZALAM HYDROCHLORIDE is indicated for the treatment of Anxiety; Amnesia.
Details
- Status
- Prescription
- First Approved
- 2011-05-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MIDOZALAM HYDROCHLORIDE Approval History
What MIDOZALAM HYDROCHLORIDE Treats
2 indicationsMIDOZALAM HYDROCHLORIDE is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety
- Amnesia
MIDOZALAM HYDROCHLORIDE Boxed Warning
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 physici...
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 injecti
MIDOZALAM HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIDOZALAM HYDROCHLORIDE
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07569198 KET-DBT | 25-5431 | Ph 2 | not yet recruiting | Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT) |
| NCT06496750 KMD | STU-2023-1086 | Ph 2 | recruiting | Ketamine for Methamphetamine Use Disorder |
| NCT06867068 | 2014-3556 | Ph 1 | completed | Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery |
| NCT05004896 KET-BD | 21-5560 | Ph 2 | completed | Ketamine for Treatment-Resistant Bipolar Disorder |
| NCT06480500 Ket-CBT | 21-6000 | Ph 2 | recruiting | i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial |
| NCT04592809 TASK | STU-2020-0973 R01MH125181 | Ph 3 | completed | Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06090422 KeDA | 2022/484848(REK) 2023-506052-24, U1111-1293-2654 | Ph 1, Ph 2 | not yet recruiting | Ketamine for Combined Depression and Alcohol Use Disorder |
| NCT03330990 | RXDX-101-14 GO40785 | Ph 1 | completed | Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients |
| NCT03457597 | CORT125134-126 | Ph 1 | completed | Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s |
| NCT02473627 | DS1971-A-E105 | Ph 1 | completed | A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIDOZALAM HYDROCHLORIDE FDA Label Details
Indications & Usage
MIDOZALAM HYDROCHLORIDE is indicated for the treatment of Anxiety; Amnesia.
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 recog...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.