Midazolam
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam) is a small molecule pharmaceutical. Midazolam was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy. It is known to target alpha-1B adrenergic receptor and thyrotropin-releasing hormone receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Midazolam, Nayzilam (discontinued: Midazolam, Seizalam, Versed)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midazolam
Midazolam hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) | Rafa Laboratories | N-216359 RX | 2022-08-08 | 1 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| midazolam | ANDA | 2025-10-31 |
| midazolam hcl | unapproved drug other | 2016-04-06 |
| midazolam hydrochloride | ANDA | 2025-11-07 |
| midazolam in 0.8% sodium chloride | ANDA | 2025-10-15 |
| midazolam in sodium chloride | ANDA | 2025-03-02 |
| mkh dose pack | unapproved drug other | 2019-03-05 |
| mko melt dose pack | unapproved drug other | 2019-03-04 |
| n/a | New Drug Application | 2024-05-09 |
| nayzilam | New Drug Application | 2023-01-19 |
| seizalam | New Drug Application | 2023-01-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psychomotor agitation | — | D011595 | — |
| status epilepticus | EFO_0008526 | D013226 | G41 |
| anxiety disorders | EFO_0006788 | D001008 | F41.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MIDAZOLAM, NAYZILAM, UCB INC | |||
| 2026-05-17 | ODE-243 | ||
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT | |||
| 2025-09-14 | ODE-207 | ||
HCPCS
Code | Description |
|---|---|
| J2250 | Injection, midazolam hydrochloride, per 1 mg |
Clinical
Clinical Trials
1635 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 196 | 1 | 1 | 2 | 7 | 207 |
| Postoperative pain | D010149 | — | G89.18 | 2 | 6 | 5 | 15 | 33 | 57 |
| Anesthesia | D000758 | — | — | 4 | 2 | 7 | 20 | 24 | 55 |
| Neoplasms | D009369 | — | C80 | 35 | 4 | 2 | 2 | 9 | 49 |
| Delirium | D003693 | — | R41.0 | 6 | 1 | 2 | 15 | 19 | 43 |
| Depression | D003863 | — | F33.9 | 8 | 14 | 10 | 6 | 8 | 41 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 2 | 6 | 2 | 13 | 18 | 40 |
| Pain | D010146 | EFO_0003843 | R52 | 8 | 5 | 1 | 10 | 16 | 38 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 7 | 11 | 7 | 7 | 7 | 36 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 3 | 6 | 2 | 11 | 15 | 36 |
Show 277 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 9 | 3 | — | 1 | 11 |
| Hypoxia | D000860 | — | R09.02 | — | — | 2 | — | 7 | 9 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | 7 | 8 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 2 | — | 5 | 7 |
| Traumatic stress disorders | D040921 | — | — | — | 6 | 1 | — | 1 | 7 |
| Adenoma | D000236 | — | — | — | — | 1 | — | 5 | 6 |
| Renal insufficiency | D051437 | — | N19 | 3 | — | 3 | — | — | 6 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | 1 | 1 | — | 4 | 6 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | 1 | 2 | — | 2 | 6 |
| Suicide | D013405 | — | — | — | 3 | 1 | — | 1 | 5 |
Show 71 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 6 | 2 | — | — | — | 7 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 6 | 1 | — | — | — | 7 |
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | — | — | 4 | 6 |
| Dermatitis | D003872 | — | L30.9 | 5 | 1 | — | — | — | 6 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 4 | 2 | — | — | — | 5 |
| Eczema | D004485 | — | L30.9 | 4 | 1 | — | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | 2 | 1 | — | — | 2 | 4 |
| Operative surgical procedures | D013514 | — | — | — | 2 | — | — | 2 | 4 |
| Leukemia | D007938 | — | C95 | 4 | 3 | — | — | — | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | — | 4 |
Show 66 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 29 | — | — | — | 3 | 32 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 11 | — | — | — | — | 11 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 6 | — | — | — | 1 | 7 |
| Overweight | D050177 | — | E66.3 | 6 | — | — | — | — | 6 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 6 | — | — | — | — | 6 |
| Back pain | D001416 | — | M54 | 2 | — | — | — | 4 | 6 |
| Low back pain | D017116 | — | M54.5 | 2 | — | — | — | 3 | 5 |
| Melanoma | D008545 | — | — | 4 | — | — | — | — | 4 |
| Food-drug interactions | D018565 | — | — | 3 | — | — | — | 1 | 4 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | — | — | — | 1 | 4 |
Show 111 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiopulmonary bypass | D002315 | — | — | — | — | — | — | 4 | 4 |
| Airway management | D058109 | — | — | — | — | — | — | 4 | 4 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 3 | 3 |
| Thoracic surgical procedures | D019616 | — | — | — | — | — | — | 3 | 3 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 3 | 3 |
| Tachycardia | D013610 | — | R00.0 | — | — | — | — | 3 | 3 |
| Epidural analgesia | D015360 | — | — | — | — | — | — | 2 | 2 |
| Anterograde amnesia | D020324 | — | R41.1 | — | — | — | — | 2 | 2 |
| Intraoperative awareness | D058926 | — | — | — | — | — | — | 2 | 2 |
| Gastrointestinal microbiome | D000069196 | — | — | — | — | — | — | 2 | 2 |
Show 185 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Midazolam |
| INN | midazolam |
| Description | Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes. |
| Classification | Small molecule |
| Drug class | Benzodiazepine |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2 |
Identifiers
| PDB | — |
| CAS-ID | 59467-70-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL655 |
| ChEBI ID | 6931 |
| PubChem CID | 4192 |
| DrugBank | DB00683 |
| UNII ID | R60L0SM5BC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
Mouse ortholog
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—
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Midazolam
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 60,458 documents
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Safety
Black-box Warning
Black-box warning for: Midazolam, Midazolam hydrochloride, Midazolam in 0.8% sodium chloride, Midazolam in sodium chloride, N/a, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
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15,917 adverse events reported
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