Estazolam
Prosom (estazolam) is a small molecule pharmaceutical. Estazolam was first approved as Prosom on 1990-12-26. It is used to treat sleep initiation and maintenance disorders in the USA.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estazolam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROSOM | Abbott Biotherapeutics | N-019080 DISCN | 1990-12-26 | 2 products, RLD |
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EMA
Brand Name | Status | Last Update |
|---|---|---|
| estazolam | ANDA | 2022-11-14 |
Agency Specific
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Patent Expiration
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Clinical
Clinical Trials
361 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 8 | 13 | 22 | 31 | 12 | 83 |
| Infections | D007239 | EFO_0000544 | 1 | — | 2 | 32 | 11 | 46 | |
| Healthy volunteers/patients | — | 36 | 1 | 1 | 5 | — | 42 | ||
| Dyspepsia | D004415 | EFO_0008533 | K30 | 2 | 6 | 4 | 10 | 1 | 21 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 2 | 7 | 5 | — | 15 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 2 | 1 | 3 | 5 | 3 | 14 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | 3 | 1 | 2 | 6 | 1 | 13 |
| Stomach ulcer | D013276 | K25 | — | — | 8 | 2 | 1 | 11 | |
| Heartburn | D006356 | R12 | 1 | 1 | 3 | 7 | — | 11 | |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | 1 | — | 3 | 2 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 2 | — | 2 | 5 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | — | 3 | — | 1 | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | — | 3 |
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | 1 | 2 | — | — | 3 | |
| Gastrointestinal diseases | D005767 | 1 | — | 2 | — | — | 3 | ||
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | 1 | — | 1 | 2 |
| Esophageal neoplasms | D004938 | C15 | — | 1 | 1 | — | — | 2 | |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | — | 1 | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 1 | — | — | — | 2 | |
| Replacement arthroplasty knee | D019645 | — | 1 | — | — | — | 1 | ||
| Neuralgia | D009437 | EFO_0009430 | — | 1 | — | — | — | 1 | |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 1 | — | — | — | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Gram-negative bacterial infections | D016905 | — | 1 | — | — | — | 1 | ||
| Tooth erosion | D014077 | K03.2 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 4 | — | — | — | 1 | 5 | ||
| Neoplasms | D009369 | C80 | 2 | — | — | — | — | 2 | |
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | 1 | — | — | — | — | 1 |
| Homeostasis | D006706 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyloromyotomy | D000074882 | — | — | — | — | 1 | 1 | ||
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Radiotherapy | D011878 | — | — | — | — | 1 | 1 | ||
| Mortality | D009026 | EFO_0004352 | — | — | — | — | 1 | 1 | |
| Hemostasis | D006487 | — | — | — | — | 1 | 1 | ||
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | — | — | 1 | 1 |
| Esophageal achalasia | D004931 | HP_0002571 | K22.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ESTAZOLAM |
| INN | estazolam |
| Description | Estazolam is a triazolo[4,3-a][1,4]benzodiazepine having a phenyl group at position 6 and a chloro substituent at position 8. A short-acting benzodiazepine with general properties similar to diazepam, it is given by mouth as a hypnotic in the short-term management of insomnia. It has a role as an anxiolytic drug, an anticonvulsant and a GABA modulator. It is a member of triazoles and a triazolobenzodiazepine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccc2c(c1)C(c1ccccc1)=NCc1nncn1-2 |
Identifiers
| PDB | — |
| CAS-ID | 29975-16-4 |
| RxCUI | 4077 |
| ChEMBL ID | CHEMBL285674 |
| ChEBI ID | 4858 |
| PubChem CID | 3261 |
| DrugBank | DB01215 |
| UNII ID | 36S3EQV54C (ChemIDplus, GSRS) |
Target
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Alternate
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Variants
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Trends
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Safety
Black-box Warning
Black-box warning for: Estazolam
Adverse Events
Top Adverse Reactions
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66,896 adverse events reported
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