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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estazolam
Tradename
Company
Number
Date
Products
PROSOMAbbott BiotherapeuticsN-019080 DISCN1990-12-26
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
estazolamANDA2022-11-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep initiation and maintenance disordersD007319F51.01
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05C: Hypnotics and sedatives
N05CD: Benzodiazepine derivative hypnotics and sedatives
N05CD04: Estazolam
HCPCS
No data
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 refluxD005764EFO_0003948K2181322311283
InfectionsD007239EFO_000054412321146
Healthy volunteers/patients3611542
DyspepsiaD004415EFO_0008533K3026410121
EsophagitisD004941HP_0100633K20127515
GastritisD005756EFO_0000217K29.72135314
Peptic ulcerD010437HP_0004398K273126113
Stomach ulcerD013276K2582111
HeartburnD006356R12113711
Barrett esophagusD001471EFO_0000280K22.711327
Show 29 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pre-eclampsiaD011225EFO_0000668O1411225
Duodenal ulcerD004381EFO_0004607K26314
AsthmaD001249EFO_0000270J45213
Gastrointestinal hemorrhageD006471K92.2123
Gastrointestinal diseasesD005767123
Eosinophilic esophagitisD057765EFO_0004232K20.01112
Esophageal neoplasmsD004938C15112
ArthritisD001168EFO_0005856M05-M14112
Type 2 diabetes mellitusD003924EFO_0001360E11112
HemorrhageD006470MP_0001914R5822
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autism spectrum disorderD000067877F84.0112
Replacement arthroplasty kneeD01964511
NeuralgiaD009437EFO_000943011
Autistic disorderD001321EFO_0003758F84.011
Deglutition disordersD003680HP_0002015R13.111
Cystic fibrosisD003550EFO_0000390E8411
Gram-negative bacterial infectionsD01690511
Tooth erosionD014077K03.2111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599415
NeoplasmsD009369C8022
Therapeutic equivalencyD01381011
Breast neoplasmsD001943EFO_0003869C5011
Pulmonary hypertensionD006976EFO_0001361I27.2011
Pulmonary arterial hypertensionD00008102911
Chronic hepatitis bD019694EFO_0004197B18.111
LymphomaD008223C85.911
Juvenile arthritisD001171EFO_0002609M0811
HomeostasisD00670611
Show 4 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PyloromyotomyD00007488211
Calcium metabolism disordersD002128EFO_0005769E83.511
RadiotherapyD01187811
MortalityD009026EFO_000435211
HemostasisD00648711
Vasomotor rhinitisD012223EFO_0007533J30.011
Esophageal achalasiaD004931HP_0002571K22.011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameESTAZOLAM
INNestazolam
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-ID29975-16-4
RxCUI4077
ChEMBL IDCHEMBL285674
ChEBI ID4858
PubChem CID3261
DrugBankDB01215
UNII ID36S3EQV54C (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 822 documents
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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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