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Drug ReportsEstazolam
Estazolam
Estazolam (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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Financial
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Safety
Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Estazolam (discontinued: Prosom)
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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FDA
EMA
Brand Name
Status
Last Update
estazolamANDA2024-02-05
Indications
FDA
EMA
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
10 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319—F51.01——1236
Drug-related side effects and adverse reactionsD064420—T88.7———1—1
Renal dialysisD006435EFO_0010690Z99.2———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509———1———1
Alveolar soft part sarcomaD018234———1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain injuriesD001930—S06.9————11
Cognitive dysfunctionD060825HP_0001268G31.84————11
Sleep wake disordersD012893—G47————11
ParasomniasD020447—G47.5————11
Chinese traditional medicineD008516——————11
Circadian rhythmD002940EFO_0004354—————11
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—
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Structure (InChI/SMILES or Protein Sequence)
Clc1ccc2c(c1)C(c1ccccc1)=NCc1nncn1-2
Identifiers
PDB—
CAS-ID29975-16-4
RxCUI—
ChEMBL IDCHEMBL285674
ChEBI ID4858
PubChem CID3261
DrugBankDB01215
UNII ID36S3EQV54C (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Estazolam
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 991 documents
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Safety
Black-box Warning
Black-box warning for: Estazolam
Adverse Events
Top Adverse Reactions
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693 adverse events reported
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