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Temazepam
Restoril (temazepam) is a small molecule pharmaceutical. Temazepam was first approved as Restoril on 1982-01-01. It is used to treat depressive disorder, panic disorder, and 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
Restoril (generic drugs available since 1987-04-21, discontinued: Temaz)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Temazepam
Tradename
Company
Number
Date
Products
RESTORILSPECGXN-018163 RX1982-01-01
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
restorilNew Drug Application2021-02-11
temazepamANDA2023-06-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
depressive disorderEFO_1002014D003866F32.A
panic disorderEFO_0004262D016584F41.0
sleep initiation and maintenance disorders—D007319F51.01
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
— N05CD07: Temazepam
HCPCS
No data
Clinical
Clinical Trials
16 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-positive bacterial infectionsD016908—3—1—4
Chronic kidney failureD007676EFO_0003884N18.61——1—2
Cystic fibrosisD003550EFO_0000390E84———1—1
Chronic renal insufficiencyD051436N18———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial pneumoniaD018410EFO_1001272J15.9——2—13
BacteremiaD016470EFO_0003033R78.81—11——2
Staphylococcal skin infectionsD013207EFO_1001849L00——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wound infectionD014946—1———1
AbscessD000038EFO_0003030—1———1
UlcerD014456MPATH_579—1———1
BurnsD002056T30.0—1———1
CellulitisD002481EFO_0003035L03.90—1———1
InfectionsD007239EFO_0000544—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Kidney diseasesD007674EFO_0003086N081————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTEMAZEPAM
INNtemazepam
Description
Temazepam is a benzodiazepine.
Classification
Small molecule
Drug classantianxiety agents (diazepam type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1C(=O)C(O)N=C(c2ccccc2)c2cc(Cl)ccc21
Identifiers
PDB—
CAS-ID846-50-4
RxCUI10355
ChEMBL IDCHEMBL967
ChEBI ID9435
PubChem CID5391
DrugBankDB00231
UNII IDCHB1QD2QSS (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 179 documents
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Safety
Black-box Warning
Black-box warning for: Restoril
Adverse Events
Top Adverse Reactions
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198 adverse events reported
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