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Drug ReportsDoxepin
Doxepin
Doxepin, Silenor, Zonalon (doxepin) is a small molecule pharmaceutical. Doxepin was first approved as Doxepin hydrochloride on 1982-01-01. It is used to treat anxiety disorders, atopic dermatitis, depressive disorder, pain, and pruritus amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter and sodium-dependent noradrenaline transporter. In addition, it is known to target histamine H1 receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Doxepin, Silenor, Zonalon (discontinued: Doxepin, Sinequan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxepin hydrochloride
Tradename
Company
Number
Date
Products
SILENORCurrax PharmaceuticalsN-022036 RX2010-03-17
2 products, RLD, RS
ZONALONMylanN-020126 RX1994-04-01
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
doxepinANDA2024-10-03
doxepin hclANDA2024-10-16
doxepin hydrochlorideANDA2024-10-10
prudoxinNew Drug Application2017-06-29
silenorNew Drug Application2023-05-08
zonalonNew Drug Application2017-06-14
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Doxepin Hydrochloride, Silenor, Currax
85132992030-09-07U-620
95329712029-06-01DP
91078982028-05-01U-620
99077802028-04-11DP
105488712028-04-11U-620
110969202028-04-11U-620
112349542028-01-18U-620
79153072027-08-24U-620
95728142027-07-20U-620
106536602027-07-20U-620
111100742027-07-20U-620
94864372027-05-18U-620
98616072027-05-18U-620
102386202027-05-18U-620
106536622027-05-18U-620
ATC Codes
D: Dermatologicals
D04: Antipruritics, incl. antihistamines, anesthetics, etc.
D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
D04AX: Other antipruritics in atc
D04AX01: Doxepin
N: Nervous system drugs
N06: Psychoanaleptics
N06A: Antidepressants
N06AA: Non-selective monoamine reuptake inhibitors
N06AA12: Doxepin
HCPCS
No data
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PruritusD011537HP_0000989L29134
Sleep initiation and maintenance disordersD007319F51.011113
DepressionD003863F33.9112
AtrophyD00128411
Treatment-resistant depressive disorderD06121811
Major depressive disorderD003865EFO_0003761F2211
Depressive disorderD003866EFO_1002014F32.A11
Hiv infectionsD015658EFO_0000764B2011
AtaxiaD001259R27.011
Healthy volunteers/patients11
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.0112
Breast neoplasmsD001943EFO_0003869C5011
DermatitisD003872HP_0011123L30.911
RadiodermatitisD011855L5811
NeoplasmsD009369C8011
Non-small-cell lung carcinomaD00228911
Thyroid neoplasmsD013964EFO_000384111
Esophageal neoplasmsD004938C1511
Lung neoplasmsD008175HP_0100526C34.9011
SarcomaD01250911
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G2011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420T88.722
Drug interactionsD00434711
Bipolar disorderD001714EFO_0000289F30.911
Gastrointestinal diseasesD00576711
DyspepsiaD004415EFO_0008533K3011
Digestive system diseasesD004066HP_0011024K92.911
Nasopharyngeal carcinomaD00007727411
Breakthrough painD05939011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDoxepin
INNdoxepin
Description
Doxepin is a medication belonging to the tricyclic antidepressant (TCA) class of drugs used to treat major depressive disorder, anxiety disorders, chronic hives, and insomnia. For hives it is a less preferred alternative to antihistamines. It has a mild to moderate benefit for sleeping problems. It is used as a cream for itchiness due to atopic dermatitis or lichen simplex chronicus.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCC=C1c2ccccc2COc2ccccc21
Identifiers
PDB
CAS-ID1668-19-5
RxCUI
ChEMBL IDCHEMBL1628227
ChEBI ID4710
PubChem CID3158
DrugBankDB01142
UNII ID5ASJ6HUZ7D (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A4
SLC6A4
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A4
Gene synonyms
HTT, SERT
NCBI Gene ID
Protein name
sodium-dependent serotonin transporter
Protein synonyms
5-hydroxytryptamine (serotonin) transporter, 5HT transporter, 5HTT, Na+/Cl- dependent serotonin transporter, serotonin transporter 1, solute carrier family 6 (neurotransmitter transporter), member 4, solute carrier family 6 (neurotransmitter transporter, serotonin), member 4, Solute carrier family 6 member 4
Uniprot ID
Mouse ortholog
Slc6a4 (15567)
sodium-dependent serotonin transporter (Q60857)
Alternate
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Doxepin
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 4,053 documents
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Safety
Black-box Warning
Black-box warning for: Doxepin hcl, Doxepin hydrochloride
Adverse Events
Top Adverse Reactions
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5,418 adverse events reported
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