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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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Target
Variants
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YTD
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2Y
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FDA approval date
EMA approval date
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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
doxepinANDA2025-01-08
doxepin hclANDA2024-10-16
doxepin hydrochlorideANDA2025-01-03
prudoxinNew Drug Application2017-06-29
silenorNew Drug Application2023-05-08
zonalonNew Drug Application2017-06-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atopic dermatitisEFO_0000274D003876L20
pruritusHP_0000989D011537L29
painEFO_0003843D010146R52
anxiety disordersEFO_0006788D001008F41.1
psychotic affective disorders—D000341F39
depressive disorderEFO_1002014D003866F32.A
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
No data
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
6532
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
Q5EE02
Mouse ortholog
Slc6a4 (15567)
sodium-dependent serotonin transporter (Q60857)
Alternate
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Price per prescription (USD)
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Tabular view
Trends
No data
Safety
Black-box Warning
Black-box warning for: Doxepin hcl, Doxepin hydrochloride
Adverse Events
0 adverse events reported
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