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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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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
Silenor, Zonalon (generic drugs available since 1986-05-13, discontinued: 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
doxepin hydrochlorideANDA2023-06-16
silenorNew Drug Application2020-11-09
zonalonNew Drug Application2017-06-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anxiety disordersEFO_0006788D001008F41.1
atopic dermatitisEFO_0000274D003876L20
depressive disorderEFO_1002014D003866F32.A
painEFO_0003843D010146R52
pruritusHP_0000989D011537L29
psychotic affective disordersD000341F39
Agency Specific
FDA
EMA
Expiration
Code
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE, TEVA PHARMS
2023-08-16CGT
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
50 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101227314
Prostatic hyperplasiaD011470EFO_0000284N4011136
Post-traumatic stress disordersD013313EFO_0001358F43.11315
Diabetes mellitusD003920EFO_0000400E08-E13112
PheochromocytomaD010673112
Diabetic nephropathiesD003928EFO_000040111
Allergic rhinitisD065631J30.911
Dilated cardiomyopathyD002311EFO_0000407I42.011
Urinary bladder neck obstructionD001748EFO_1000840N32.011
Overactive urinary bladderD053201EFO_1000781N32.8111
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I981113
Heart diseasesD006331EFO_0003777I51.91113
Myocardial infarctionD009203EFO_0000612I21112
Coronary diseaseD003327112
Heart failureD006333EFO_0003144I5011
HypercholesterolemiaD006937HP_000312411
Myocardial ischemiaD017202EFO_1001375I20-I2511
Kidney calculiD007669EFO_0004253N20.011
ParagangliomaD01023511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F14436
AlcoholismD000437EFO_0003829F10.1145
Vascular diseasesD014652EFO_0004264I7711
SmokingD012907EFO_0003768F1711
AnxietyD001007EFO_0005230F41.111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F1333
Erectile dysfunctionD007172EFO_0004234F52.2111
Healthy volunteers/patients11
Amphetamine-related disordersD019969EFO_0004701F1511
Mood disordersD019964EFO_0004247F30-F3911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Microvascular anginaD01756611
UrolithiasisD052878N20-N2311
Urinary retentionD016055HP_0000016R3311
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)
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,635 documents
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Safety
Black-box Warning
Black-box warning for: Doxepin hydrochloride
Adverse Events
Top Adverse Reactions
Mock data
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7,543 adverse events reported
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