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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
| psychological phenomena | D011579 |
| mental disorders | D001523 |
| musculoskeletal and neural physiological phenomena | D055687 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| doxepin hydrochloride | ANDA | 2023-06-16 |
| silenor | New Drug Application | 2020-11-09 |
| zonalon | New Drug Application | 2017-06-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anxiety disorders | EFO_0006788 | D001008 | F41.1 |
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
| depressive disorder | EFO_1002014 | D003866 | F32.A |
| pain | EFO_0003843 | D010146 | R52 |
| pruritus | HP_0000989 | D011537 | L29 |
| psychotic affective disorders | — | D000341 | F39 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE, TEVA PHARMS | |||
| 2023-08-16 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Doxepin Hydrochloride, Silenor, Currax | |||
| 8513299 | 2030-09-07 | U-620 | |
| 9532971 | 2029-06-01 | DP | |
| 9107898 | 2028-05-01 | U-620 | |
| 9907780 | 2028-04-11 | DP | |
| 10548871 | 2028-04-11 | U-620 | |
| 11096920 | 2028-04-11 | U-620 | |
| 11234954 | 2028-01-18 | U-620 | |
| 7915307 | 2027-08-24 | U-620 | |
| 9572814 | 2027-07-20 | U-620 | |
| 10653660 | 2027-07-20 | U-620 | |
| 11110074 | 2027-07-20 | U-620 | |
| 9486437 | 2027-05-18 | U-620 | |
| 9861607 | 2027-05-18 | U-620 | |
| 10238620 | 2027-05-18 | U-620 | |
| 10653662 | 2027-05-18 | U-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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | 2 | 7 | 3 | 14 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 1 | 1 | 1 | 3 | 6 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 3 | — | 1 | — | 5 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | 1 | — | 2 |
| Pheochromocytoma | D010673 | — | — | 1 | 1 | — | 2 | ||
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | 1 | |
| Allergic rhinitis | D065631 | J30.9 | — | — | — | 1 | — | 1 | |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | — | — | 1 | — | 1 |
| Urinary bladder neck obstruction | D001748 | EFO_1000840 | N32.0 | — | — | — | 1 | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 1 | — | 1 | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 1 | — | 1 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | 1 | 2 |
| Coronary disease | D003327 | — | — | 1 | — | 1 | 2 | ||
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | 1 | — | — | 1 | |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | — | 1 | — | — | 1 |
| Paraganglioma | D010235 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | 4 | 3 | — | — | — | 6 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | 4 | — | — | — | 5 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Smoking | D012907 | EFO_0003768 | F17 | — | 1 | — | — | — | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 3 | — | — | — | — | 3 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DOXEPIN |
| INN | doxepin |
| 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 class | tricyclic compounds |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2COc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 1668-19-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1628227 |
| ChEBI ID | 4710 |
| PubChem CID | 3158 |
| DrugBank | DB01142 |
| UNII ID | 5ASJ6HUZ7D (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)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Doxepin hydrochloride
Adverse Events
Top Adverse Reactions
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7,543 adverse events reported
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