Doxylamine
Bonjesta, Diclegis, Unisom (doxylamine) is a small molecule pharmaceutical. Doxylamine was first approved as Unisom on 1982-01-01. It is used to treat allergic rhinitis perennial, headache, and sleep initiation and maintenance disorders in the USA.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Unisom (generic drugs available since 1996-09-18, discontinued: Decapryn, Doxy-sleep-aid)
CombinationsBonjesta, Diclegis (generic drugs available since 1996-09-18, discontinued: Bendectin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxylamine succinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| UNISOM | Sanofi | N-018066 OTC | 1982-01-01 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bonjesta | New Drug Application | 2021-12-21 |
| diclegis | New Drug Application | 2021-12-17 |
| doxylamine succinate and pyridoxine hydrochloride | NDA authorized generic | 2023-06-15 |
| unisom sleeptabs | ANDA | 2023-04-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| headache | HP_0002315 | D006261 | R51 |
| sleep initiation and maintenance disorders | — | D007319 | F51.01 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | F51.01 | 1 | 1 | — | 1 | — | 3 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | 1 | 2 | |
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | 1 | ||
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | — | — | 1 | |
| Urticaria | D014581 | EFO_0005531 | L50 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | — | 1 | ||
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | — | — | — | 1 | |
| Esophageal neoplasms | D004938 | C15 | — | 1 | — | — | — | 1 | |
| Sarcoma | D012509 | — | 1 | — | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Small cell lung carcinoma | D055752 | — | 1 | — | — | — | 1 | ||
| Thymoma | D013945 | — | 1 | — | — | — | 1 | ||
| Mesothelioma | D008654 | C45 | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | HP_0000989 | L29 | — | — | — | — | 3 | 3 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | 1 | 1 | ||
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | DOXYLAMINE |
| INN | doxylamine |
| Description | Doxylamine is a member of pyridines and a tertiary amine. It has a role as a histamine antagonist, a cholinergic antagonist, a sedative, an antiemetic, a H1-receptor antagonist, an anti-allergic agent and an antitussive. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCOC(C)(c1ccccc1)c1ccccn1 |
Identifiers
| PDB | — |
| CAS-ID | 469-21-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1004 |
| ChEBI ID | 51380 |
| PubChem CID | 3162 |
| DrugBank | DB00366 |
| UNII ID | 95QB77JKPL (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:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,021 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
4,438 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more