Doxylamine - PharmaKB

Doxylamine

Bonjesta, Diclegis, Doxylamine, 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.

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Clinical

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Variants

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FDA approval date

EMA approval date

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Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
nervous system diseases	D009422
immune system diseases	D007154
signs and symptoms pathological conditions	D013568
mental disorders	D001523

Trade Name

FDA

EMA

Doxylamine, Unisom (discontinued: Decapryn, Doxy-sleep-aid, Doxylamine, Unisom)

Combinations

Bonjesta, Diclegis, Doxylamine pyridoxine (discontinued: Bendectin, Doxylamine pyridoxine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Doxylamine succinate

Pyridoxine hydrochloride

Tradename	Company	Number	Date	Products
BONJESTA	Duchesnay	N-209661 RX	2016-11-07	1 products, RLD, RS
DICLEGIS	Duchesnay	N-021876 RX	2013-04-08	1 products, RLD, RS

Show 1 discontinued

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
24-7 life by 7-eleven nighttime cold and flu	C200263	2024-11-21
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl	OTC monograph final	2017-07-19
acetaminophen dextromethorphan hydrobromide and doxylamine succinate	OTC monograph not final	2019-12-26
acetaminophen dextromethorphan hydrobromide doxylamine succinate phenylephrine hydrochloride	OTC monograph final	2017-06-02
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate	OTC monograph final	2023-03-25
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate	C200263	2024-09-27
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate	OTC monograph final	2010-09-01
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate	OTC monograph final	2023-03-25
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride	C200263	2024-08-26
acetaminophen,dextromethorphan,doxylamine	OTC monograph final	2016-12-04

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
headache	HP_0002315	D006261	R51
sleep initiation and maintenance disorders	—	D007319	F51.01
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
seizures	HP_0002069	D012640	G40.4
vitamin b 6 deficiency	—	D026681	E53.1

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Doxylamine Succinate / Pyridoxine Hydrochloride, Bonjesta, Duchesnay
9089489	2033-02-18	DP	U-1382
9375404	2033-02-18	DP	U-1382
9526703	2033-02-18	DP	U-1382
9937132	2033-02-18	DP	U-1382

ATC Codes

R: Respiratory system drugs

— R06: Antihistamines for systemic use

— R06A: Antihistamines for systemic use

— R06AA: Aminoalkyl ethers, systemic antihistamines

— R06AA09: Doxylamine

— R06AA59: Doxylamine, combinations

HCPCS

No data

Clinical

Clinical Trials

17 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Nausea	D009325	HP_0002018	R11.0	1	—	3	2	3	9
Vomiting	D014839	HP_0002013	R11.1	—	—	4	2	2	8
Morning sickness	D048968	—	—	—	—	1	1	—	2
Hyperemesis gravidarum	D006939	EFO_1000971	O21	—	—	1	1	—	2
Cough	D003371	HP_0012735	R05	—	—	—	1	—	1
Common cold	D003139	EFO_0007214	J00	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy complications	D011248	—	—	—	—	1	—	—	1
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	1	—	—	1
Infections	D007239	EFO_0000544	—	—	—	1	—	—	1
Communicable diseases	D003141	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	1	1	—	—	—	1
Rectal neoplasms	D012004	—	—	1	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Oral lichen planus	D017676	—	—	1	—	—	—	—	1
Lichen planus	D008010	—	L43	1	—	—	—	—	1
Biological availability	D001682	—	—	1	—	—	—	—	1
Respiratory tract infections	D012141	—	J06.9	1	—	—	—	—	1
Allergic rhinitis	D065631	—	J30.9	1	—	—	—	—	1
Rhinitis	D012220	EFO_0008521	J31	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy rate	D018873	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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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

No data

Variants

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Financial

Revenue by drug

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Estimated US medical usage

Doxylamine

Dextromethorphan

Acetaminophen

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Doxylamine

Dextromethorphan

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Doxylamine

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Doxylamine

Phenylephrine

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Doxylamine

Pseudoephedrine

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Doxylamine

Pyridoxine

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Trends

PubMed Central

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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7,388 adverse events reported

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