Doxylamine

Overview

Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in parkinsonism.

Indication

用于枯草热、过敏性鼻炎，短期用于失眠。

Associated Conditions

Common Cold
Insomnia
Mild Allergic Rhinitis
Nausea
Symptoms Flu
Vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy	2025/01/14	NCT06772974	Not Applicable	Not yet recruiting	Nawaz Sharif Medical College
Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers	2024/04/02	NCT06342778	Phase 1	Completed	Valenta Pharm JSC
Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy	2024/02/14	NCT06259747	Not Applicable	Completed	Kafrelsheikh University
Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers	2022/08/12	NCT05498233	Not Applicable	Completed	Valenta Pharm JSC
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions	2019/04/05	NCT03905564	Phase 1	Withdrawn	Grünenthal GmbH
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children	2008/11/24	NCT00796315	Phase 1	Completed	Procter and Gamble
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy	2008/02/13	NCT00614445	Phase 3	Completed	Duchesnay Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
NIGHTTIME COLD AND FLU	BI-MART	37835-525	ORAL	12.5 mg in 30 mL	5/1/2025
Nuvicare NightTime Cold and Flu Softgel	NUVICARE LLC	84324-019	ORAL	6.25 mg in 1 1	5/20/2025
nitetime severe	Publix Super Markets Inc	56062-763	ORAL	12.5 mg in 30 mL	5/19/2025
Doxylamine Succinate and Pyridoxine Hydrochloride	Mylan Pharmaceuticals Inc.	0378-4615	ORAL	10 mg in 1 1	1/3/2019
Night Time Cold and Flu Relief Multi Symptom	CVS Pharmacy	69842-899	ORAL	6.25 mg in 1 1	6/18/2025
NyQuil Cold and Flu w/VapoCOOL, 4ct, CVP HEALTH	Lil' Drug Store Products, Inc.	66715-6805	ORAL	6.25 mg in 1 1	6/17/2025
Doxylamine Succinate and Pyridoxine Hydrochloride	Bryant Ranch Prepack	72162-1485	ORAL	10 mg in 1 1	10/14/2020
Doxylamine succinate and Pyridoxine hydrochloride	Bionpharma Inc.,	69452-206	ORAL	10 mg in 1 1	12/11/2023
topcare sleep aid	Topco Associates LLC	76162-603	ORAL	25 mg in 1 1	3/26/2025
Doxylamine succinate and pyridoxine hydrochloride	Actavis Pharma, Inc.	0591-2132	ORAL	10 mg in 1 1	10/24/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DICLECTIN DELAYED RELEASE TABLETS 10MG/10MG	Duchesnay Inc.	SIN15301P	TABLET, DELAYED RELEASE	10mg	7/20/2017
BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG	Duchesnay Inc.	SIN16865P	TABLET, FILM COATED, EXTENDED RELEASE	20.0mg	9/18/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CIPLA PAIN RELIEF PARACETAMOL + CODEINE with CALMATIVE tablet blister pack	140610	Cipla Australia Pty Ltd	Medicine	A	6/20/2007
DOZAVIT doxylamine succinate 25 mg tablet blister pack	340137	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	7/24/2020
RESTEASE doxylamine succinate 25mg tablet blister pack	400390	AUBEX PHARMA Pty Ltd	Medicine	A	11/30/2022
RESTAVIT doxylamine succinate 25 mg tablet blister pack	13336	H W Woods Pty Ltd	Medicine	A	8/21/1991
DOZILE TABLETS doxylamine succinate 25 mg tablet blister pack	143861	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	8/23/2007
NOUMED DOXYLAMINE doxylamine succinate tablet blister pack	78552	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	5/28/2001
MEDREICH PARACETAMOL 500 MG CODEINE PHOSPHATE 10 MG AND DOXYLAMINE SUCCINATE 5.1 MG TABLETS blister pack	202702	Medreich Australia Pty Ltd	Medicine	A	11/5/2012
AMCAL DOXY SLEEP-AID doxylamine succinate 25 mg tablet blister pack (New Formulation)	234393	Cipla Australia Pty Ltd	Medicine	A	3/3/2015
GUARDIAN DOXY SLEEP-AID doxylamine succinate 25 mg tablet blister pack	467292	Neo Health (OTC) Pty Ltd	Medicine	A	11/5/2024
GOLD CROSS SLEEPWELL doxylamine succinate 25mg tablet blister pack	171259	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	5/11/2010

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SINUS MEDICATION EXTRA STRENGTH NIGHT TIME	Pharmascience Inc	02246847	Tablet - Oral	6.25 MG	12/8/2002
MERCODOL WITH DECAPRYN	aventis pharma inc	02048183	Syrup - Oral	6 MG / 5 ML	12/31/1994
NYQUIL LIQUICAPS	procter & gamble inc	01996215	Capsule - Oral	6.25 MG / CAP	12/31/1993
NYQUIL VAPOCOOL COLD & FLU	procter & gamble inc	02553775	Syrup - Oral	12.5 MG / 30 ML	N/A
NYQUIL COMPLETE	procter & gamble inc	02503549	Syrup - Oral	12.5 MG / 30 ML	7/19/2021
COLD & FLU RELIEF NIGHTTIME	vita health products inc	02306344	Capsule - Oral	6.25 MG	N/A
COLD & SINUS LIQUID CAPSULES	vita health products inc	02427958	Kit , Capsule - Oral	6.25 MG	6/1/2016
COLD AND FLU MEDICINE - NIGHT TIME FORMULA	pharmetics (2011) inc	02271672	Capsule - Oral	6.25 MG	4/10/2006
VICKS NYQUIL COUGH	procter & gamble inc	02244662	Liquid - Oral	6.25 MG / 15 ML	8/19/2010
TEVA-DOXYLAMINE/PYRIDOXINE DR	teva canada limited	02304503	Tablet (Delayed-Release) - Oral	10 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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