Zopiclone

Overview

Zopiclone is a novel hypnotic agent used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors. In addition to zopiclone's benzodiazepine pharmacological properties it also has some barbiturate-like properties.

Indication

For the short-term treatment of insomnia.

Associated Conditions

Insomnia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women	2024/01/23	NCT06219902	Phase 1	Completed	Bayer
A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects	2023/04/19	NCT05819710	Phase 1	Completed	Taisho Pharmaceutical Co., Ltd.
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients	2022/03/14	NCT05277038	N/A	Completed	Salem Anaesthesia Pain Clinic
A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects	2021/01/06	NCT04696952	Phase 1	Completed	Taisho Pharmaceutical Co., Ltd.
A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder	2020/06/30	NCT04451187	Phase 1	Completed	Janssen Research & Development, LLC
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects	2019/03/27	NCT03892902	Phase 1	Completed	Idorsia Pharmaceuticals Ltd.
Hangover and Residual Zopiclone Effect on Spatial Perception	2018/08/15	NCT03632408	Phase 1	UNKNOWN	Petri Vainio
Efficacy of Multimodal Analgesia Following Hip Arthroscopy	2017/11/22	NCT03351439	Not Applicable	Completed	Western University, Canada
Effectiveness of BBT-I and Zopiclone for Chronic Insomnia	2017/11/13	NCT03339583	Phase 2	Completed	I.M. Sechenov First Moscow State Medical University
Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance	2016/07/01	NCT02820441	Phase 4	Terminated	University Hospital, Grenoble

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
IMOVANE TABLET 7.5 mg	Opella Healthcare International SAS	SIN05047P	TABLET, FILM COATED	7.5 mg	5/26/1988
ZOPICLONE TABLET 7.5 mg	DRAGENOPHARM APOTHEKER PUSCHL GMBH & CO KG	SIN11416P	TABLET	7.5 mg	10/27/2000
APO-ZOPICLONE TABLET 7.5 mg	APOTEX INC	SIN09355P	TABLET, FILM COATED	7.5 mg	5/28/1997

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
ZOPICLON STADA TAB 7.5MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	5/18/2001
GOOD-KNIGHT TAB 7.5MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	5/13/2005
GENCLONE F.C.T. TAB 7.5MG	N/A	HIND WING COMPANY LIMITED	N/A	N/A	6/29/2001
ZOPITABS TABLETS 7.5MG	N/A	PRUDENTLINK LIMITED	N/A	N/A	12/1/2017
IMOVANE TAB 7.5MG	N/A	Sanofi Hong Kong Limited	N/A	N/A	11/10/1988
NEO-CONE TAB 7.5MG	N/A	JEAN-MARIE PHARMACAL COMPANY LIMITED	N/A	N/A	8/8/2001
INSOMA 7.5 TABLETS 7.5MG	N/A	R. MANSTIEN (AUSTRALIA) LIMITED	N/A	N/A	7/11/2017
ZOPICLONE TAB 7.5MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	8/24/2001
ZOPIVANE TAB 7.5MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	10/28/2011

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APO-Zopiclone zopiclone 7.5mg tablet blister pack	213071	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/4/2014
PHARMACY CLINICE ZOPICLONE zopiclone 7.5mg tablet blister pack	213070	Ipca Pharma (Australia) Pty Ltd	Medicine	A	9/4/2014
ZOPICLONE-WGR zopiclone 7.5 mg tablet blister pack	213075	GM Pharma International Pty Ltd	Medicine	A	9/4/2014
ZOPICLONE SANDOZ zopiclone 7.5mg tablet blister pack	433710	Ipca Pharma (Australia) Pty Ltd	Medicine	A	5/29/2024
ZOPICLONE GH zopiclone 7.5mg tablet blister pack	239214	Generic Health Pty Ltd	Medicine	A	7/5/2016
GenRX Zopiclone zopiclone 7.5mg tablet blister pack	213072	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/4/2014
IMOVANE zopiclone 7.5 mg tablet blister pack	165934	Sanofi-Aventis Australia Pty Ltd	Medicine	A	11/9/2009
PHARMACOR ZOPICLONE zopiclone 7.5mg tablet blister pack	239215	Pharmacor Pty Ltd	Medicine	A	7/5/2016
IMOCLONE zopiclone 7.5mg tablet blister pack	292090	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/14/2017
IPCLONE zopiclone 7.5mg tablet blister pack	239216	Ipca Pharma (Australia) Pty Ltd	Medicine	A	7/5/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ZOPICLONE	altamed pharma	02468492	Tablet - Oral	5 MG	8/7/2018
NRA-ZOPICLONE	nora pharma inc	02477378	Tablet - Oral	5 MG	8/30/2018
ZOPICLONE TABLETS	nora pharma inc	02492407	Tablet - Oral	3.75 MG	9/29/2020
ZOPICLONE	angita pharma inc.	02557231	Tablet - Oral	5 MG	N/A
SANDOZ ZOPICLONE TABLET	Sandoz Canada, Inc.	02008203	Tablet - Oral	7.5 MG	12/31/1996
PMS-ZOPICLONE	Pharmascience Inc	02240606	Tablet - Oral	7.5 MG	8/4/1999
NTP-ZOPICLONE	teva canada limited	02381818	Tablet - Oral	5 MG	N/A
JAMP ZOPICLONE	Jamp Pharma Corporation	02549298	Tablet - Oral	5 MG	N/A
ACT ZOPICLONE	teva canada limited	02271931	Tablet - Oral	5 MG	11/11/2005
M-ZOPICLONE	mantra pharma inc	02467941	Tablet - Oral	5 MG	4/16/2018

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DATOLAN 7,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Faes Farma S.A.	58549	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZOPICLONA GRINDEKS 7,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Grindeks As	89867	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZOPICLONA GRINDEKS 3,75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Grindeks As	89866	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LIMOVAN 7,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Sanofi Aventis S.A.	58538	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ZOPICLONA GRINDEKS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Grindeks As	89865	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZOPICLONA QUALIGEN 7,5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Neuraxpharm Spain S.L.	76243	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

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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