Lorazepam

Overview

Lorazepam is a short-acting and rapidly cleared benzodiazepine used commonly as a sedative and anxiolytic. It was developed by DJ Richards, presented and marketed initially by Wyeth Pharmaceuticals in the USA in 1977. The first historic FDA label approval is reported in 1985 by the company Mutual Pharm.

Indication

Lorazepam is FDA-approved for the short-term relief of anxiety symptoms related to anxiety disorders and anxiety associated with depressive symptoms such as anxiety-associated insomnia. It is as well used as an anesthesia premedication in adults to relieve anxiety or to produce sedation/amnesia and for the treatment of status epilepticus. Some off-label indications of lorazepam include rapid tranquilization of an agitated patient, alcohol withdrawal delirium, alcohol withdrawal syndrome, muscle spasms, insomnia, panic disorder, delirium, chemotherapy-associated anticipatory nausea and vomiting, and psychogenic catatonia.

Associated Conditions

Agitation
Alcohol Withdrawal Delirium
Alcohol Withdrawal Syndrome
Anxiety
Anxiety Disorders
Chemotherapy-Induced Nausea and Vomiting
Delirium
Insomnia
Muscle Spasms
Panic Disorder
Psychogenic Catatonia
Status Epilepticus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia	2025/06/12	NCT07017452	Phase 3	Not yet recruiting	University of Manitoba
Computational Assessment of GABA Receptor Modulation in PTSD	2025/02/28	NCT06852469	Phase 4	Recruiting	VA Office of Research and Development
HPV Vaccine Reduced Dose	2025/01/29	NCT06799494	Phase 4	Recruiting	Emory University
Acute Agitation in Emergency Psychiatry	2024/12/30	NCT06752616	Phase 2	Recruiting	Lone Baandrup
Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study	2024/07/11	NCT06496854	Phase 2	Not yet recruiting	University of Wisconsin, Madison
Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult	2024/04/17	NCT06370442	Phase 3	Not yet recruiting	State University of New York - Upstate Medical University
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder	2023/10/23	NCT06093451	Phase 4	Recruiting	Temple University
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression	2023/08/22	NCT06004115	Phase 4	Recruiting	Laureate Institute for Brain Research, Inc.
Therapies for Down Syndrome Regression Disorder	2022/12/22	NCT05662228	Phase 2	Recruiting	University of Colorado, Denver
A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems	2022/10/31	NCT05599126	Phase 4	Recruiting	Zhenghui YI

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Lorazepam	Contract Pharmacy Services-PA	67046-924	ORAL	0.5 mg in 1 1	9/14/2017
Ativan	Bausch Health US LLC	0187-0063	ORAL	0.5 mg in 1 1	1/13/2023
Lorazepam	Preferred Pharmaceuticals Inc.	68788-7355	ORAL	0.5 mg in 1 1	7/25/2023
Lorazepam	REMEDYREPACK INC.	70518-0275	ORAL	1 mg in 1 1	1/4/2024
Lorazepam	Amneal Pharmaceuticals LLC	65162-015	ORAL	0.5 mg in 1 1	12/30/2022
Lorazepam	Medsource Pharmaceuticals	45865-499	ORAL	0.5 mg in 1 1	7/20/2018
LORAZEPAM	RedPharm Drug Inc.	67296-0306	ORAL	1 mg in 1 1	5/20/2011
Lorazepam	Contract Pharmacy Services-PA	67046-982	ORAL	2 mg in 1 1	6/26/2008
Lorazepam	Leading Pharma, LLC	69315-905	ORAL	1 mg in 1 1	12/10/2023
Lorazepam	Bryant Ranch Prepack	71335-1467	ORAL	1 mg in 1 1	5/22/2023

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
APO-LORAZEPAM TABLET 1 mg	APOTEX INC	SIN03452P	TABLET	1 mg	6/17/1989
APO-LORAZEPAM TABLET 0.5 mg	APOTEX INC	SIN03708P	TABLET	0.5 mg	10/6/1989
LORANS 1 TABLET 1 mg	MEDOCHEMIE LTD (Factory AZ), MEDOCHEMIE LTD (Central Factory)	SIN00967P	TABLET	1 mg	5/10/1988

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
ATIVAN lorazepam 2.5mg tablet bottle	237802	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/30/2015
Tranqipam 2.5 - South Africa	347657	Aspen Pharma Pty Ltd	Medicine	A	11/9/2020
LORAZE lorazepam 0.5 mg tablet blister pack	304314	Southern XP IP Pty Ltd	Medicine	A	7/22/2019
LORAZE lorazepam 2.5 mg tablet blister pack	304316	Southern XP IP Pty Ltd	Medicine	A	7/22/2019
LORAZEPAM VIATRIS lorazepam 1 mg tablet blister pack	304312	Southern Cross Pharma Pty Ltd	Medicine	A	7/22/2019
ATIVAN Lorazepam 1mg tablet blister pack	10387	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/4/1991
LORAZEPAM SCP lorazepam 0.5 mg tablet blister pack	304308	Southern XP IP Pty Ltd	Medicine	A	7/22/2019
Tranqipam 1 - South Africa	347656	Aspen Pharma Pty Ltd	Medicine	A	11/9/2020
LORAZEPAM-WGR lorazepam 2.5 mg tablet blister pack	439655	Southern Cross Pharma Pty Ltd	Medicine	A	5/6/2024
APO-LORAZEPAM lorazepam 2.5 mg tablet blister pack	304307	Southern Cross Pharma Pty Ltd	Medicine	A	7/22/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ATIVAN	Pfizer Canada Ulc	02041413	Tablet - Oral	0.5 MG	12/31/1994
ATIVAN INJ 4MG/ML	wyeth ltd.	00557773	Liquid - Intramuscular , Intravenous	4 MG / ML	12/31/1982
ATIVAN TAB 2MG	wyeth ltd.	00348333	Tablet - Oral	2 MG / TAB	12/31/1977
LORAZEPAM	sanis health inc	02351072	Tablet - Oral	0.5 MG	6/15/2010
TEVA-LORAZEPAM	teva canada limited	00637742	Tablet - Oral	1 MG	12/31/1985
PRO-LORAZEPAM	PRO DOC LIMITEE	00655651	Tablet - Oral	1 MG	12/31/1986
NU-LORAZ TAB 1MG	nu-pharm inc	00865680	Tablet - Oral	1 MG	12/31/1990
RIVA-LORAZEPAM 2MG TABLETS	laboratoire riva inc.	02240727	Tablet - Oral	2 MG / TAB	8/26/1999
PMS-LORAZEPAM	Pharmascience Inc	00728187	Tablet - Oral	0.5 MG	12/31/1988
ATIVAN	Pfizer Canada Ulc	02041448	Tablet - Oral	2 MG	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LORAZEPAM CINFA 1 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	68477	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
LORAZEPAM NORMON 2 MG COMPRIMIDOS EFG	Laboratorios Normon S.A.	88965	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
LORAZEPAM CINFA 5 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	68478	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
TEMELOR 4 MG/ML SOLUCIÓN INYECTABLE EFG	Medochemie Iberia S.A.	88360	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
DONIX 1 mg	Uxa Farma S.A.	54768	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Not Commercialized
LORAZEPAM NORMON 5 MG COMPRIMIDOS EFG	Laboratorios Normon S.A.	77785	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
LORAZEPAM NORMON 1 MG COMPRIMIDOS EFG	Laboratorios Normon S.A.	64972	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
DONIX 5 mg	Uxa Farma S.A.	55292	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Not Commercialized
ORFIDAL 1 mg COMPRIMIDOS	Pfizer S.L.	49796	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
LORAZEPAM PENSA 1 mg COMPRIMIDOS EFG	Towa Pharmaceutical S.A.	68479	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	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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