Overview
A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of gamma-aminobutyric acid activity. It is used in the treatment of severe anxiety disorders, as a hypnotic in the short-term management of insomnia, as a sedative and premedicant, as an anticonvulsant, and in the management of alcohol withdrawal syndrome. (From Martindale, The Extra Pharmacopoeia, 30th ed, p589) Given diazepam's storied history as a commonly used and effective medication for a variety of indications, contemporary advancements in the formulation and administration of the agent include the development and US FDA approval of an auto-injectable formulation for the rapid treatment of uncontrolled seizures in 2015-2016 . Combining diazepam, a proven effective therapy for acute repetitive seizures, with an auto-injector designed for subcutaneous administration that is quickly and easily administered offers the potential for complete, consistent drug absorption and rapid onset of effect . This current development is subsequently an important addition to the rescue therapy tool chest for patients with epilepsy .
Indication
In general, diazepam is useful in the symptomatic management of mild to moderate degrees of anxiety in conditions dominated by tension, excitation, agitation, fear, or aggressiveness such as may occur in psychoneurosis, anxiety reactions due to stress conditions, and anxiety states with somatic expression. Moreover, in acute alcoholic withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, and impending acute delirium tremens. Furthermore, diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathologies, such as inflammation of the muscle and joints or secondary to trauma; spasticity caused by upper motor neuron disorders, such as cerebral palsy and paraplegia; athetosis and the rare "stiff man syndrome". Particular label information from the United Kingdom also lists particular age-specific indications, including for adults: (1) The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness, (2) cerebral palsy, (3) muscle spasm, (4) as an adjunct to certain types of epilepsy (eg. myoclonus), (5) symptomatic treatment of acute alcohol withdrawal, (6) as oral premedication for the nervous dental patient, and (7) for premedication before surgery. In the same UK label information, diazepam is indicated in children for: (1) control of tension and irritability in cerebral spasticity in selected cases, (2) as an adjunct to the control of muscle spasm in tetanus, and for (3) oral premedication. A diazepam nasal spray is indicated in patients 6 years and older to treat intermittent, stereotypic episodes of frequent seizure activity that are different than the patient's usual seizure pattern.
Associated Conditions
- Acute Agitation
- Alcohol Withdrawal Delirium
- Alcohol Withdrawal Hallucinosis
- Anxiety
- Anxiety Disorders
- Apprehension
- Refractory Epilepsy
- Skeletal Muscle Spasms
- Status Epilepticus
- Stress (Psychology)
- Tension
- Tremor
- Convulsive disorders
- Intermittent distinct from a patient’s usual seizure pattern, stereotypic episode Epileptic seizure
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/10/06 | Early Phase 1 | Completed | University of Brasilia | ||
2021/09/13 | Phase 4 | Completed | Edin Mešanović | ||
2021/05/13 | Phase 4 | UNKNOWN | |||
2021/04/26 | Not Applicable | Completed | |||
2020/09/30 | Phase 4 | Completed | |||
2020/04/28 | Not Applicable | UNKNOWN | |||
2020/01/03 | Phase 4 | Withdrawn | |||
2019/12/13 | Phase 4 | UNKNOWN | |||
2019/06/25 | Not Applicable | Completed | |||
2019/05/17 | Phase 1 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional Inc. | 51079-285 | ORAL | 5 mg in 1 1 | 2/8/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-783 | ORAL | 5 mg in 1 1 | 4/9/2014 | |
| RedPharm Drug, Inc. | 67296-0084 | ORAL | 5 mg in 1 1 | 8/18/2022 | |
| Contract Pharmacy Services-PA | 67046-947 | ORAL | 10 mg in 1 1 | 12/29/2018 | |
| REMEDYREPACK INC. | 70518-2358 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 2 mL | 2/28/2024 | |
| Physicians Total Care, Inc. | 54868-0617 | INTRAMUSCULAR, INTRAVENOUS | 5 mg in 1 mL | 4/3/2012 | |
| Apotheca, Inc. | 12634-529 | ORAL | 5 mg in 1 1 | 3/12/2010 | |
| Bryant Ranch Prepack | 63629-2948 | ORAL | 2 mg in 1 1 | 10/2/2023 | |
| Contract Pharmacy Services-PA | 67046-945 | ORAL | 2 mg in 1 1 | 9/21/2017 | |
| STAT RX USA LLC | 16590-070 | ORAL | 5 mg in 1 1 | 2/22/2010 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VALIUM diazepam 5 mg tablet blister pack | 48566 | Medicine | A | 5/17/1994 | |
| DIAZEPAM-ARX diazepam 5 mg tablet bottle | 335821 | Medicine | A | 7/2/2020 | |
| DIAZEPAM-WGR diazepam 2 mg tablet bottle | 335819 | Medicine | A | 7/2/2020 | |
| Antenex 10 tablet bottle | 17581 | Medicine | A | 9/20/1991 | |
| RANZEPAM diazepam 5mg tablet blister pack | 134473 | Medicine | A | 11/22/2007 | |
| VALPAM 2 diazepam 2 mg tablet bottle | 80810 | Medicine | A | 11/30/2001 | |
| NOUMED DIAZEPAM diazepam 5 mg tablet blister pack | 324680 | Medicine | A | 12/13/2019 | |
| APX-DIAZEPAM diazepam 5 mg tablet bottle | 335813 | Medicine | A | 7/2/2020 | |
| APX-DIAZEPAM diazepam 2 mg tablet bottle | 335815 | Medicine | A | 7/2/2020 | |
| APX-DIAZEPAM diazepam 5 mg tablet blister pack | 335814 | Medicine | A | 7/2/2020 |
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NOVO-DIPAM TAB 5MG | novopharm limited | 00272442 | Tablet - Oral | 5 MG | 12/31/1973 |
| DIAZEPAM INJECTION USP | 00399728 | Solution - Intravenous
,
Intramuscular | 5 MG / ML | 12/31/1980 | |
| DIAZEPAM 10TAB 10MG | PRO DOC LIMITEE | 00434388 | Tablet - Oral | 10 MG | 12/31/1978 |
| NOVO-DIPAM TAB 2MG | novopharm limited | 00272434 | Tablet - Oral | 2 MG | 12/31/1973 |
| DIAZEPAM AUTOINJECTOR | meridian medical technologies inc. | 02243240 | Liquid - Intramuscular | 10 MG / 2 ML | 1/24/2007 |
| DIAZEPAM | aa pharma inc | 00405337 | Tablet - Oral | 10 MG | 12/31/1979 |
| DIAZEPAM INJECTION USP | hikma canada limited | 02385392 | Solution - Intravenous
,
Intramuscular | 5 MG / ML | 3/16/2017 |
| PMS-DIAZEPAM SOLUTION 1MG/ML | 00891797 | Solution - Oral | 1 MG / ML | 12/31/1992 | |
| NOVO-DIPAM TAB 10MG | novopharm limited | 00272450 | Tablet - Oral | 10 MG | 12/31/1973 |
| DIASTAT | bausch health, canada inc. | 02238162 | Gel - Rectal | 5 MG / 1 ML | 1/28/2000 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ANEUROL 5 mg/10 mg COMPRIMIDOS RECUBIERTOS | Lacer S.A. | 39501 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| DIAZEPAN PRODES 2,5 mg COMPRIMIDOS | 42003 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| DIAZEPAM AUROVITAS SPAIN 10 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 81515 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM ARISTO 10 MG COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 86114 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| VALIUM 10 mg /2 ml SOLUCION INYECTABLE | Atnahs Pharma Netherlands Bv. | 39943 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| ANSIUM CAPSULAS DURAS | Neuraxpharm Spain S.L. | 53295 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAN PRODES 25 mg COMPRIMIDOS | 48242 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| DIAZEPAM DURBAN 10 MG COMPRIMIDOS EFG | Laboratorios Francisco Durban S.A. | 82872 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| VALIUM 10 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 39905 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM AUROVITAS 2,5 MG COMPRIMIDOS | Aurovitas Spain, S.A.U. | 89721 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.