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
Research Report
A Comprehensive Clinical and Pharmacological Monograph on Diazepam (DB00829)
Section 1: Introduction and Drug Identification
1.1. Overview
Diazepam is a prototypical and historically significant member of the benzodiazepine class of drugs, a group of psychotropic agents renowned for their depressant effects on the central nervous system (CNS). As a long-acting benzodiazepine, it is characterized by a rapid onset of action and a prolonged therapeutic effect, which underpins its diverse clinical utility. Diazepam exhibits a broad spectrum of pharmacological activities, including potent anxiolytic (anxiety-reducing), sedative, skeletal muscle-relaxant, anticonvulsant (anti-seizure), and amnestic (memory-impairing) properties.
First marketed under the iconic brand name Valium, Diazepam has been a cornerstone in the management of a wide array of medical conditions for decades. Its primary indications include the management of anxiety disorders, the symptomatic relief of acute alcohol withdrawal syndrome, the adjunctive treatment of skeletal muscle spasms, and the control of various seizure disorders, including status epilepticus and acute repetitive seizures. Its established efficacy and multifaceted pharmacological profile have secured its place on the World Health Organization's List of Essential Medicines, signifying its importance in global health.
1.2. Chemical and Physical Properties
Chemical Identity
Diazepam is a synthetic small molecule belonging to the 1,4-benzodiazepine class of heterocyclic organic compounds. Its formal chemical name, according to the International Union of Pure and Applied Chemistry (IUPAC), is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one.
Molecular Formula and Weight
The empirical formula for Diazepam is C16H13ClN2O. It has an average molecular weight of approximately 284.74 to 284.75 g/mol and a monoisotopic mass of 284.071640755 Da.
Physical Characteristics
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 1 | Recruiting | |||
2024/03/05 | Phase 3 | Not yet recruiting | |||
2024/02/21 | Early Phase 1 | Completed | Arooj Khan | ||
2024/01/05 | Not Applicable | Completed | |||
2023/10/26 | Phase 3 | Completed | |||
2023/05/24 | Not Applicable | Completed | |||
2023/05/16 | Not Applicable | Not yet recruiting | |||
2022/05/04 | Phase 1 | Withdrawn | |||
2022/03/10 | Phase 4 | Completed | |||
2021/10/13 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 33261-717 | ORAL | 2 mg in 1 1 | 12/27/2013 | |
| N/A | 61919-409 | ORAL | 5 mg in 1 1 | 1/12/2023 | |
| Pharmaceutical Associates, Inc. | 0121-0905 | ORAL | 5 mg in 5 mL | 9/15/2021 | |
| A-S Medication Solutions | 50090-4566 | ORAL | 5 mg in 1 1 | 5/15/2017 | |
| NuCare Pharmaceuticals, Inc. | 68071-3330 | ORAL | 5 mg in 1 1 | 2/12/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-427 | ORAL | 10 mg in 1 1 | 9/2/2020 | |
| A-S Medication Solutions | 50090-3390 | ORAL | 2 mg in 1 1 | 5/15/2017 | |
| Mayne Pharma Commercial LLC | 51862-941 | ORAL | 2 mg in 1 1 | 7/6/2023 | |
| Chartwell RX, LLC | 62135-767 | ORAL | 5 mg in 5 mL | 10/5/2023 | |
| NuCare Pharmaceuticals, Inc. | 68071-3270 | ORAL | 5 mg in 1 1 | 2/11/2021 |
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 |
|---|---|---|---|---|---|
| DIAPINE INJECTION 5 mg/ml | ATLANTIC LABORATORIES CORPN LTD | SIN00421P | INJECTION | 5 mg/ml | 4/27/1988 |
| APO-DIAZEPAM TABLET 2 mg | SIN00042P | TABLET | 2 mg | 2/24/1988 | |
| DIAPINE TABLET 2 mg | ATLANTIC LABORATORIES CORPN LTD | SIN00424P | TABLET | 2 mg | 4/27/1988 |
| APO-DIAZEPAM TABLET 10 mg | SIN00045P | TABLET | 10 mg | 2/24/1988 | |
| DIAPINE TABLET 5 mg (yellow) | ATLANTIC LABORATORIES CORPN LTD | SIN08909P | TABLET | 5 mg | 9/4/1996 |
| DIAZEPAM LIPURO INJECTION 10 mg/2 ml | SIN08242P | INJECTION | 10 mg/2 ml | 7/4/1995 | |
| STESOLID ENEMA 5 mg/2.5 ml | SIN02309P | ENEMA | 5 mg/2.5 ml | 8/30/1988 | |
| APO-DIAZEPAM TABLET 5 mg | SIN00044P | TABLET | 5 mg | 2/24/1988 |
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 |
|---|---|---|---|---|---|
| DIAZEPAM TAB, YELLOW, 5MG | N/A | N/A | N/A | 3/24/1984 | |
| DIAZEPAM TAB 2MG | N/A | N/A | N/A | 3/20/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DIAZEPAM-ARX diazepam 2 mg tablet bottle | 335823 | Medicine | A | 7/2/2020 | |
| DBL DIAZEPAM 10mg/2ml injection ampoule | 115049 | Medicine | A | 3/23/2005 | |
| APO-DIAZEPAM diazepam 2mg tablet blister pack | 134472 | Medicine | A | 11/22/2007 | |
| APO-DIAZEPAM diazepam 5mg tablet blister pack | 134590 | Medicine | A | 11/22/2007 | |
| DIAZEPAM-WGR diazepam 5 mg tablet bottle | 335817 | Medicine | A | 7/2/2020 | |
| APX-DIAZEPAM diazepam 2 mg tablet blister pack | 335816 | Medicine | A | 7/2/2020 | |
| VALPAM 5 diazepam 5 mg tablet bottle | 80812 | Medicine | A | 11/30/2001 | |
| DIAZEPAM-WGR diazepam 2 mg tablet blister pack | 335820 | Medicine | A | 7/2/2020 | |
| VALPAM 2 diazepam 2 mg tablet blister pack | 80809 | Medicine | A | 11/30/2001 | |
| Antenex 10 tablet blister pack | 17603 | Medicine | A | 9/20/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DIAZEPAM 10MG TABLETS | 02232751 | Tablet - Oral | 10 MG / TAB | N/A | |
| BIO-DIAZEPAM | biomed pharma | 02247176 | Tablet - Oral | 10 MG | 4/23/2003 |
| VIVOL | axxess pharma inc. | 00013773 | Tablet - Oral | 10 MG | 12/31/1970 |
| E PAM TAB 10MG | icn canada ltd. | 00272639 | Tablet - Oral | 10 MG | 12/31/1973 |
| BIO-DIAZEPAM | biomed pharma | 02247173 | Tablet - Oral | 2 MG | 4/23/2003 |
| PMS-DIAZEPAM | 02247490 | Tablet - Oral | 2 MG | 12/10/2003 | |
| VALIUM INJ ROCHE 5MG/ML | Hoffmann-La Roche Limited | 00012874 | Liquid - Intravenous
,
Intramuscular | 10 MG / 2 ML | 12/31/1968 |
| MEVAL 2 | medic laboratory ltée | 00276650 | Tablet - Oral | 2 MG / TAB | 12/31/1973 |
| DIASTAT | bausch health, canada inc. | 02519070 | Gel - Rectal | 10 MG / 2 ML | 4/21/2022 |
| DIAZEPAM INJECTION SDZ | 02386143 | Solution - Intramuscular
,
Intravenous | 10 MG / 2 ML | 3/27/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| STESOLID 5 mg solución rectal | 58001 | SOLUCIÓN RECTAL | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| DIAZEPAM CINFA 5 MG COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 80698 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM NORMON 5 mg COMPRIMIDOS | Laboratorios Normon S.A. | 51208 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM CINFA 10 MG COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 80699 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM NORMON 10 MG COMPRIMIDOS EFG | Laboratorios Normon S.A. | 85969 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| TEPAZEPAN 50 MG/5 MG/5 MG CÁPSULAS DURAS | 51519 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| DIAZEPAN PRODES 10 mg COMPRIMIDOS | 39692 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| DIAZEPAM BASI 5 MG/ML SOLUCIÓN INYECTABLE EFG | Laboratorios Basi Industria Farmaceutica S.A. | 89559 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAM NORMOGEN 5 MG COMPRIMIDOS EFG | Laboratorios Normon S.A. | 85979 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| DIAZEPAN PRODES 2 MG/ML SOLUCIÓN ORAL | 41598 | GOTAS ORALES EN SOLUCIÓN | 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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