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
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 |
|---|---|---|---|---|---|
| Diazepam Injection | 国药准字H61022214 | 化学药品 | 注射剂 | 12/11/2020 | |
| Diazepam Injection | 国药准字H41020631 | 化学药品 | 注射剂 | 12/9/2019 | |
| Diazepam Injection | 国药准字H44022534 | 化学药品 | 注射剂 | 3/3/2020 | |
| Diazepam Injection | 国药准字H51020677 | 化学药品 | 注射剂(注射液) | 6/23/2021 | |
| Diazepam Injection | 国药准字H32021576 | 化学药品 | 注射剂(注射液) | 12/17/2020 | |
| Diazepam Injection | 国药准字H12020957 | 化学药品 | 注射剂 | 7/27/2020 | |
| Diazepam Injection | 国药准字H14021957 | 化学药品 | 注射剂 | 4/20/2020 | |
| Diazepam Injection | 国药准字H32021652 | 化学药品 | 注射剂 | 3/25/2021 | |
| Diazepam Injection | 国药准字H37022949 | 化学药品 | 注射剂 | 8/11/2023 | |
| Diazepam Injection | 国药准字H14022662 | 化学药品 | 注射剂 | 4/10/2020 |
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 |
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