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Diazepam

Generic Name
Diazepam
Brand Names
Diastat, Valium, Valtoco 5 Mg Dose Kit
Drug Type
Small Molecule
Chemical Formula
C16H13ClN2O
CAS Number
439-14-5
Unique Ingredient Identifier
Q3JTX2Q7TU

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 .

Background

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

FDA Approved Products

Diazepam
Manufacturer:Natco Pharma USA LLC
Route:INTRAMUSCULAR, INTRAVENOUS
Strength:10 mg in 2 mL
Approved: 2021/10/06
NDC:69339-136
Diazepam
Manufacturer:Mylan Pharmaceuticals Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2017/05/15
NDC:0378-0477
Diazepam
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:5 mg in 1 1
Approved: 2017/05/15
NDC:71335-2239
Diazepam
Manufacturer:Hikma Pharmaceuticals USA Inc.
Route:ORAL
Strength:5 mg in 5 mL
Approved: 2020/05/07
NDC:0054-3188
Diazepam
Manufacturer:Preferred Pharmaceuticals, Inc.
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/05/03
NDC:68788-7452

Singapore Approved Products

DIAPINE INJECTION 5 mg/ml
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:INJECTION
Strength:5 mg/ml
Online:Yes
Approved: 1988/04/27
Approval:SIN00421P
APO-DIAZEPAM TABLET 2 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:2 mg
Online:Yes
Approved: 1988/02/24
Approval:SIN00042P
DIAPINE TABLET 2 mg
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:TABLET
Strength:2 mg
Online:Yes
Approved: 1988/04/27
Approval:SIN00424P
APO-DIAZEPAM TABLET 10 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1988/02/24
Approval:SIN00045P
DIAPINE TABLET 5 mg (yellow)
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:TABLET
Strength:5 mg
Online:Yes
Approved: 1996/09/04
Approval:SIN08909P

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