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Valium (diazepam)
Diazepam is a benzodiazepine indicated for anxiety disorders, acute alcohol withdrawal, skeletal muscle spasm, and adjunctive use in convulsive disorders. It is highly protein-bound with a long terminal elimination half-life up to 48 hours and active metabolites persisting up to 100 hours, requiring careful monitoring with repeated dosing. Significant contraindications include myasthenia gravis, severe respiratory insufficiency, and acute narrow-angle glaucoma; concomitant use with opioids carries high risk of respiratory depression. Long-term efficacy beyond 4 months has not been established, and periodic reassessment of usefulness is recommended.
At a glance
| Generic name | diazepam |
|---|---|
| Also known as | Valium, Diastat |
| Sponsor | Generic (originally Roche) |
| Drug class | Benzodiazepine [EPC] |
| Target | Adenosine receptor A3, Aldo-keto reductase family 1 member C1, Aldo-keto reductase family 1 member C2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1963-11-15 (United States) |
Approved indications
- Alcohol withdrawal delirium
- Alcohol withdrawal syndrome
- Anxiety
- Epilepsy
- Induce Anterograde Amnesia
- Preoperative Anxiety
- Sedation
- Spasticity
- Status epilepticus
- Tetanus
Boxed warnings
- WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). • The use of benzodiazepines, including diazepam tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing diazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ) . • The continued use of benzodiazepines, including diazepam tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ) .
Common side effects
- Drowsy
- Constipation
- Loopy
- Nausea
- Upset Stomach
- Diarrhea
Drug interactions
- Opioids
- Centrally acting agents (phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, barbiturates, MAO inhibitors, antidepressants)
- Alcohol
- Antacids
- Hepatic enzyme inhibitors (CYP3A4 and 2C19 inhibitors: cimetidine, ketoconazole)
Key clinical trials
- Comparison of The Effectiveness Between Conventional Therapy and Conventional Therapy Plus Pulsed-Radiofrequency in Herniated Nucleus Pulposus Patients at Dr. Saiful Anwar Hospital, Malang (NA)
- Effects of Clonidine Added to Lidocaine in Sub-Tenon's and Peribulbar Anesthesia: Assessments of Intraocular Pressure (IOP), Ocular Perfusion Pressure (OPP) and Ocular Pulse Amplitude (OPA) (Phase 2)
- The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients (NA)
- Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study (Phase 4)
- Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial (NA)
- Remote Treatment of Alcohol Withdrawal: A Pilot Study (NA)
- Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs (NA)
- Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care (Phase 4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12324852 | 2032-10-16 | Method of Use |
| 12337061 | 2032-06-13 | Method of Use |
| 12268664 | 2029-03-27 | Formulation |
| 12521400 | 2029-03-27 | Formulation |
| 11793786 | 2029-03-27 | Formulation |
| 8895546 | 2029-03-27 | Formulation |
| 11241414 | 2029-03-27 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |