OXAZEPAM
Oxazepam is a benzodiazepine indicated for the management of anxiety disorders or the short-term relief of anxiety symptoms, including anxiety associated with depression. It is specifically noted for its utility in managing anxiety, tension, agitation, and irritability in older patients. Additionally, it is indicated for use in patients with alcohol withdrawal symptoms, acute tremulousness, or inebriation. The effectiveness of oxazepam for long-term use (exceeding 4 months) has not been systematically evaluated, and physicians should periodically reassess its usefulness for individual patients.
How OXAZEPAM Works
Oxazepam is a short-to-intermediate-acting benzodiazepine that exerts its effects by binding to the benzodiazepine site on the gamma-aminobutyric acid-A (GABA-A) receptor complex in the central nervous system. This binding acts as a positive allosteric modulator, increasing the affinity of the receptor for GABA and increasing the frequency of chloride channel opening. The resulting influx of chloride ions causes neuronal hyperpolarization, leading to an inhibitory effect that manifests as anxiolytic, sedative, and anticonvulsant activity. Unlike many other benzodiazepines, oxazepam is metabolized primarily through glucuronidation (Phase II metabolism), bypassing oxidative pathways in the liver.
Details
- Status
- Prescription
- First Approved
- 1987-01-16
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
Companies
OXAZEPAM Approval History
What OXAZEPAM Treats
4 indicationsOXAZEPAM is approved for 4 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorders
- Anxiety
- Depression
- Alcohol Withdrawal
OXAZEPAM Boxed 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 for use 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 a...
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 for use 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 oxazepam, 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 oxazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see WARNINGS ] . The continued use of benzodiazepines, including oxazepam, 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 oxazepam 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 oxazepam or reduce the dosage [see DOSAGE AND ADMINISTRATION and WARNINGS ].
OXAZEPAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OXAZEPAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXAZEPAM FDA Label Details
Indications & Usage
OXAZEPAM is indicated for the treatment of Anxiety Disorders; Anxiety; Depression; Alcohol Withdrawal.
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 for use in p...
Looking for the branded version?
ZAXOPAM
Full clinical data, patents, trials, and competitive landscape for oxazepam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.