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Chlordiazepoxide Hydrochloride (CHLORDIAZEPOXIDE)
Chlordiazepoxide Hydrochloride (CHLORDIAZEPOXIDE) is a benzodiazepine medication originally developed by Valeant Pharm Intl and currently owned by the same company. It targets the histamine H1 receptor and is used to treat various conditions including alcohol withdrawal, anxiety, and mixed anxiety and depressive disorder. The medication is a small molecule with a bioavailability of 99% and a half-life of 8.3 hours. CHLORDIAZEPOXIDE is off-patent and has a single generic manufacturer. It is used for a range of indications including general anesthesia and local anesthesia.
At a glance
| Generic name | CHLORDIAZEPOXIDE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Benzodiazepine |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1960 |
Approved indications
- Alcohol withdrawal delirium
- Alcohol withdrawal syndrome
- Anxiety
- Anxiety associated with Menopause
- General anesthesia
- Irritable bowel syndrome
- Local anesthesia
- Mixed anxiety and depressive disorder
- Peptic ulcer
- Pre-Op Apprehension
- Preoperative Anxiety
- Severe anxiety (panic)
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 and PRECAUTIONS, Drug Interactions). The use of benzodiazepines, including chlodiazepoxide hydrochloride, a component of Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP, 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 Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS) . The continued use of benzodiazepines, including Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP, 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 Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP 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 Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP or reduce the dosage (see WARNINGS and DOSAGE AND ADMINISTRATION) .
Common side effects
- Drowsiness
- Ataxia
- Confusion
- Syncope
- Skin eruptions
- Edema
- Minor menstrual irregularities
- Nausea
- Constipation
- Extra pyramidal symptoms
- Increased libido
- Decreased libido
Drug interactions
- clozapine
- ritonavir
- sodium oxybate
Key clinical trials
- Stellate Ganglion Block Versus Oral Medication in Treatment of Palmar Hyperhidrosis (NA)
- Metabolism of Chlordiazepoxide in the Treatment of Alcohol Withdrawal Symptoms
- Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants
- Gabapentin for Alcohol Withdrawal Syndrome (PHASE4)
- Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal (PHASE4)
- Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder (PHASE2,PHASE3)
- A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study (NA)
- Outpatient Treatment of Alcohol Withdrawal Syndrome (PHASE3)
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 |