Clorazepate

Mechanism-of-action class: GABA A Modulators.

• Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

• Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.contraindicated

For the Symptomatic Relief of Anxiety Clorazepate dipotassium tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient. In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 to 15 mg. Clorazepate dipotassium tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. After the initial dose, the response of the patient may require adjustment of subsequent dosage. Lower doses may be indicated in the elderly patient. Drowsiness may occur at the initiation of treatment and with dosage increment. For the Symptomatic Relief of Acute Alcohol Withdrawal The following dosage schedule is recommended: 1st 24 hours (Day 1) 30 mg initially; followed by 30 to 60 mg in divided doses 2nd 24 hours (Day 2) 45 to 90 mg in divided doses 3rd 24 hours (Day 3) 22.5 to 45 mg in divided doses Day 4 15 to 30 mg in divided doses Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient's condition is stable. The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days. As an Adjunct to Antiepileptic Drugs In order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded. Adults The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day.

Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including clorazepate dipotassium, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe clorazepate dipotassium concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of clorazepate dipotassium than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking clorazepate dipotassium, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when clorazepate dipotassium is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS: Drug Interactions ).

The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech. There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit. Decrease in systolic blood pressure has been observed. To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Dependence and Withdrawal Reactions ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

• Jul 17, 1987ANDAANDA071858Aurobindo Pharma
• Apr 27, 2000ANDAANDA075731Taro
• Jun 14, 2022ANDAANDA215566Corepharma
• Jun 16, 2022ANDAANDA213730Novitium Pharma

1. 1Nausea1357.2%
2. 2Somnolence1286.8%
3. 3Drug Ineffective1256.6%
4. 4Drug Interaction1186.3%
5. 5Off Label Use1045.5%
6. 6Intentional Overdose975.1%
7. 7Suicide Attempt965.1%
8. 8Diarrhoea924.9%
9. 9Fatigue914.8%
10. 10Dizziness894.7%
11. 11Fall884.7%
12. 12Anxiety874.6%
13. 13Headache864.6%
14. 14Toxicity To Various Agents844.5%
15. 15Vomiting824.4%

Recent PubMed references pinned to Clorazepate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Benzodiazepine inhibits anxiogenic-like response in cocaine or ethanol withdrawn planarians.
  Behavioural pharmacology · 2016 · Nayak S, Roberts A, Bires K, et al.
  PMID 27028903DOI 10.1097/FBP.0000000000000236
• The author responds.
  Journal of the American Veterinary Medical Association · 2015 · Irimajiri M
  PMID 25654819
• Questions ethics of crating.
  Journal of the American Veterinary Medical Association · 2015 · Fox MW
  PMID 25517322DOI 10.2460/javma.246.1.49
• Animal behavior case of the month. Separation anxiety.
  Journal of the American Veterinary Medical Association · 2014 · Irimajiri M, Crowell-Davis SL
  PMID 25313810DOI 10.2460/javma.245.9.1007
• [Physical compatibility of a mixture of alizapride and clorazepate in flexible infusion bags of 100 ml of 5% glucose].
  Journal de pharmacie de Belgique · 2014 · Anrys P, Magnette A, Jamart J, et al.
  PMID 25226762
• Benzodiazepines increase the reward effects of buprenorphine in a conditioned place preference test in the mouse.
  Fundamental & clinical pharmacology · 2014 · Ma LL, Freret T, Lange M, et al.
  PMID 24617653DOI 10.1111/fcp.12072
• Fluoxetine combined with clorazepate dipotassium and behaviour modification for treatment of anxiety-related disorders in dogs.
  Veterinary journal (London, England : 1997) · 2014 · Pineda S, Anzola B, Olivares A, et al.
  PMID 24439470DOI 10.1016/j.tvjl.2013.11.021
• Differential behavioral profile induced by the injection of dipotassium chlorazepate within brain areas that project to the nucleus accumbens septi.
  Pharmacological reports : PR · 2013 · Llano López LH, Caif F, Fraile M, et al.
  PMID 23950579DOI 10.1016/s1734-1140(13)71034-x

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Clorazepate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
  Terminated · Phase 3 · Interventional · 323 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04726592updated 2025-09-08
• Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
  Terminated · Phase 4 · Interventional · 100 enrolled · Polish Lymphoma Research Group
  NCT02323659updated 2022-01-13
• Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
  Terminated · Phase 4 · Interventional · 104 enrolled · Hospital Universitari de Bellvitge
  NCT01305707updated 2015-08-31
• Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions
  Completed · Interventional · 32 enrolled · Ranbaxy Laboratories Limited
  NCT00775996updated 2008-10-20

Frequently asked questions

How does Clorazepate work?

Mechanism-of-action class: GABA A Modulators.

What is Clorazepate used for?

According to FDA labeling, Clorazepate carries indications including: Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clorazepate?

Clorazepate is classified as GABA A Modulators, Increased Central Nervous System GABA Activity.

What are the brand names for Clorazepate?

Clorazepate is marketed under brand names including Tranxene.

What are the contraindications for Clorazepate?

Clorazepate labeling lists contraindications including: Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.. Always consult the full prescribing information and a clinician.