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Clorazepate (Tranxene) is a long-acting benzodiazepine medication primarily prescribed for anxiety disorders, as adjunctive treatment of partial seizures, and in the management of alcohol withdrawal symptoms. [1] It enhances the effect of the inhibitory neurotransmitter GABA in the brain, producing anti-anxiety and anti-seizure effects. [2]
Because of its relatively long half-life (~2 days), clorazepate can build up in the body and carries a risk of sedation and dependence. [1] It is classified as a Schedule IV controlled substance in the United States. [3]
| Category | Clorazepate (clorazepate dipotassium) |
|---|---|
| Class | Benzodiazepine (anxiolytic/anticonvulsant) |
| Brand name | Tranxene |
| Half-life | ~48 hours (active metabolite) |
| Controlled substance status | Schedule IV (C-IV) |
- Clorazepate (Tranxene) is prescribed for short-term relief of anxiety symptoms, as an adjunct therapy for partial seizures, and for managing acute alcohol withdrawal symptoms.
- Clorazepate is an inactive prodrug that converts to nordiazepam (desmethyldiazepam) in the stomach; the active metabolite then binds to GABA-A receptors, leading to sedation and reduced anxiety.
- Clorazepate has a very long elimination half-life (~40–50 hours) and is a Schedule IV controlled drug, reflecting its potential for dependence and withdrawal if it is not used as indicated.
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What is clorazepate (Tranxene)?
Clorazepate (Tranxene) is a prescription benzodiazepine tranquilizer with anxiolytic (anti-anxiety), sedative, anticonvulsant, and muscle relaxant properties. [4] In U.S. practice, it is mainly indicated for the management of anxiety disorders, for use as add-on treatment in treating partial seizures (epilepsy), and for the symptomatic relief of acute alcohol withdrawal. [1]
It is not meant for everyday stress or mild anxiety; instead, it is used to treat more significant anxiety or specific conditions (like epilepsy or alcohol withdrawal) where its benefits outweigh risks. The effectiveness of Tranxene for anxiety is best established for a maximum of 4 months of use, so periodic reassessment is recommended if long-term treatment is considered. [1]
How clorazepate works: Mechanism of action
Clorazepate itself isn't active in your body. Once you swallow it, your stomach acid converts it into an active form or metabolite called nordiazepam. This conversion involves removing part of the original molecule, which is a process that also releases carbon dioxide. [1][2]
Nordiazepam then enters your bloodstream, where it stays active for around two days (40–50 hours). Like other benzodiazepines, nordiazepam boosts the effects of GABA, which slows down nerve activity. This leads to feelings of calmness and lowered anxiety and can help control seizures. [1][2]
Dosage and administration guidelines
Clorazepate is available as oral tablets (Tranxene T-Tabs) in strengths of 3.75 mg, 7.5 mg, and 15 mg. [1] Dosing is individualized based on the condition being treated and specific patient factors, such as age and response. Below are general guidelines:
- Dosage for anxiety: A typical adult dose for anxiety is 30 mg per day in divided doses. This may be adjusted between 15 mg and 60 mg daily, depending on the response. Elderly patients usually start at lower doses (7.5–15 mg per day) due to increased sensitivity to sedation. [1]
- Dosage for seizures: When used alongside other anticonvulsants for partial seizures, adults and adolescents (older than 12 years) usually start at 7.5 mg three times daily, with gradual weekly increases of 7.5 mg if needed. The typical maintenance dose should not exceed a maximum of about 90 mg per day in adults. [2]
- Dosage for alcohol withdrawal: For acute alcohol withdrawal, higher doses of clorazepate are used short-term under medical supervision. The dose should be tapered down gradually over 3–5 days to help prevent severe withdrawal symptoms. [3]
Clorazepate (Tranxene) tablets must be swallowed whole (they should not be crushed or chewed). Taking Tranxene with a light meal can reduce the risk of stomach upset. If you've been taking benzodiazepines (like clorazepate) for anxiety, seizures, or alcohol withdrawal for more than two weeks, avoid stopping them suddenly, as this may cause severe withdrawal symptoms. Instead, always taper your Tranxene dosage gradually under medical supervision to safely manage benzodiazepine dependence. [3]
Clorazepate side effects and risks
Clorazepate’s side effects are similar to those of other benzodiazepines and primarily relate to CNS depression. The most frequently reported side effects are: [1]
- Drowsiness
- Somnolence
- Fatigue
- Lightheadedness
- Dizziness
- Coordination problems (like an unsteady gait or ataxia)
- Blurred vision
- Dry mouth
- Mild nausea or constipation
- Headache
Clorazepate can also affect mood and cognition, causing: [1]
- Confusion
- Impaired memory
- Irritability
Paradoxical reactions (such as agitation, heightened anxiety, or insomnia) are rare but have been observed with benzodiazepine use in susceptible individuals. If any unusual paradoxical response occurs, the medication should be re-evaluated by a doctor. Serious risks primarily involve excessive sedation and respiratory depression. [4]
Precautions and contraindications
Clorazepate is not safe for everyone, and several precautions must be taken before and during use.
Medical conditions
- Allergies and glaucoma: Do not use clorazepate if you are allergic to it or any other benzodiazepines. It is also contraindicated in people with acute narrow-angle glaucoma. [1]
- Mental health conditions: Clorazepate should not be used to treat severe depression or psychosis, as it is generally ineffective for these conditions and may worsen mood symptoms or increase impulsivity. [1]
- Liver or kidney impairment: People with liver or kidney conditions may metabolize clorazepate more slowly, increasing the risk of side effects. [1]
Age-related risks
Functional and lifestyle considerations
- Driving and machinery use: Avoid driving or performing hazardous tasks until you know how clorazepate affects you. Sedation associated with clorazepate can impair coordination, reflexes, and judgment. [1]
- Use of alcohol and CNS depressants: Avoid alcohol and other CNS depressants while taking clorazepate, unless a doctor explicitly allows it. Combining substances can amplify sedation and impair alertness. [1]
Reproductive considerations
- Pregnancy risks: Clorazepate is not recommended during pregnancy unless no safer alternative is available. Benzodiazepines have been associated with risks to the neonate, such as sedation, withdrawal symptoms, and breathing issues. [5] If clorazepate is medically necessary (e.g., for epilepsy), it should be used at the lowest effective dose and only under medical supervision.
- Breastfeeding: Do not breastfeed while taking clorazepate. Its active form, nordiazepam, passes into breast milk and may cause excessive sleepiness, poor feeding, or breathing problems in infants. [1]
Dependence and withdrawal
Prolonged use of clorazepate can lead to physical dependence, meaning the body adapts to its presence. If the medication is suddenly stopped, a benzodiazepine withdrawal syndrome can occur. [1]
Withdrawal symptoms may include: [3]
- Anxiety
- Insomnia
- Restlessness
- Irritability
- Tremors
- Sweating
- In severe cases, seizures or delirium
To minimize these risks, clorazepate should never be stopped “cold turkey” if it has been used for more than a short period of time. Doctors will implement a gradual tapering schedule to wean patients off safely [3], sometimes over weeks or months, depending on the dose and duration of use.
Beyond physical dependence, there is a risk of psychological dependence and habituation. Some people may begin to feel they cannot cope without clorazepate or may crave its sedative effects. With time, tolerance may develop to clorazepate’s sedative or euphoric effects, requiring higher doses for the same relief. Anti-anxiety effects tend to remain more stable. For this reason, clorazepate is usually prescribed short-term, with a plan to taper once it’s no longer necessary.
Can clorazepate cause addiction?
Clorazepate has the potential for abuse and addiction, especially if not taken as directed. It is a Schedule IV controlled substance because of its recognized abuse potential. [3]
Even when used at prescribed dosages, some patients (particularly those with a history of substance misuse) may have a higher risk of clorazepate misuse. The FDA warns that using benzodiazepines, including clorazepate, can expose people who take clorazepate to risks of misuse, abuse, and addiction—even if the medication is taken as instructed. [1] If there is concern about addiction, consult a healthcare professional immediately.
Is clorazepate a controlled substance?
Yes, in the United States, clorazepate is regulated as a Schedule IV controlled substance. [3] This designation means it is legal only with a prescription, and it has a lower (but still significant) potential for abuse and dependence relative to Schedule II or III drugs.
All benzodiazepines are Schedule IV controlled substances. For patients, this classification means that prescription refills are limited, and prescriptions will be carefully monitored.
Patient tips for safe use
If you are prescribed clorazepate, consider the following tips to use it safely and effectively:
- Take exactly as prescribed. Use clorazepate only at the dose and frequency your doctor recommends. Do not take more pills or take them more often, even if you feel anxious. Do not suddenly change your dose or stop the medication on your own. Always consult your healthcare provider for adjustments.
- Avoid using alcohol and other sedatives along with it. While on clorazepate, it is best not to drink alcohol or use other sedative drugs (such as opioids or sleep medications) unless your doctor explicitly says it is necessary. [3] Combining these substances can cause dangerously deep sedation or breathing problems.
- Use caution with certain activities. Until you know how clorazepate affects you, do not drive, operate heavy machinery, or do anything requiring decision-making or alertness. [1]
- Do not stop clorazepate abruptly. If you have taken clorazepate for more than a couple of weeks, don’t discontinue it suddenly. Stopping too quickly can trigger withdrawal symptoms, like anxiety, tremors, or seizures. [3]
- Store clorazepate securely and don’t share it. Keep clorazepate in a secure place, out of reach of others (for instance, in a locked cabinet). This medication has abuse potential, so it should never be taken by anyone other than the person for whom it was prescribed. Do not share your clorazepate with friends or family, even if they have similar symptoms. Not only is this unsafe, but it’s also against the law. Dispose of any unused tablets properly to prevent misuse (pharmacists can advise on drug take-back programs).
By following these precautions, you can reduce the risks associated with clorazepate and use it more safely. Always maintain open communication with your healthcare provider. Report any unusual side effects or concerns promptly. With responsible use and medical supervision, clorazepate can be an effective medication for the short-term relief of anxiety, control of seizures, or reduction in alcohol withdrawal symptoms, all while still minimizing potential medication-associated harms.
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