Diazepam: uses, side effects and safety
Diazepam (Valium) is a benzodiazepine. It is a US Schedule IV controlled substance. It is prescription only (rx) and remains on the US market.
What is Diazepam?
Diazepam is the generic name for Valium, and belongs to the Benzodiazepine class.
| Generic name | diazepam |
|---|---|
| Brand name(s) | Valium |
| Drug class | Benzodiazepine |
| US legal status | US Schedule IV · Prescription only (Rx) |
| Route | Oral |
| Prescription required | Yes |
| Elimination half-life | Terminal elimination half-life up to 48 hours; the active metabolite N-desmethyldiazepam has a terminal elimination half-life up to 100 hours |
| Time to peak concentration | 1-1.5 (range 0.25-2.5) |
| Metabolism | N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and hydroxylated by CYP3A4 to temazepam, which is further metabolized to oxazepam; temazepam and oxazepam are largely eliminated by glucuronidation |
What is Diazepam used for?
Diazepam is approved by the FDA for the following uses. Approval is granted per indication, and a specific product may not be approved for all of them.
- Management of anxiety disorders
- Short-term relief of the symptoms of anxiety
- Symptomatic relief of acute agitation and tremor in acute alcohol withdrawal, including impending or acute delirium tremens and hallucinosis
- Adjunctive relief of skeletal muscle spasm due to reflex spasm to local pathology and spasticity caused by upper motor neuron disorders
- Adjunctive treatment of convulsive disorders
How does Diazepam work?
Most of its anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects are thought to result from facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.
It is metabolised primarily by N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and hydroxylated by CYP3A4 to temazepam, which is further metabolized to oxazepam; temazepam and oxazepam are largely eliminated by glucuronidation.
The elimination half-life is roughly Terminal elimination half-life up to 48 hours; the active metabolite N-desmethyldiazepam has a terminal elimination half-life up to 100 hours. Longer half-lives mean the drug and its active metabolites persist in the body for longer after the last dose.
Common side effects of Diazepam
These are the side effects people report most often. Many diminish after the body adjusts, usually within one to two weeks.
- Drowsiness
- Fatigue
- Muscle weakness
- Ataxia
- Confusion
- Depression
- Dysarthria
- Headache
- Slurred speech
- Tremor
- Vertigo
- Constipation
- Nausea
- Blurred vision
- Diplopia
- Dizziness
- Hypotension
What does Diazepam interact with?
Interactions matter because two safe medicines can become dangerous together. The entries below are the ones most likely to cause harm.
- Opioids (boxed warning: profound sedation, respiratory depression, coma, death)
- Alcohol and other CNS depressants
- CYP3A4 and CYP2C19 inhibitors and inducers alter diazepam and N-desmethyldiazepam exposure
- Fluconazole increases clearance of N-desmethyldiazepam and can shorten the onset of action
Use our drug interaction checker before combining any two prescriptions.
Serious side effects and warning signs
Seek emergency care for any of these
- Boxed warning: concomitant use of benzodiazepines and opioids can cause profound sedation, respiratory depression, coma, and death
- Life-threatening withdrawal reactions including seizures with abrupt discontinuation
- Anterograde amnesia may occur at therapeutic dosages, with risk increasing at higher doses
- Psychiatric and paradoxical reactions: agitation, rage, hallucinations, psychoses, delusions, increased muscle spasticity
- Reports of falls and fractures in benzodiazepine users, with increased risk in the elderly and in those taking concomitant sedatives including alcohol
- Neonatal sedation and withdrawal syndrome with use late in pregnancy
Suspected overdose or a bad reaction should be reported to Poison Control on 1-800-222-1222. That is staffed around the clock and is free.
Legal status of Diazepam
Diazepam is a Schedule IV controlled substance in the United States. That placement is set out in Title 21 of the Code of Federal Regulations, Part 1308, and enforced by the Drug Enforcement Administration. It carries restrictions on prescribing, storage, record-keeping and transfer.
Statutory reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c397a9da-862f-4f3f-8109-7d21691de53a.
Can you get Diazepam without a prescription?
Short answer: no. Diazepam is a prescription medication. Sites advertising it without one are either operating illegally or selling something other than what they claim. We explain the legal routes, the counterfeit problem and how to check a source in detail.
Read the full answer: Diazepam without a prescription →
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Read more →Frequently asked questions
What is Diazepam used for?
Management of anxiety disorders Short-term relief of the symptoms of anxiety Symptomatic relief of acute agitation and tremor in acute alcohol withdrawal, including impending or acute delirium tremens and hallucinosis Adjunctive relief of skeletal muscle spasm due to reflex spasm to local pathology and spasticity caused by upper motor neuron disorders Adjunctive treatment of convulsive disorders
What schedule is Diazepam in the United States?
Diazepam is a Schedule IV controlled substance in the US, listed at 21 CFR Part 1308. Schedule IV means the drug has a defined potential for abuse and is subject to federal record-keeping, storage and prescribing restrictions.
What are the common side effects of Diazepam?
The most frequently reported side effects are drowsiness, fatigue, muscle weakness, ataxia, confusion, depression. Many lessen over the first week or two of treatment.
What should not be combined with Diazepam?
The most clinically important interactions are with opioids (boxed warning: profound sedation, respiratory depression, coma, death), alcohol and other cns depressants, cyp3a4 and cyp2c19 inhibitors and inducers alter diazepam and n-desmethyldiazepam exposure, fluconazole increases clearance of n-desmethyldiazepam and can shorten the onset of action. Always give a pharmacist or prescriber a complete list of everything you take, including over-the-counter drugs and supplements.
Sources & references
Important
This site provides educational information only and does not sell, prescribe or dispense medications. Always consult a licensed healthcare provider. This page is not medical advice.