Indicated for:

Anxiety:

• 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.

Acute Alcohol Withdrawal:

• In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinations.

Skeletal Muscle Spasms and Spasticity:

• Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.

Convulsive Disorders:

• Oral Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

The effectiveness of Valium in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

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.

Valium is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.

Psychiatric and paradoxical reactions are known to occur when using benzodiazepines.

A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.

Some loss of response to the effects of benzodiazepines may develop after repeated use of Valium for a prolonged time.

The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression or anxiety associated with depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

The continued use of benzodiazepines, including VALIUM, 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 VALIUM 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 VALIUM or reduce the dosage.

In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.

Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. Once physical dependence to benzodiazepines has developed, termination of treatment will be accompanied by withdrawal symptoms. The risk is more pronounced in patients on long-term therapy.

The use of benzodiazepines, including VALIUM, 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  increased frequency of serious adverse outcomes. Before prescribing VALIUM and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

Extensive accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted following chronic administration of diazepam in healthy elderly male subjects. Metabolites of this drug are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.

Valium is contraindicated in patients:

• under 6 months of age
• with myasthenia gravis
• with severe respiratory insufficiency
• with severe hepatic insufficiency
• with sleep apnea syndrome
• with acute narrow-angle glaucoma. It may be used in patients with open-angle glaucoma who are receiving appropriate therapy

Since Valium has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during Valium therapy.

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.

There is a potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.

If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants.

The metabolic elimination of phenytoin is decreased by diazepam.

An increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy.

Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving Valium.

GoToSource

• Use in patients under 6 months of age. GoToSource

• Insomnia. GoToSource

• Vertigo. GoToSource

• Urogenital pain/pelvic floor dysfunction. GoToSource

• Relief of catatonia in mood disorder. GoToSource

• Nocturnal enuresis. GoToSource

• Tinnitus. GoToSource

• Gamma-butyrolactone dependence and withdrawal. GoToSource

• Restless legs syndrome and pre/post-operative sedation. GoToSource

• AIDS dementia. GoToSource

⚠️  Patients with CYP2C19 and CYP3A4 gene variations could lead to increased and prolonged sedation.

Dependence and withdrawal syndrome. GoToSource

Respiratory depression and arrest. GoToSource

Increased risk of mortality from community-acquired pneumonia. GoToSource

Hypoventilation at high altitude. GoToSource

Aggression. GoToSource

Seizures, amnesia, ataxia, confusion, sedation and tachycardia. GoToSource

Suicidality, hypotension, paradoxical CNS stimulation and fetal harm. GoToSource

Cognitive impairment. GoToSource

Acute closed-angle glaucoma. GoToSource

Lawsuits filed for addiction and brain damage.