Valium

Generic name: diazepam (oral)
Drug classes: Benzodiazepine anticonvulsants, Benzodiazepines

Medically reviewed by  A Ras MD.

What is Valium?

Valium is a prescription medicine used to treat anxiety disorders, for the short-term relief of the symptoms of anxiety, to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), sudden and severe mental or nervous system changes (delirium tremens) and seeing or hearing things that others do not see or hear (hallucinations), along with other medicines for the relief of muscle spasms and  along with other medicines to treat seizure disorders.

Valium is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep Valium in a safe place to prevent misuse and abuse. Selling or giving away Valium may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

It is not known if Valium is safe and effective in children under 6 months of age.

It is not known if Valium is safe and effective for use longer than 4 months.

Description

Valium (diazepam) is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows:

Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain no dye.

What is the most important information I should know about Valium?

• Valium is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
• Valium can make you sleepy or dizzy, and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Valium affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Valium without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Valium may make your sleepiness or dizziness much worse.
• Do not take more Valium than prescribed.

Who should not take Valium?

Do not take Valium if you:

• are allergic to diazepam or any of the ingredients in Valium. See the end of this Medication Guide for a complete list of ingredients in Valium.
• have a disease that can cause muscle weakness called myasthenia gravis
• have severe breathing problems (severe respiratory insufficiency)
• have severe liver problems
• have a sleep problem called sleep apnea syndrome

What should I tell my healthcare provider before taking Valium?

Before you take Valium, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have lung disease or breathing problems
• have liver or kidney problems
• are pregnant or plan to become pregnant. Valium may harm your unborn baby. You and your healthcare provider should decide if you should take Valium while you are pregnant.
• are breastfeeding or plan to breastfeed. Valium passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Valium. Do not breastfeed while taking Valium.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Valium with certain other medicines can cause side effects or affect how well Valium or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take Valium?

• Take Valium exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Valium to take and when to take it.
• Talk to your healthcare provider about slowly stopping Valium to avoid withdrawal symptoms.
• If you take too much Valium, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Valium?

• Valium can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how Valium affects you.
• You should not drink alcohol while taking Valium. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Valium?

Valium may cause serious side effects, including:

• See “What is the most important information I should know about Valium?” above.
• Seizures. Taking Valium with other medicines used to treat epilepsy can cause an increase in the number or severity of grand mal seizures.
• Withdrawal symptoms. You may have withdrawal symptoms if you stop taking Valium suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping Valium to avoid withdrawal symptoms.
• Like other antiepileptic drugs, Valium may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
    • thoughts about suicide or dying
    • new or worse anxiety
    • trouble sleeping (insomnia)
    • acting on dangerous impulses
    • attempts to commit suicide
    • feeling agitated or restless
    • new or worse irritability
    • an extreme increase in activity and talking (mania)
    • new or worse depression
    • panic attacks
    • fast heart rate
    • acting aggressive, being angry, or violent
    • other unusual changes in behavior or mood
  • How can I watch for early symptoms of suicidal thoughts and actions?
    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
• Abuse and dependence. Taking Valium can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

The most common side effects of Valium include:

• drowsiness
• muscle weakness
• fatigue
• loss of control of body movements (ataxia)

These are not all the possible side effects of Valium. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

General information about the safe and effective use of Valium

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Valium for a condition for which it was not prescribed. Do not give Valium to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Valium that is written for health professionals.

How should I store Valium?

• Store Valium in a tightly closed container between 68°F to 77°F (20°C to 25°C) and out of the light.
• Keep Valium and all medicines out of the reach of children.

What are the ingredients in Valium?

Active ingredient: diazepam

Inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate

Label

PRINCIPAL DISPLAY PANEL – 2 MG TABLET BOTTLE LABEL

• NDC 0140-0004-01
• Valium®
  (diazepam)
• CIV
• 2 mg
• Each tablet contains 2 mg diazepam.
• Rx only
• 100 tablets
• Roche
• 10185528

PRINCIPAL DISPLAY PANEL – 5 MG TABLET BOTTLE LABEL

• NDC 0140-0005-01
• Valium®
  (diazepam)
• CIV
• 5 mg
• Each tablet contains 5 mg diazepam.
• Rx only
• 100 tablets
• Roche
• 10185529

PRINCIPAL DISPLAY PANEL – 10 MG TABLET BOTTLE LABEL

• NDC 0140-0006-01
• Valium®
  (diazepam)
• CIV
• 10 mg
• Each tablet contains 10 mg diazepam.
• Rx only
• 100 tablets
• Roche
• 10185530

SRC: NLM .