Name: Valium

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What is Valium (diazepam)?

Diazepam is an oral medication that is used to treat anxiety. It belongs to the benzodiazepine family of drugs, the same family that includes:

  • alprazolam (Xanax)
  • clonazepam (Klonopin)
  • lorazepam (Ativan)
  •  flurazepam (Dalmane)

What are the uses for Valium (diazepam)?

  • Diazepam is used for the treatment of disorders with anxiety.
  • Diazepam also is used for the treatment of agitation, tremors, delirium, seizures, and hallucinations resulting from alcohol withdrawal.
  • It is used for the treatment of seizures, relief of muscle spasms in some neurological diseases, and for sedation during surgery.


Mechanism of Action

Modulates postsynaptic effects of GABA-A transmission, resulting in an increase in presynaptic inhibition. Appears to act on part of the limbic system, as well as on the thalamus and hypothalamus, to induce a calming effect


Bioavailability: 90% (PR)

Duration: Variable, dependent on dose and frequency (PO [hypnotic action]); 15-60 min (IV [sedative action])

Peak plasma time: 30-90 min (PO), 5-90 min (PR)

Peak plasma concentration: 373 ng/mL (initial at 45 min); 447 ng/mL (second peak at 70 min)


Protein bound: 98%

Vd: 0.8-1 L/kg


Metabolized by hepatic P450 enzymes CYP2C19, CYP3A4

Metabolites: N-desmethyldiazepam, 3-hydroxdiazepam, oxazepam


Half-life: 20-70 hr (active metabolite)

Renal clearance: 20-30 mL/min

Excretion: Urine

Patient Handout

Print without Office InfoPrint with Office Info


Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Side Effects of Valium

Serious side effects have been reported with Valium. See the “Valium Precautions” section.

Common side effects include:

  • drowsiness
  • fatigue (a feeling of tiredness or exhaustion or a need to rest because of lack of energy or strength)
  • muscle weakness
  • poor coordination (ataxia)
  • dry mouth
  • diarrhea
  • nausea
  • changes in appetite
  • changes in vision

This is not a complete list of Valium side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Valium - Clinical Pharmacology

Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.



After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 – 1.5 hours with a range of 0.25 to 2.5 hours. Absorption is delayed and decreased when administered with a moderate fat meal. In the presence of food mean lag times are approximately 45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours when fasting. This results in an average decrease in Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food.


Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam and its metabolites cross the blood-brain and placental barriers and are also found in breast milk in concentrations approximately one tenth of those in maternal plasma (days 3 to 9 post-partum). In young healthy males, the volume of distribution at steady-state is 0.8 to 1.0 L/kg. The decline in the plasma concentration-time profile after oral administration is biphasic. The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours.


Diazepam is N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyldiazepam and temazepam are both further metabolized to oxazepam. Temazepam and oxazepam are largely eliminated by glucuronidation.


The initial distribution phase is followed by a prolonged terminal elimination phase (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide conjugates. The clearance of diazepam is 20 to 30 mL/min in young adults. Diazepam accumulates upon multiple dosing and there is some evidence that the terminal elimination half-life is slightly prolonged.

Pharmacokinetics in Special Populations


In children 3 - 8 years old the mean half-life of diazepam has been reported to be 18 hours.


In full term infants, elimination half-lives around 30 hours have been reported, with a longer average half-life of 54 hours reported in premature infants of 28 - 34 weeks gestational age and 8 - 81 days post-partum. In both premature and full term infants the active metabolite desmethyldiazepam shows evidence of continued accumulation compared to children. Longer half-lives in infants may be due to incomplete maturation of metabolic pathways.


Elimination half-life increases by approximately 1 hour for each year of age beginning with a half-life of 20 hours at 20 years of age. This appears to be due to an increase in volume of distribution with age and a decrease in clearance. Consequently, the elderly may have lower peak concentrations, and on multiple dosing higher trough concentrations. It will also take longer to reach steady-state. Conflicting information has been published on changes of plasma protein binding in the elderly. Reported changes in free drug may be due to significant decreases in plasma proteins due to causes other than simply aging.

Hepatic Insufficiency

In mild and moderate cirrhosis, average half-life is increased. The average increase has been variously reported from 2-fold to 5-fold, with individual half-lives over 500 hours reported. There is also an increase in volume of distribution, and average clearance decreases by almost half. Mean half-life is also prolonged with hepatic fibrosis to 90 hours (range 66 - 104 hours), with chronic active hepatitis to 60 hours (range 26 - 76 hours), and with acute viral hepatitis to 74 hours (range 49 - 129). In chronic active hepatitis, clearance is decreased by almost half.

Valium Dosage and Administration

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.

Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients,or in the presence of debilitating disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

How is Valium Supplied

For oral administration, Valium is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges. Valium is available as follows: 2 mg, white - bottles of 100 (NDC 0140-0004-01); 5 mg, yellow - bottles of 100 (NDC 0140-0005-01) and 500 (NDC 0140-0005-14); 10 mg, blue - bottles of 100 (NDC 0140-0006-01) and 500 (NDC 0140-0006-14).

Engraved on tablets:

2 mg2 Valium® (front)

ROCHE (twice on scored side)   

5 mg5 Valium® (front)

ROCHE (twice on scored side)   

10 mg10 Valium® (front)

ROCHE (twice on scored side)   


Store at room temperature 59° to 86°F (15° to 30°C). Dispense in tight, light-resistant containers as defined in USP/NF.

Valium is a registered trademark of Hoffmann-La Roche, Inc.

Distributed by:

Roche Laboratories Inc. on behalf of Roche Products Inc.
150 Clove Road
Suite 8
Little Falls, NJ 07424

Revised: June 2017

© 2017 Genentech, Inc. All rights reserved.

Valium (VAL-ee-um)
(diazepam) Tablets, C-IV
      This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: June 2017

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.
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
    • 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.
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
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?"
  • 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
  • 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.
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.
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.
What are the ingredients in Valium?
Active ingredient: diazepam
Inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate
Distributed by: Roche Laboratories Inc. on behalf of Roche Products Inc.
Valium® is a registered trademark of Hoffmann-La Roche, Inc.
For more information, go to or call 1-877-436-3683.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):