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Description

Generic Name

Diazepam

Active Ingredient

Diazepam

Chemical Name and Composition

Diazepam is chemically described as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one.

Diazepam is a colorless to light yellow crystalline compound. It is practically insoluble in water and soluble in alcohol. It has a molecular weight of about 284.75.

Medication Classification

Valium is a benzodiazepine. It works by enhancing the activity of gamma-aminobutyric acid (GABA), a natural chemical in the brain that calms nerve activity. This calming effect helps reduce anxiety, relax muscles, and control certain types of seizures.

Valium is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indications

Valium is indicated for:

• Anxiety disorders and the short-term relief of anxiety symptoms
• Acute alcohol withdrawal, to help relieve symptoms such as agitation, tremor, and impending or acute delirium tremens
• Skeletal muscle spasm caused by local injury, inflammation, or certain neurological conditions, and spasticity from upper motor neuron disorders
• Seizure disorders, as an add-on (adjunctive) treatment
• The rectal gel is indicated for the management of certain patients with epilepsy who have episodes of increased seizure activity (acute repetitive seizures or seizure clusters)

Valium may also be used before certain medical procedures to relieve anxiety, as directed by a provider.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Oral tablets
  • Injectable solution (for intramuscular or intravenous use by a healthcare provider)
  • Rectal gel
• Route of Administration: Oral, injection (given by a provider), or rectal
• Common Strengths:
• • Oral tablets: 2 mg, 5 mg, and 10 mg
  • Injectable solution: 5 mg per mL
  • Rectal gel: 2.5 mg, 10 mg, and 20 mg delivery systems

Formulations and strengths may vary by manufacturer. Confirm the exact strength on your product label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Oral tablets may contain anhydrous lactose, corn starch, calcium stearate, microcrystalline cellulose, and colorants that differ by tablet strength. The injectable solution may contain propylene glycol, ethanol, sodium benzoate, benzoic acid, and benzyl alcohol. The rectal gel may contain propylene glycol, ethyl alcohol, hydroxypropyl methylcellulose, sodium benzoate, benzoic acid, and benzyl alcohol. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Valium exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your condition, your age, and your overall health. Do not change your dose or stop taking it without medical guidance.

How to Take Valium

• Oral tablets: Swallow with water. Valium is usually taken one to several times a day, depending on your condition and your provider's directions.
• Injectable solution: A healthcare provider gives this form in a clinical setting by injection into a muscle or vein.
• Rectal gel: This form is used at home to treat seizure clusters. A caregiver should be trained by the provider on how and when to give it. Follow the step-by-step instructions provided with the product exactly.
• Do not take more than prescribed, and do not take it more often than directed.

Food Considerations

Valium tablets may be taken with or without food. Avoid grapefruit and grapefruit juice, which may increase diazepam levels in the body. Avoid alcohol entirely while taking Valium, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• If you take Valium on a schedule and miss a dose, take it as soon as you remember.
• If it is close to the time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• The rectal gel is used only when needed for seizure clusters, so a missed dose usually does not apply. Follow your provider's specific instructions.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Store the rectal gel in its original container at room temperature. Do not freeze.
• Keep out of the reach of children.

Disposal

Because Valium is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: Valium may be used in children for certain conditions under a provider's care. The oral form is generally not recommended for children under 6 months of age. Dosing is based on the child's weight and condition. Keep the medication out of the reach of children. If a child takes more than prescribed, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of Valium, including drowsiness, dizziness, confusion, and unsteadiness, which can raise the risk of falls. A provider may start at a lower dose and monitor closely. Take extra care when getting up or moving around.

Patients with Liver or Kidney Problems: Use with caution. A lower dose may be needed, since impaired organ function can increase drug levels and prolong effects. Your provider may adjust your dose and monitor you more closely.

Caregivers: Give the medication exactly as prescribed. If you are giving the rectal gel, make sure you understand the correct steps and when to call for emergency help. Watch for excessive sleepiness, slowed or shallow breathing, confusion, trouble waking the patient, or unusual changes in mood or behavior, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Valium suddenly after regular or prolonged use. Abrupt discontinuation can cause withdrawal symptoms, some of which may be serious or life-threatening.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include anxiety, trouble sleeping, irritability, sweating, tremor, muscle cramps, stomach upset, and, in severe cases, seizures.
• Some people may notice a return of anxiety or other symptoms worse than before (rebound symptoms) after stopping. This usually improves over time.
• Tell your provider if withdrawal symptoms occur so your taper can be adjusted.

Overdose Warning

An overdose of Valium can be serious and may be fatal, especially when combined with opioids, alcohol, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion
• Slurred speech
• Loss of coordination or unsteadiness
• Slowed or shallow breathing
• Weak or limp muscles
• Slow reflexes
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. A medicine called flumazenil may be used in some cases to reverse the effects of benzodiazepines.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Valium and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or difficult breathing, or extreme sleepiness, especially when combined with opioids or other CNS depressants.
• Complex sleep behaviors: Doing activities while not fully awake, such as sleep-walking, sleep-driving, or preparing food, with no memory of the event. These behaviors can cause serious injury or death.
• Angioedema and severe allergic reactions: Swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; hives; or a severe rash. These can be life-threatening and may occur after the first dose or later.
• Suicidal thoughts or worsening depression: New or worsening depression, or thoughts of harming yourself.
• Paradoxical reactions: Unexpected effects such as increased anxiety, agitation, restlessness, aggression, irritability, hallucinations, or unusual changes in behavior.
• Abnormal thinking or behavior changes: Confusion, feeling detached from reality, or memory problems.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Fatigue or tiredness
• Loss of coordination or unsteadiness (ataxia)
• Muscle weakness
• Blurred vision
• Dry mouth
• Headache

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Risks from Concomitant Use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions

• Risks from concomitant use with opioids: Combining benzodiazepines such as Valium with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative treatment options, and limit the dose and duration to the minimum required.
• Abuse, misuse, and addiction: The use of benzodiazepines, including Valium, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
• Dependence and withdrawal reactions: Continued use may lead to physical dependence. Stopping the medication suddenly or reducing the dose too quickly can cause serious, sometimes life-threatening, withdrawal reactions. To reduce this risk, the dose should be lowered gradually.

Conditions to Disclose to Your Healthcare Provider

Before taking Valium, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea
• Liver or kidney problems
• Depression, mood problems, or thoughts of suicide
• A history of unusual behavior or complex sleep behaviors while taking a sedative medicine
• Seizures or a seizure disorder
• Glaucoma, especially narrow-angle glaucoma
• Myasthenia gravis or other muscle weakness conditions
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Valium if you:

• Have a known hypersensitivity to diazepam or any component of the formulation
• Have acute narrow-angle glaucoma
• Have myasthenia gravis
• Have severe respiratory problems
• Have severe liver problems
• Have sleep apnea syndrome
• Are an infant younger than 6 months of age (for the oral form)

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because diazepam is processed mainly by the CYP3A4 and CYP2C19 liver enzymes, many drugs can affect its levels. Key interactions include:

• Opioids: Combining Valium with opioids increases the risk of severe drowsiness, respiratory depression, coma, and death.
• Other CNS depressants: Sedatives, tranquilizers, other sleep medicines, muscle relaxants, certain antidepressants, antihistamines, and antipsychotics can add to drowsiness and breathing problems.
• Alcohol: Drinking alcohol while taking Valium can dangerously increase sedation and the risk of slowed breathing. Avoid alcohol entirely.
• CYP3A4 and CYP2C19 inhibitors: Drugs such as certain antifungals (for example, ketoconazole, itraconazole), macrolide antibiotics, some HIV medications, cimetidine, omeprazole, and fluvoxamine may increase diazepam levels and the risk of side effects.
• CYP3A4 and CYP2C19 inducers: Drugs such as rifampin, carbamazepine, and phenytoin may reduce diazepam's effectiveness.
• Grapefruit and grapefruit juice: May increase diazepam levels in the body.
• Other sedating medicines: Any medicine that causes drowsiness may increase the sedative effects of Valium.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and whether your symptoms improve
• Signs of excessive sedation or respiratory depression, especially with other CNS depressants
• New or worsening mood, behavior, or mental health changes, including thoughts of self-harm
• Reports of complex sleep behaviors or paradoxical reactions
• Liver function during long-term use
• Signs of tolerance, dependence, or misuse
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Valium is a Schedule IV controlled substance.

• Benzodiazepines such as Valium can be misused and may be a target for people who abuse prescription medicines. The risk may be higher in people with a history of substance abuse.
• Physical dependence and tolerance can develop with continued use, even at prescribed doses. Physical dependence means you should not stop suddenly.
• Tolerance may develop, meaning the medication may become less effective over time. Do not increase your dose on your own.
• Do not sell or give away Valium. Doing so may harm others and is against the law.
• Misusing this medication can cause overdose and death, especially when combined with other substances.

Long-Term Use Considerations

• The safety and effectiveness of long-term use, generally beyond 4 months for anxiety, have not been fully established. Your provider should regularly reassess whether continued treatment is appropriate.
• Physical dependence and tolerance may develop with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term use may increase the risk of memory problems and cognitive effects, particularly in older adults.
• Do not take Valium for longer than prescribed without discussing it with your provider.

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Patient Counseling Information

Safe Medication Use

• Take Valium exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Do not stop taking Valium suddenly after regular use. Talk to your healthcare provider about a safe tapering plan.
• If you use the rectal gel, make sure you and your caregiver understand the correct steps and when to seek emergency help.
• Do not share Valium with anyone else. Sharing is dangerous and against the law.
• Keep Valium in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Opioids and CNS depressants: Do not use these with Valium unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Valium. Alcohol adds to the sedative effect and can be dangerous.
• Complex sleep behaviors: Stop taking Valium and tell your provider right away if you learn you have done activities such as driving, eating, or walking while not fully awake, with no memory of it.
• Driving and machinery: Valium can cause drowsiness, dizziness, and slowed thinking. Do not drive or operate heavy machinery until you know how it affects you.
• Grapefruit: Avoid grapefruit and grapefruit juice, which can increase diazepam levels in your body.
• Mental health: Tell your provider about any new or worsening depression, unusual behavior, or thoughts of self-harm.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant. Using Valium during pregnancy, especially later in pregnancy, may cause harm to the baby, including neonatal sedation and withdrawal symptoms after birth.
• Breastfeeding: Diazepam can pass into breast milk and may affect a nursing baby. Talk to your provider before breastfeeding while taking Valium.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Learn you have done activities while asleep or not fully awake, such as sleep-driving or sleep-walking
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Develop new or worsening depression, unusual behavior, or thoughts of harming yourself
• Experience a paradoxical reaction, such as increased anxiety, agitation, aggression, or hallucinations
• Notice memory problems, confusion, or feeling detached from reality
• Experience withdrawal symptoms after reducing or stopping the medication
• Have any symptom that concerns you or does not go away