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Diazepam

Diazepam is a benzodiazepine used for anxiety, acute alcohol withdrawal, muscle spasm, and seizures, with some uses limited to specific forms such as injection, rectal gel, and Valtoco nasal spray.

Brand names Diazepam IntensolValiumValreleaseValtocoLibervant +1 more
Drug class Benzodiazepine
Rx Schedule CIV Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 8, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 76 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 9, 2026
Other forms & routes:
Diazepam at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Diazepam (Valium) is a benzodiazepine used for anxiety, alcohol withdrawal, muscle spasm and seizures. It calms overactive nerve signaling by boosting GABA, the brain's calming chemical messenger, and it is an older standby, on the market since about 1963 and available generically. Most people tolerate it well short term, and the effects they notice are drowsiness and unsteadiness or poor coordination. Its boxed warning covers profound sedation, dangerously slowed breathing, coma and death when combined with opioids (alcohol raises the danger too), plus risks of misuse, addiction and physical dependence. After regular use, never stop suddenly, since withdrawal can cause seizures, so ask your prescriber about a gradual taper.

Clinical pearls

  • Older adults clear diazepam more slowly, so unsteadiness and oversedation can build up, and lower doses are often used.
  • Ketoconazole, clotrimazole and cimetidine can raise diazepam levels, while rifampin, carbamazepine and phenytoin can weaken its effect.
  • Valtoco nasal spray and diazepam rectal gel are rescue treatments for seizure clusters, meant for occasional use, never daily.
  • Hold off on driving, operating machinery or biking until you know how diazepam affects you.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Combining diazepam with opioids can cause extreme sleepiness, slowed breathing, coma, and death. Doctors should only prescribe them together when other options are not enough, using the lowest dose and shortest time.

Benzodiazepines also carry a risk of abuse, misuse, and addiction, which can lead to overdose or death. Risk is higher when mixed with alcohol or other substances.

Regular use can cause physical dependence. Stopping suddenly or cutting the dose quickly can trigger life-threatening withdrawal reactions. Talk to your prescriber about a gradual taper before stopping. Valtoco is meant only for occasional use, but using it more often than directed carries these risks.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Injection, Oral solution +2
Earliest FDA record1963
Companies listing it with the FDA47
FDA label last updatedAug 11, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient Information Guide A plain-language walkthrough of Diazepam, written from its FDA label.

What Diazepam Is Used For

▾

Diazepam is used for several conditions, depending on the product.

  • Valium tablets, diazepam oral solution, and Diazepam Intensol: anxiety disorders and short-term relief of anxiety symptoms.
  • Oral products: relief of symptoms in acute alcohol withdrawal.
  • Oral products: add-on for muscle spasm, spasticity (cerebral palsy, paraplegia), athetosis, and stiff-man syndrome.
  • Oral products: add-on for convulsive disorders, though not useful as sole therapy.
  • Diazepam injection: anxiety, alcohol withdrawal, and muscle spasm including tetanus.
  • Diazepam injection: before endoscopic procedures, before surgery, and intravenously before cardioversion.
  • Diazepam injection: add-on for status epilepticus and severe recurrent convulsive seizures.
  • Valtoco nasal spray and diazepam rectal gel: seizure clusters in people with epilepsy ages 2 and older.

How Diazepam Works

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The exact mechanism isn't fully understood. Diazepam is thought to attach to the benzodiazepine site on the GABA-A receptor and boost GABA, a calming brain chemical. This slows overactive nerve activity, producing anti-anxiety, sedating, muscle-relaxing, and anti-seizure effects.

Diazepam Dosage

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Each product has its own regimen, so follow your prescriber and label.

  • Valium tablets and oral solutions: taken by mouth, usually several times a day, with the dose individualized.
  • Food can delay and reduce absorption of oral diazepam.
  • Injection: given by a healthcare professional into a muscle or vein.
  • Valtoco: a nasal spray for seizure clusters only, with limits on repeat doses and episodes.
  • Diazepam rectal gel: given rectally for seizure clusters.

Dosing details from the FDA-approved label

From the Diazepam prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Valtoco nasal spray: adults and pediatric patients 2 years and older (seizure clusters)
    • 0.2 mg/kg to 0.5 mg/kg depending on age and weight: 2 through 5 years 0.5 mg/kg
    • 6 through 11 years 0.3 mg/kg
    • 12 and older 0.2 mg/kg. 5 mg and 10 mg doses are one spray in one nostril
    • 15 mg and 20 mg doses use two devices, one spray in each nostril
    • A second dose, when required, may be given at least 4 hours after the initial dose, using a new blister pack
    • Maximum: Do not use more than 2 doses to treat a single episode; no more than one episode every five days and no more than five episodes per month
    • Dose depends on age and weight
  • Adults: Management of Anxiety Disorders and Relief of Symptoms of Anxiety (oral)
    • 2 mg to 10 mg, 2 to 4 times daily, depending upon severity of symptoms
    • Individualize dosage; increase cautiously if higher doses are needed
  • Adults: Symptomatic Relief in Acute Alcohol Withdrawal (oral)
    • 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
  • Adults: Adjunctively for Relief of Skeletal Muscle Spasm (oral)
    • 2 mg to 10 mg, 3 or 4 times daily
  • Adults: Adjunctively in Convulsive Disorders (oral)
    • 2 mg to 10 mg, 2 to 4 times daily
  • Geriatric patients, or in the presence of debilitating disease (oral)
    • 2 mg to 2.5 mg, 1 or 2 times daily initially
    • Increase gradually as needed and tolerated
    • Geriatric or debilitating disease
  • Pediatric patients (oral)
    • 1 mg to 2.5 mg, 3 or 4 times daily initially
    • Increase gradually as needed and tolerated
    • Not for use in pediatric patients under 6 months; initiate with lowest dose
  • Injection: older children and adults, usual recommended dose
    • 2 mg to 20 mg intramuscular or intravenous, depending on indication and severity
    • In acute conditions may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory
    • In some conditions, e.g., tetanus, larger doses may be required
  • Injection: elderly or debilitated patients, or when other sedative drugs are administered
    • Lower doses (usually 2 mg to 5 mg) and slow increase in dosage
    • Elderly or debilitated
  • Injection: Moderate Anxiety Disorders and Symptoms of Anxiety
    • 2 mg to 5 mg, intramuscular or intravenous
    • Repeat in 3 to 4 hours, if necessary
    • IV: inject slowly, at least one minute for each 5 mg (1 mL)
Read the label’s full dosing text

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. ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms—2 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. PEDIATRIC PATIENTS: 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. Discontinuation or Dosage Reduction of Diazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).

Read the full Dosage and Administration section on DailyMed →

Diazepam Side Effects

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Common side effects include:

Common side effects

  • Sleepiness or drowsiness (somnolence)
  • Headache
  • Nasal discomfort (with Valtoco)
  • Diarrhea (seen with diazepam rectal gel)
  • Unsteadiness or poor coordination

When to get medical help

  • Slow or shallow breathing, extreme sleepiness, or can't be woken, especially if you also take opioids or alcohol
  • New or worsening depression, suicidal thoughts, or unusual mood or behavior changes
  • Seizures, severe agitation, or other withdrawal symptoms after stopping or cutting down suddenly
  • Signs of misuse or addiction, such as taking more than prescribed
  • Rash or hives
  • Agitation, aggression, or restlessness instead of calm (rare reactions)
  • Eye pain or vision changes if you have glaucoma

Diazepam Warnings and Precautions

▾
  • Using diazepam with opioids can cause profound sedation, slowed breathing, coma, and death.
  • It carries risks of abuse, misuse, and addiction.
  • Dependence can develop, and stopping suddenly can cause life-threatening withdrawal. Taper gradually.
  • It causes drowsiness, so avoid driving or hazardous tasks until you know how it affects you.
  • It may raise eye pressure in glaucoma.
  • Antiepileptic drugs can slightly raise the risk of suicidal thoughts.
  • Late pregnancy use can cause sedation or withdrawal in newborns.

Diazepam Interactions

▾

Several substances can change how diazepam works or add to its effects.

  • Opioids: greatly increase the risk of slowed breathing and death.
  • Alcohol and other CNS depressants: add to sedation.
  • Cimetidine, quinidine, tranylcypromine, ketoconazole, clotrimazole: can raise diazepam levels.
  • Rifampin, carbamazepine, phenytoin, dexamethasone, phenobarbital: can lower diazepam levels.
  • Warfarin, omeprazole, propranolol, imipramine, cyclosporine, paclitaxel, theophylline: diazepam may affect their metabolism.

Interactions listed in the FDA-approved label

From the Diazepam prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Opioids: Concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use, and follow patients closely for respiratory depression and sedation.
  • Other CNS depressants (e.g., valproate) and alcohol: May potentiate the CNS-depressant effects of diazepam.
  • CYP2C19 inhibitors (e.g., cimetidine, quinidine, tranylcypromine): Could decrease the rate of diazepam elimination, so adverse reactions may be increased.
  • CYP3A4 inhibitors (e.g., ketoconazole, troleandomycin, clotrimazole): Could decrease the rate of diazepam elimination, so adverse reactions may be increased.
  • CYP2C19 inducers (e.g., rifampin): Could increase the rate of diazepam elimination, so efficacy may be decreased.
  • CYP3A4 inducers (e.g., carbamazepine, phenytoin, dexamethasone, phenobarbital): Could increase the rate of diazepam elimination, so efficacy may be decreased.
  • CYP2C19 substrates (e.g., omeprazole, propranolol, imipramine): Diazepam may interfere with their metabolism, leading to a potential drug-drug interaction.
  • CYP3A4 substrates (e.g., cyclosporine, paclitaxel, theophylline, warfarin): Diazepam may interfere with their metabolism, leading to a potential drug-drug interaction.
Read the label’s full interactions text

Drug Interactions Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. Centrally Acting Agents If diazepam tablets are 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 diazepam tablets, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants. Alcohol Concomitant use with alcohol is not recommended due to enhancement of the sedative effect. Antacids Diazepam peak concentrations are 30% lower when antacids are administered concurrently. However, there is no effect on the extent of absorption. The lower peak concentrations appear due to a slower rate of absorption, with the time required to achieve peak concentrations on average 20-25 minutes greater in the presence of antacids. However, this difference was not statistically significant. Compounds Which Inhibit Certain Hepatic Enzymes 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.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before Taking Diazepam

▾
  • Allergy to diazepam.
  • Tablets: not for children under 6 months, or with myasthenia gravis, severe respiratory insufficiency, severe liver problems, or sleep apnea.
  • Narrow-angle glaucoma; open-angle glaucoma only with appropriate treatment.
  • Pregnancy and breastfeeding: infants may be sedated or have withdrawal; breastfed babies should be monitored.
  • Older adults: slower clearance, so lower doses are recommended.
  • Lung problems such as asthma or pneumonia.
  • Valtoco is not approved for infants under 2 years and contains benzyl alcohol.

Diazepam Overdose

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Too much diazepam can cause drowsiness, confusion, poor coordination, and weak muscles, and in severe cases slowed breathing and coma. Combining it with alcohol or opioids can be fatal. Seek emergency care or call Poison Help at 1-800-222-1222.

What Diazepam Does in the Body

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Diazepam's effects on the central nervous system depend on the dose, the route, and whether other medicines are on board. It produces anxiety relief, sedation, muscle relaxation, anticonvulsant effects, and memory-blunting (amnestic) effects.

How Your Body Processes Diazepam

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Over 90% of oral diazepam is absorbed, with peak levels in about 1 to 1.5 hours; food delays and lowers absorption. Valtoco peaks in about 1.5 hours with 97% bioavailability compared with IV. The liver breaks diazepam down with CYP2C19 and CYP3A4 into active metabolites. Its half-life is long (about 49 hours with Valtoco) and grows longer with age and with liver disease.

How to Store Diazepam

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

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

244

Supplements & Herbs That Interact With Diazepam

244 supplements and herbal products have documented interactions with Diazepam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 191
  • Minor · 44
Every supplement checked against Diazepam — ranked by severity The full interaction hub: 9 major · 191 moderate · 44 minor · every one linked to its full report. Check Diazepam against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient Depletion Considerations

Diazepam has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Diazepam nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Diazepam: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Diazepam — the kind of thing our pharmacy team would talk through with you at the counter.

What is diazepam actually for?

▾
It depends on the form. Tablets and oral solution are used for anxiety, alcohol withdrawal symptoms, muscle spasm, and as an add-on for seizure disorders. Valtoco nasal spray and rectal gel are only for seizure clusters in people with epilepsy ages 2 and older.

Can I drink alcohol while taking it?

▾
No. Alcohol adds to the sedation and can slow your breathing. Avoid it while on diazepam.

Is it safe with my opioid pain medicine?

▾
This combination is risky. It can cause extreme sleepiness, slowed breathing, coma, and death. Tell your prescriber about every opioid you take.

Can I stop it suddenly?

▾
Please don't. If you have been taking it regularly, stopping suddenly can cause serious withdrawal, including seizures. Your prescriber can set up a gradual taper.

What side effects should I expect?

▾
Sleepiness and headache are the most common. Valtoco can cause nasal discomfort. Call for help if you have trouble breathing, mood changes or suicidal thoughts, rash, or can't stay awake.

Is it okay in pregnancy or breastfeeding?

▾
Use late in pregnancy can make newborns sleepy or cause withdrawal symptoms. Diazepam also passes into breast milk. Talk with your doctor about the benefits and risks first.

Is Diazepam available over the counter?

▾
No. Diazepam is a prescription medicine: every Diazepam product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Diazepam a controlled substance?

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Yes — Diazepam is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Diazepam first available?

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The earliest FDA record we hold for Diazepam is from 1963: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Diazepam was first used.

Who makes Diazepam?

▾
47 companies currently list Diazepam products in the FDA's NDC Directory, including Bryant Ranch Prepack, Asclemed Usa Inc., A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Diazepam on HelloPharmacist

Detailed Data & References for Diazepam Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Diazepam Forms and Strengths (How It Comes)

Diazepam is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Diazepam inactive ingredients by manufacturer.

Tablet

By mouth
Brands Valium
How this form is used
What it may be used for
  • Valium is used for anxiety disorders or short-term relief of anxiety symptoms.
  • Valium may help with symptoms of acute alcohol withdrawal.
  • Valium is used as an add-on for muscle spasm and for convulsive disorders, but not as the only seizure treatment.
Important instructions
  • Valium is taken by mouth, usually 2 to 4 times a day depending on the condition.
  • Valium dosing is individualized, with lower starting doses for older or debilitated people, and the prescriber should recheck its usefulness from time to time.
  • Diazepam tablets taken with a fatty meal are absorbed more slowly and to a lesser degree than when taken fasting.
Available strengths 3 strengths
168 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein
How this form is used
What it may be used for
  • Diazepam injection is used for anxiety disorders or short-term relief of anxiety symptoms.
  • Diazepam injection may help with symptoms of acute alcohol withdrawal, such as agitation, tremor and delirium tremens.
  • Diazepam injection is used as an add-on for status epilepticus, muscle spasm, and to ease anxiety before endoscopy, cardioversion or surgery.
Important instructions
  • Diazepam injection is given into a muscle or a vein, depending on the reason it is needed.
  • Diazepam injection may be repeated within an hour in acute conditions, though a 3 to 4 hour gap is usually enough.
  • Diazepam injection given into a vein is given where equipment to help breathing is readily available.
  • Diazepam autoinjector is for use in the muscle only, with the black end pressed on the middle of the outer thigh and held in place for 10 seconds.
Available strengths 3 strengths
51 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Diazepam Intensol
How this form is used
What it may be used for
  • Diazepam oral solution and Diazepam Intensol are used for anxiety disorders or short-term relief of anxiety symptoms.
  • Diazepam oral solution and Diazepam Intensol may ease symptoms of acute alcohol withdrawal.
  • Diazepam oral solution and Diazepam Intensol are used as an add-on for muscle spasm and for convulsive disorders, but not as the only treatment for seizures.
Important instructions
  • Diazepam oral solution and Diazepam Intensol are taken by mouth, usually several times a day depending on the condition.
  • Diazepam oral solution and Diazepam Intensol doses are individualized, with lower starting doses for older or debilitated people.
Available strengths 2 strengths
18 FDA-listed product records ⓘ

Rectal cream, ointment or gel

Rectal
How this form is used
What it may be used for
  • Diazepam rectal gel is used for sudden seizure clusters (repeated seizure episodes different from a person’s usual pattern) in people with epilepsy age 2 and older.
Important instructions
  • Diazepam rectal gel is meant to be given by a caregiver who can recognize the person’s seizure clusters.
  • Diazepam rectal gel is used along with the person’s regular seizure medicines, not in place of them.
Available strengths 5 strengths
16 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Valtoco
How this form is used
What it may be used for
  • Valtoco is used for sudden seizure clusters (repeated seizure episodes different from a person’s usual pattern) in people with epilepsy age 2 and older.
Important instructions
  • Valtoco is sprayed into the nose only.
  • Valtoco is given as one spray in one nostril for some doses, or one spray in each nostril using two devices for others, based on age and weight.
  • Valtoco may have a second dose given at least 4 hours after the first, using a new blister pack.
  • Valtoco should not be used for more than 2 doses per episode, and is advised for no more than one episode every five days and five per month.
Available strengths 3 strengths
12 FDA-listed product records ⓘ

Diazepam on the U.S. Market: Products, Makers and Brands

How Diazepam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

47 companies list 127 Diazepam product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1963. Brand names on the directory include Diazepam Intensol, Valium, Valrelease and 3 more; the rest are generics.

5
Dose forms ⓘ
47
Labelers (makers, repackagers, distributors)
4
Brand names
127
FDA-listed product records ⓘ
1963
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (9) · Unfinished spray (3) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack6%
Asclemed Usa Inc.5%
A-S Medication Solutions4%
Chartwell RX, LLC4%
Hikma Pharmaceuticals USA Inc.4%
NuCare Pharmaceuticals,Inc.4%
Other makers74%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How Widely Diazepam Is Used (Medicaid Data)

A general measure of how commonly Diazepam is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Diazepam is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,216,820
Medicaid prescriptions filled (Q1–Q4 2025)
$281.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Diazepam prescribed? Of the 1,603 medications we measure, Diazepam ranks #147 by Medicaid prescriptions — more than 91% of them.

Where Diazepam ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Diazepam product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg oral tablet is the most-dispensed Diazepam product — about 42% of these Medicaid prescriptions.

diazepam 5 MG Oral Tablet Most dispensed

509,781 Medicaid prescriptions (Q1–Q4 2025) 42% of Diazepam prescriptions shown $4.2M gross reimbursement (before rebates) ≈ $8.26 per prescription (gross)

Summed across the 9 of 301 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197591

diazepam 10 MG Oral Tablet

272,290 Medicaid prescriptions (Q1–Q4 2025) 22% of Diazepam prescriptions shown $2.3M gross reimbursement (before rebates) ≈ $8.56 per prescription (gross)

Summed across the 8 of 247 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197589

diazepam 2 MG Oral Tablet

156,059 Medicaid prescriptions (Q1–Q4 2025) 13% of Diazepam prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $7.77 per prescription (gross)

Summed across the 5 of 99 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197590

diazepam 1 MG/ML Oral Solution

50,198 Medicaid prescriptions (Q1–Q4 2025) 4% of Diazepam prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309843

2 ML diazepam 5 MG/ML Rectal Gel

28,610 Medicaid prescriptions (Q1–Q4 2025) 2% of Diazepam prescriptions shown $10M gross reimbursement (before rebates) ≈ $349 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 801961

2 ML diazepam 5 MG/ML Cartridge

12,165 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $706,428 gross reimbursement (before rebates) ≈ $58 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1807459

2 ML diazepam 5 MG/ML Prefilled Syringe

8,752 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $472,701 gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 7 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2120550

4 ML diazepam 5 MG/ML Rectal Gel

5,737 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $383 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 801966

diazepam 5 MG/ML Oral Solution

2,441 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $122,433 gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309844

0.5 ML diazepam 5 MG/ML Rectal Gel

2,403 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $715,920 gross reimbursement (before rebates) ≈ $298 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 801957

diazepam 5 MG/ML Injectable Solution

345 Medicaid prescriptions (Q1–Q4 2025) <1% of Diazepam prescriptions shown $38,640 gross reimbursement (before rebates) ≈ $112 per prescription (gross)

Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309845

Other Diazepam products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

168,039 Medicaid prescriptions (Q1–Q4 2025) 14% of Diazepam prescriptions shown $258.5M gross reimbursement (before rebates) ≈ $1,538 per prescription (gross)

Summed across the 8 of 43 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Diazepam, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 47 of 765 listed Diazepam NDCs with Medicaid activity.

Compare Diazepam Products

A representative set of FDA-listed product records for Diazepam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 127 of 127 products — FDA National Drug Code Directory. See every product, package size and price: browse all 127 Diazepam NDCs →

Diazepam Side Effects Reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Diazepam — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Diazepam are toxicity to various agents, drug abuse, nausea; about 81% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

121,010
Reports mentioning it
81%
Reported as serious
12
Distinct effects shown
Most reported effects
Toxicity To Various Agents
9,513
Drug Abuse
7,212
Nausea
6,290
Fatigue
5,836
Pain
5,267
Anxiety
5,085
Somnolence
5,079
Headache
5,072
Dizziness
4,565
Vomiting
4,523
Age groups
Adult · 9,363Elderly · 3,178Adolescent · 354Child · 301Neonate · 288Infant · 115

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Diazepam in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Diazepam FDA Approval History

How Diazepam went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Diazepam was first approved by the FDA in 1963 (Brand: VALIUM · Waylis Therap); the first generic version was approved in 1985. It remains available in U.S. pharmacies today.

1963
Brand approved
Brand: VALIUM · Waylis Therap
1985
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Diazepam Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Diazepam recalls since July 2021.

✅No Diazepam recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Diazepam RxCUI 3322 15 dose forms · 28 strengths
  1. Dose form (SCDF) Auto-Injector RxCUI 1807451 In current FDA listings
    Clinical drug / strength (SCD) 2 ML diazepam 5 MG/ML RxCUI 1807452
  2. Dose form (SCDF) Buccal Film RxCUI 2682563 No current FDA listing
    Clinical drug / strength (SCD) 5 MG RxCUI 2682564 7.5 MG RxCUI 2682581 10 MG RxCUI 2682571 12.5 MG RxCUI 2682575 15 MG RxCUI 2682578
  3. Dose form (SCDF) Cartridge RxCUI 1807458 In current FDA listings
    Clinical drug / strength (SCD) 2 ML diazepam 5 MG/ML RxCUI 1807459
  4. Dose form (SCDF) Enema RxCUI 439063 No current FDA listing
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 422658 4 MG/ML RxCUI 422657
  5. Dose form (SCDF) Extended Release Oral Capsule RxCUI 371780 No current FDA listing
  6. Dose form (SCDF) Injectable Solution RxCUI 371782 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 309845
  7. Dose form (SCDF) Injectable Suspension RxCUI 381031 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 105032
  8. Dose form (SCDF) Nasal Spray RxCUI 2272612 In current FDA listings
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 2272626 75 MG/ML RxCUI 2272632 100 MG/ML RxCUI 2272613
  9. Dose form (SCDF) Oral Capsule RxCUI 375801 No current FDA listing
  10. Dose form (SCDF) Oral Solution RxCUI 371781 In current FDA listings
    Clinical drug / strength (SCD) 0.4 MG/ML RxCUI 141926 1 MG/ML RxCUI 309843 5 MG/ML RxCUI 309844
  11. Dose form (SCDF) Oral Suspension RxCUI 379421 No current FDA listing
    Clinical drug / strength (SCD) 0.5 MG/ML RxCUI 108379 2 MG/ML RxCUI 108380
  12. Dose form (SCDF) Oral Tablet RxCUI 371786 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 197590 5 MG RxCUI 197591 10 MG RxCUI 197589
  13. Dose form (SCDF) Prefilled Syringe RxCUI 2120549 In current FDA listings
    Clinical drug / strength (SCD) 2 ML diazepam 5 MG/ML RxCUI 2120550 4 ML diazepam 5 MG/ML RxCUI 2749119
  14. Dose form (SCDF) Rectal Suppository RxCUI 371784 No current FDA listing
    Clinical drug / strength (SCD) 10 MG RxCUI 104706

Look up RxCUI 3322 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Diazepam Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Oct 7, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 10 mg $0.028 per tablet NDC details & price history
Gel · Rectal 10 mg/2 g $208.71 each NDC details & price history
Solution · Oral 5 mg/5 mL $0.107 per mL NDC details & price history
Solution · Oral 5 mg/mL $1.06 per mL NDC details & price history
Spray · Nasal 10 mg/0.1 mL $365.47–$366.66 each NDC details & price history
Spray · Nasal 5 mg/0.1 mL $366.14–$366.86 each NDC details & price history
Spray · Nasal 7.5 mg/0.1 mL $365.51–$366.59 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Diazepam Brand Names

Diazepam is sold under 6 brand names in the FDA directory — Diazepam Intensol, Valium, Valrelease, Valtoco and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Diazepam Intensol Valium Valrelease Valtoco Libervant Diastat

Who Makes Diazepam: Manufacturers and Labelers

47 companies list Diazepam products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Asclemed Usa Inc., A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 7 Asclemed Usa Inc. 6 A-S Medication Solutions 5 Chartwell RX, LLC 5 Hikma Pharmaceuticals USA Inc. 5 NuCare Pharmaceuticals,Inc. 5 Remedyrepack Inc. 5 Direct_Rx 4 Neurelis, Inc 4 PD-Rx Pharmaceuticals, Inc. 4 Advanced Rx of Tennessee, LLC 3 Aphena Pharma Solutions - Tennessee, LLC 3 Aurobindo Pharma Limited 3 Clinical Solutions Wholesale, LLC 3 Henry Schein, Inc. 3 Mylan Institutional Inc. 3 Mylan Pharmaceuticals Inc. 3 Navinta LLC 3 Oceanside Pharmaceuticals 3 Proficient Rx LP 3 Safecor Health, LLC 3 Sunrise Pharmaceutical, Inc. 3 Teva Pharmaceuticals USA, Inc. 3 Waylis Therapuetics LLC 3

…and 23 more on the FDA NDC directory.

Diazepam Drug Class (RxNorm)

Diazepam belongs to the Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Diazepam Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 11, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Diazepam.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Diazepam after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
76
Finished products in the current FDA directory
127
Companies listing them (makers, repackagers, distributors)
47
FDA labeler codes behind them ⓘ
52
Linked representative label ⓘ
Waylis Therapuetics LLC
Linked label effective
Aug 11, 2026
Composite sections available
23
Linked SPL Set ID
260e2041-2bb3-482f-850e-b5d47a7bdbe6
Linked SPL Document ID
162faa32-b6de-4c5d-a971-c908c9a951d2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Waylis Therapuetics LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →