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Medicine guide

Diazepam

5 mg/5mL · Solution

  • Prescription only
  • Controlled substance · CIV
  • Benzodiazepine
Active substance
Diazepam
Made by
Precision Dose Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-08-07

What it is

Benzodiazepine

Used for
  • Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Serious warning

Risks from concomitant use with opioids;

All warnings ↓
Good to know
  • Prescription only
  • Controlled substance (schedule IV) — extra rules apply to prescribing and refills
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
104other products contain Diazepam — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Diazepam is indicated for 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.
  • In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
  • Diazepam 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.
  • Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
  • The effectiveness of diazepam 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.

From the official label · 2025-08-07 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Peak level after1–1.5 h
Half-life1 h
Mostly cleared after≈ 5 hfive half-lives — our arithmetic
PeakHalf gone5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

N-desmethyldiazepam and temazepam are both further metabolized to oxazepam.

How it leaves the body

Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide conjugates.

With food

Absorption is delayed and decreased when administered with a moderate fat meal.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-08-07

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • RISKS FROM CONCOMITANT USE WITH OPIOIDS;
  • ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
  • Reserve concomitant prescribing of these drugs 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 (see WARNINGS AND PRECAUTIONS ).
  • The use of benzodiazepines, including diazepam, 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 an increased frequency of serious adverse outcomes.
  • Before prescribing diazepam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ).
  • The continued use of benzodiazepines, including diazepam, 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 diazepam 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 diazepam or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • Diazepam is contraindicated in patients with a known hypersensitivity to this drug and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age.
  • Diazepam is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome.
  • It may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 Dosage:
  • 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 To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam 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 ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death.
  • Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
  • 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.
  • If a decision is made to prescribe diazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
  • In patients already receiving an opioid analgesic, prescribe a lower initial dose of diazepam than indicated in the absence of an opioid and titrate based on clinical response.
  • If an opioid is initiated in a patient already taking diazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
  • Advise both patients and caregivers about the risks of respiratory depression and sedation when diazepam is used with opioids.
  • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS:
  • Drug Interactions ).
  • Abuse, Misuse, and Addiction The use of benzodiazepines, including diazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
  • Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE:Abuse ).
  • Before prescribing diazepam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
  • Use of diazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of diazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction.
  • Prescribe the lowest effective dosage;
  • avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug.
  • If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
  • Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION:
  • Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.
  • Acute Withdrawal Reactions The continued use of benzodiazepines, including diazepam, may lead to clinically significant physical dependence.
  • Abrupt discontinuation or rapid dosage reduction of diazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE:
  • Dependence ).
  • Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE:
  • Dependence ).
  • Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.
  • Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.
  • As with other agents that have anticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication.
  • Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.
  • Neonatal Sedation and Withdrawal Syndrome Use of diazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS:
  • Pregnancy ).
  • Monitor neonates exposed to diazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to diazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.
  • General If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed-particularly with known compounds that may potentiate the action of diazepam such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants (see Drug Interactions ).
  • 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.
  • Psychiatric and paradoxical reactions are known to occur
  • when using benzodiazepines (see ADVERSE REACTIONS ).
  • Should this occur, use of the drug should be discontinued.
  • These reactions are more likely to occur in children and the elderly.
  • A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.
  • Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see DRUG ABUSE AND DEPENDENCE ).
  • In debilitated patients, it is recommended that the dosage be limited to
  • Some loss of response to the effects of benzodiazepines may develop after repeated use of diazepam for a prolonged time.
  • Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when diazepam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider.
  • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see WARNINGS:
  • Risks from Concomitant Use with Opioids and PRECAUTIONS:
  • Drug Interactions ).
  • Abuse, Misuse, and Addiction Inform patients that the use of diazepam, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances.
  • Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS:
  • Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ).
  • Withdrawal Reactions Inform patients that the continued use of diazepam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of diazepam may precipitate acute withdrawal reactions, which can be life-threatening.
  • Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.
  • Instruct patients that discontinuation or dosage reduction of diazepam may require a slow taper (see WARNINGS:
  • Patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.
  • As is true of most CNS-acting drugs, patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
  • Pregnancy Advise pregnant females that use of diazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS:
  • Pregnancy ).
  • Nursing Advise patients that breastfeeding is not recommended during treatment with diazepam (see PRECAUTIONS:
  • Nursing Mothers ).
  • 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.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day (approximately 6 and 12 times, respectively, the maximum recommended human dose [MRHD = 1 mg/kg/day] on a mg/m 2 basis) for 80 and 104 weeks, respectively, an increased incidence of liver tumors was observed in males of both species.
  • The data currently available are inadequate to determine the mutagenic potential of diazepam.
  • Reproduction studies in rats showed decreases in the number of pregnancies and in the number of surviving offspring following administration of an oral dose of 100 mg/kg/day (approximately 16 times the MRHD on a mg/m 2 basis) prior to and during mating and throughout gestation and lactation.
  • No adverse effects on fertility or offspring viability were noted at a dose of 80 mg/kg/day (approximately 13 times the MRHD on a mg/m 2 basis).
  • Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including diazepam, during pregnancy.
  • Nursing Mothers Diazepam is present in breastmilk.
  • Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 months have not been established.
  • Geriatric Use In elderly patients, it is recommended that the dosage be limited to
  • Hepatic Insufficiency Decreases in clearance and protein binding, and increases in volume of distribution and half-life have been reported in patients with cirrhosis.
  • In such patients, a 2- to 5-fold increase in mean half-life has been reported.
  • Delayed elimination has also been reported for the active metabolite desmethyldiazepam.
  • Benzodiazepines are commonly implicated in hepatic encephalopathy.
  • Increases in half-life have also been reported in hepatic fibrosis and in both acute and chronic hepatitis (see CLINICAL PHARMACOLOGY:
  • Pharmacokinetics in Special Populations:
  • Hepatic Insufficiency ).
  • General If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed-particularly with known compounds that may potentiate the action of diazepam such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants (see Drug Interactions ).
  • 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.
  • Psychiatric and paradoxical reactions are known to occur
  • when using benzodiazepines (see ADVERSE REACTIONS ).
  • Should this occur, use of the drug should be discontinued.
  • These reactions are more likely to occur in children and the elderly.
  • A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.
  • Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see DRUG ABUSE AND DEPENDENCE ).
  • In debilitated patients, it is recommended that the dosage be limited to
  • Some loss of response to the effects of benzodiazepines may develop after repeated use of diazepam for a prolonged time.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Advise pregnant females that use of diazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS:
  • Neonatal Sedation and Withdrawal Syndrome and PRECAUTIONS:
  • Pregnancy ).
  • Instruct patients to inform their healthcare provider if they are pregnant.
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to diazepam during pregnancy (see Precautions, Pregnancy ).
  • Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including diazepam, during pregnancy.
  • Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/.
  • Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS:
  • Neonatal Sedation and Withdrawal Syndrome and Clinical Considerations ).
  • Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data ).
  • Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD=1 mg/kg/day] or greater on a mg/m 2 basis).
  • Cleft palate and encephalopathy are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis.
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates.
  • Monitor neonates exposed to diazepam during pregnancy and labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.
  • Monitor neonates exposed to diazepam during pregnancy for signs of withdrawal.
  • Manage these neonates accordingly (see WARNINGS:
  • Neonatal Sedation and Withdrawal Syndrome ).
  • Labor or Delivery Special care must be taken when diazepam is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates.
  • With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).
  • Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.
  • Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted.
  • In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings.
  • Animal Data Diazepam has been shown to produce increased incidences of fetal malformations in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately 20 times the maximum recommended adult dose [0.4 mg/kg/day] or greater on a mg/m 2 basis).
  • Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis.
  • In published animal studies, administration of benzodiazepines or other drugs that enhance GABAergic inhibition to neonatal rats has been reported to result in widespread apoptotic neurodegeneration in the developing brain at plasma concentrations relevant for seizure control in humans.
  • The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans.
  • Diazepam is present in breastmilk.
  • There are reports of sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines through breast milk.
  • Because of the potential for serious adverse reaction, including sedation and withdrawal symptoms in breastfed infants, advise patient that breastfeeding is not recommended during treatment with diazepam.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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 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 diazepam, 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.
  • At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.
  • Phenytoin There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma.
  • In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia.
  • Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.
  • In severe overdosage cases, patients may develop respiratory depression and coma.
  • Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS:
  • Dependence and Withdrawal Reactions ).
  • Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/ or alcohol are involved in the overdosage.
  • In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.
  • Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with longterm benzodiazepine use and physical dependency.
  • The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy.
  • Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus).
  • If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.
  • See the flumazenil injection Prescribing Information.
  • Consider contacting a poison center (1-800-222-1222), poisoncontrol.org, or a medical toxicologist for additional overdosage management recommendations.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

  • Controlled Substance Diazepam is a Schedule IV controlled substance.
  • Abuse Diazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction.
  • Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
  • Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.
  • Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
  • Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication.
  • Abuse and misuse may lead to addiction.
  • Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.
  • Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS:
  • Abuse, Misuse, and Addiction ).
  • The following adverse reactions have occurred with benzodiazepine abuse and/or misuse:
  • abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.
  • The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse:
  • delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death.
  • Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).
  • Dependence Physical Dependence Diazepam may produce physical dependence from continued therapy.
  • Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
  • Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening.
  • Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS:
  • Dependence and Withdrawal Reactions ).
  • To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage (see DOSAGE and ADMINISTRATION:
  • Discontinuation or Dosage Reduction of Diazepam and WARNINGS:
  • Dependence and Withdrawal Reactions ).
  • Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor.
  • More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.
  • Protracted Withdrawal Syndrome Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal.
  • Protracted withdrawal symptoms may last weeks to more than 12 months.
  • As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
  • Tolerance Tolerance to diazepam may develop from continued therapy.
  • Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
  • Tolerance to the therapeutic effect of diazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.
  • Diazepam is a Schedule IV controlled substance.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

Safety and effectiveness in pediatric patients below the age of 6 months have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • In elderly patients, it is recommended that the dosage be limited to
  • the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially to be increased gradually as needed and tolerated).
  • 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.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia.
  • The following have also been reported:
  • Central Nervous System confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo Gastrointestinal System constipation, nausea, gastrointestinal disturbances Special Senses blurred vision, diplopia, dizziness Cardiovascular System hypotension Psychiatric and Paradoxical Reactions stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, insomnia, sleep disturbances, and nightmares.
  • Inappropriate behavior and other adverse behavioral effects have been reported
  • when using benzodiazepines.
  • Should these occur, use of the drug should be discontinued.
  • They are more likely to occur in children and in the elderly.
  • Urogenital System incontinence, changes in libido, urinary retention Skin and Appendages skin reactions Laboratories elevated transaminases and alkaline phosphatase Other changes in salivation, including dry mouth, hypersalivation Antegrade amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
  • Amnestic effects may be associated with inappropriate behavior.
  • Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance.
  • Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.
  • Postmarketing Experience Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users.
  • The risk is increased in those taking concomitant sedatives (including alcohol), and in the elderly.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Diazepam Oral Solution The 5 mg per 5 mL oral solution is supplied as a (wintergreen-spice flavored) clear, orange-colored solution.
  • NDC 68094-750-62 5 mL per unit dose cup Thirty (30) cups per shipper
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF.

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Each 5 mL of Diazepam Oral Solution contains:
  • diazepam, USP 5 mg Inactive Ingredients The flavored 5 mg/5 mL Oral Solution contains bitterness modifier, citric acid, D&C Yellow No. 10, FD&C Red No.40, polyethylene glycol, propylene glycol, sodium citrate, sorbitol, water and wintergreen coriander spice blend.
  • Diazepam is a benzodiazepine derivative.
  • Chemically, diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one.
  • It is an off-white to yellow, crystalline powder, insoluble in water and has a molecular weight of 284.75.
  • Its structural formula is as follows: C 16 H 13 CIN 2 O Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Colour dyesD&C Yellow No. 10; FD&C Red No.40Some people react to dyes such as tartrazine (Yellow 5) or carmine.
  • Sugar alcoholssorbitolSorbitol and similar can upset the stomach and matter with fructose intolerance.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (4)

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Details

Made byPrecision Dose Inc.
Active substanceDiazepam
Used inPain, sleep, mood, epilepsy and the brain
Strength5 mg/5mL
FormSolution
RouteOral
Packs3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
NDC68094-750

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

100 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Diazepam5 mg/5mLPrescription onlySolution Hikma Pharmaceuticals USA Inc. · DiazepamDiazepam5 mg/5mLPrescription onlySolution Pharmaceutical Associates, Inc. · DiazepamDiazepam2 mgPrescription onlyTablet Teva Pharmaceuticals USA, Inc. · DiazepamDiazepam5 mgPrescription onlyTablet Teva Pharmaceuticals USA, Inc. · DiazepamDiazepam10 mgPrescription onlyTablet Teva Pharmaceuticals USA, Inc. · DiazepamDiazepam2 mgPrescription onlyTablet Mylan Pharmaceuticals Inc. · Diazepam

See every product with Diazepam