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Diazepam

    DEA Class;  Rx

    Common Brand Names; Valium, Diastat, Diastat AcuDial, Valtoco, 

    •  Antianxiety Agents; 
    • Anxiolytics, Benzodiazepines; 
    • Skeletal Muscle Relaxants; 
    • Anticonvulsants, Benzodiazepine

    Oral, nasal, parenteral, or rectal long-acting benzodiazepine
    Used for anxiety, acute alcohol withdrawal, skeletal muscle spasm, and seizure disorders
    Increased risk of profound sedation, respiratory depression, coma, and death with concomitant opioid use

    Indicated for management of anxiety disorders or for short-term relief of the symptoms of anxiety

    Aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, hallucinations

    Adjunct use, if apprehension, anxiety or acute stress reactions present prior to endoscopic procedures

    May be used adjunctively for relief of skeletal muscle spasm due to reflex spasm to local pathology (eg, inflammation of the muscles or joints, secondary to trauma); spasm associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus

    Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) distinct from a patient’s usual seizure pattern

    Documented hypersensitivity

    Acute alcohol intoxication

    Myasthenia gravis (allowable in limited circumstances)

    Acute narrow-angle glaucoma and open-angle glaucoma unless patients receiving appropriate therapy

    Severe respiratory depression

    IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants

    Sleep apnea

    Children <6 months

    Severe hepatic insufficiency (PO)

    • Ataxia (3%)
    • Euphoria (3%, rectal gel)
    • Incoordination (3%, rectal gel)
    • Somnolence (>1%)
    • Rash (3%, rectal gel)
    • Diarrhea (4%, rectal gel)
    • Dizziness (3%; rectal gel)
    • Asthma (2%; rectal gel)
    • Hypotension
    • Fatigue
    • Muscle weakness
    • Respiratory depression
    • Urinary retention
    • Depression
    • Incontinence
    • Blurred vision
    • Dysarthria
    • Headache
    • Skin rash
    • Changes in salivation
    • Drowsiness
    • Venous thrombosis
    • Confusion
    • Hypoactivity
    • Slurred speech
    • Syncope
    • Tremor
    • Vertigo
    • Constipation
    • Nausea
    • Changes in libido
    • Bradycardia

    Efficacy and safety of parenteral diazepam has not been established in neonate (30 days or less of age); prolonged central nervous system depression has been observed in neonates, apparently due to inability to biotransform diazepam into inactive metabolites; benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants

    Not recommended for chronic, daily use as an anticonvulsant because of potential for development of tolerance to diazepam; chronic daily use of diazepam may increase frequency and/or severity of tonic-clonic seizures, requiring an increase in dosage of standard anticonvulsant medication; in such cases, abrupt withdrawal of chronic diazepam may also be associated with a temporary increase in the frequency and/or severity of seizures

    Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate; reduce opiate dose one-third when diazepam is added

    Advise both patients and caregivers about 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

    Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicide ideation, impaired gag reflex, history of drug abuse, or obese patients (prolonged action when discontinued)

    Use of benzodiazepines, including diazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression

    May impair ability to perform hazardous tasks

    Use with caution in patients with a history of drug abuse or acute alcoholism; tolerance, psychological, and physical dependence may occur with prolonged use (>10 days)

    Use of drug, particularly in patients at elevated risk, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

    Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as diazepam injection, during pregnancy

    Present in breastmilk

    Reports of sedation, poor feeding and poor weight gain in infants exposed to diazepam through breast milk; there are no data on effects of diazepam on milk production

    Adults

    Dosage must be individualized. Suggested maximum doses: 40 mg/day PO in divided doses for chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.

    Geriatric

    Dosage must be individualized. Suggested maximum dose: 40 mg/day PO in divided doses for many chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.

    Adolescents

    Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.

    Children

    Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.

    Infants

    Maximum dosage not established.

    Neonates

    Maximum dosage not established.

    Diazepam

    tablet: Schedule IV

    • 2mg

    • 5mg

    • 10mg

    oral solution: Schedule IV

    • 1mg/1mL

    • 5mg/mL

    rectal gel: Schedule IV

    • 2.5mg

    • 10mg

    • 20mg

    injectable solution: Schedule IV

    • 5mg/mL

    intramuscular device: Schedule IV

    • 5mg/mL

    intranasal spray: Schedule IV

    • 5mg/0.1mL

    • 7.5mg/0.1mL

    • 10mg/0.1mL