Usual Adult Dose for Anxiety

ORAL:
Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
Maintenance dose: 1 to 2 mg orally 2 to 3 times a day

Comments:

• The daily dosage may vary from 1 to 10 mg/day.
• The dosage should be increased gradually when needed to help avoid adverse effects.
• When higher dosage is indicated, the evening dose should be increased before the daytime doses.
• Use of anxiolytic agents is typically not needed to treat anxiety/tension associated with the stress of everyday life.
• Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Uses:

• Management of anxiety disorders
• Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Adult Dose for Light Anesthesia

INJECTION:
IM: 0.05 mg/kg IM ONCE

• Maximum dose: 4 mg

IV: 2 mg total OR 0.044 mg/kg IV ONCE, whichever is smaller

Comments:

• Doses of other injectable central-nervous-system depressant drugs should be reduced.
• Narcotic analgesics should be administered at their usual preoperative time.
• IV: The recommended dose of 2 mg (OR 0.44 mg/kg, whichever is smaller) should not ordinarily be exceeded in patients over 50 years of age.
• IV: Doses up to 0.05 mg/kg (4 mg maximum) may be administered.
• IM: For optimum effect, this route should be administered at least 2 hours before the anticipated operative procedure.
• IV: For optimum effect, this route should be administered 15 to 20 minutes before the anticipated operative procedure.

Use: As a preanesthetic medication to produce sedation (sleepiness or drowsiness), relieve anxiety, and decrease the ability to recall events related to the day of surgery

Usual Adult Dose for Status Epilepticus

INJECTION: 4 mg IV given at a rate of 2 mg/min; may repeat the dose in 10 to 15 minutes

• Maximum total dose: 8 mg

Comments:

• Vital signs should be monitored, an unobstructed airway should be maintained, and artificial ventilation equipment should be available.
• When an intravenous port is not available, the IM route may prove useful.

Use: Treatment of status epilepticus

Usual Adult Dose for Insomnia

ORAL: 2 to 4 mg orally once a day at bedtime

Comments:

• The dosage should be increased gradually when needed to help avoid adverse effects.
• Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Use: Management of insomnia due to anxiety of transient situational stress

Usual Geriatric Dose for Anxiety

ORAL:
Older or debilitated patients:

• Initial dose: 1 to 2 mg orally per day, given in divided doses

Comments:

• The dosage should be increased gradually when needed to help avoid adverse effects.
• The daily dosage may vary from 1 to 10 mg/day.
• When higher dosage is indicated, the evening dose should be increased before the daytime doses.
• Use of anxiolytic agents is typically not needed to treat anxiety/tension associated with the stress of everyday life.
• Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Uses:

• Management of anxiety disorders
• Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Pediatric Dose for Anxiety

ORAL:
12 years or older:

• Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
• Maintenance dose: 1 to 2 mg orally 2 to 3 times a day

• The daily dosage may vary from 1 to 10 mg/day.
• The dosage should be increased gradually when needed to help avoid adverse effects.
• When higher dosage is indicated, the evening dose should be increased before the daytime doses.
• Use of anxiolytic agents is typically not needed to treat anxiety/tension associated with the stress of everyday life.
• Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Uses:

• Management of anxiety disorders
• Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Pediatric Dose for Insomnia

ORAL:
12 years or older: 2 to 4 mg orally once a day at bedtime

Comments:

• For debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended.
• The dosage should be increased gradually when needed to help avoid adverse effects.
• Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Use: Management of insomnia

Renal Dose Adjustments

INJECTION:

• Frequent doses given over a relatively short period of time: Use with caution.
• Infrequent doses and/or doses given over a long period of time: No adjustment recommended.

ORAL: Use with caution.

Liver Dose Adjustments

INJECTION: No adjustment recommended.

ORAL:

• Mild to moderate liver dysfunction: Use with caution.
• Severe liver dysfunction: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Dose Adjustments

Doses should be reduced by 50% when coadministered with probenecid or valproate.

INJECTION: It may be necessary to increase the dose in female patients who are concomitantly taking oral contraceptives.

Precautions

US BOXED WARNINGS:
RISKS FROM CONCOMITANT USE WITH OPIOIDS:

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Recommendations:

• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• If a decision is made to use this drug concomitantly with opioids, monitor patients closely for respiratory depression and sedation.

ABUSE, MISUSE, AND ADDICTION:

• The use of benzodiazepines, including this drug, exposes users to risks of abuse, miscues, and addiction, which can lead to overdose or death.
• Abuse and misuse of benzodiazepines commonly the involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.

Recommendation:

• Before prescribing this drug and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

DEPENDENCE AND WITHDRAWAL REACTIONS:

• The continued use of benzodiazepines for several days to weeks may lead to clinically significant physical dependence.
• Although this drug is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of this drug may precipitate acute withdrawal reactions, which can be life-threatening.

Recommendation:

• Patients using this drug more frequently than recommended should gradually taper this drug to reduce the risk of withdrawal reactions.

INJECTION CONTRAINDICATIONS:

• Hypersensitivity to the active component, benzodiazepines, or to any of the ingredients (e.g., Benzyl alcohol, polyethylene glycol, propylene glycol)
• Intra-arterial use
• Patients with acute narrow-angle glaucoma
• Patients with sleep apnea syndrome
• Severe respiratory dysfunction EXCEPT those requiring relief of anxiety and/or reduced recall of events while being mechanically ventilated
• Use in premature infants

ORAL CONTRAINDICATIONS:

• Hypersensitivity to the active component, benzodiazepines, or to any of the ingredients
• Patients with acute narrow-angle glaucoma

Safety and efficacy of oral formulations have not been established in patients younger than 12 years.

Safety and efficacy of injection formulations have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• Oral concentrates: Solutions may be mixed with liquid or semi-solid foods.

Storage requirements:

• Injection: Protect from light; store in a refrigerator at 2 to 8 C
• Oral Concentrate: Store in a refrigerator at 2 to 8 C; discard after 90 days of opening
• Oral Solution: Store in a refrigerator at 2 to 8 C; protect from light
• Tablets: Store in a cool, dry place; protect from light

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• The manufacturer product information should be consulted.

General:

• This drug has not been shown to treat cardiovascular and/or gastrointestinal components of anxiety.

Monitoring:

• HEMATOLOGIC: Periodic blood counts, especially in patients on long-term therapy
• HEPATIC: Periodic liver function tests, especially in patients on long-term therapy
• NERVOUS SYSTEM: Sedation, especially within 1 hour of administration AND when given a parenteral formulation
• RENAL: Renal function, especially in older patients with decreased renal function
• RESPIRATORY: Respiratory function, especially in status epilepticus

Patient advice:

• This medicine may increase the risk of suicidal thoughts and behavior. Patients should be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Patients should report any behavior of concern to their healthcare provider as soon as possible.
• This drug may cause drowsiness, dizziness, and reduced alertness. Patients should not drive a car or operate dangerous machinery until they know how this drug affects them.
• Patients should avoid drinking alcohol or taking other drugs that may cause sleepiness or dizziness while taking this drug until they talk to their healthcare provider.
• Patients should be told to contact their healthcare provider before increasing/decreasing the dose or discontinuing treatment.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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