Usual Adult Dose for Insomnia

IM: 150 to 200 mg IM ONCE
IV:

• Initial dose: 100 mg via IV injection ONCE
• Maintenance dose: 100 to 500 mg via IV Injection
• Note: The maintenance dose includes the initial dose; additional doses (if needed) should be given in increments after at least 1 minute following the initial dose.
• Maximum dose: 500 mg/day

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• The IV injection rate should not exceed 50 mg/min.
• At least 1 minute should elapse between doses to determine the full effect of IV treatment; additional small increments of the drug may be given (up to a total dose of 200 to 500 mg).
• The initial IV dose was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Usual Adult Dose for Sedation

IM: 150 to 200 mg IM ONCE
IV:

• Initial dose: 100 mg via IV injection ONCE
• Maintenance dose: 100 to 500 mg via IV Injection
• Note: The maintenance dose includes the initial dose; additional doses (if needed) should be given in increments after at least 1 minute following the initial dose.
• Maximum dose: 500 mg/day

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• The IV injection rate should not exceed 50 mg/min.
• At least 1 minute should elapse between doses to determine the full effect of IV treatment; additional small increments of the drug may be given (up to a total dose of 200 to 500 mg).
• The initial IV dose was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Usual Adult Dose for Status Epilepticus

IM: 150 to 200 mg IM ONCE
IV:

• Initial dose: 100 mg via IV injection ONCE
• Maintenance dose: 100 to 500 mg via IV Injection
• Note: The maintenance dose includes the initial dose; additional doses (if needed) should be given in increments after at least 1 minute following the initial dose.
• Maximum dose: 500 mg/day

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• The IV injection rate should not exceed 50 mg/min.
• At least 1 minute should elapse between doses to determine the full effect of IV treatment; additional small increments of the drug may be given (up to a total dose of 200 to 500 mg).
• The initial IV dose was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Usual Pediatric Dose for Insomnia

Adequate, well-controlled studies have not been performed in pediatric patients; published case reports and other studies in pediatric patients supports safety and efficacy. Manufacturer suggested dosing:
IM: 2 to 6 mg/kg IM ONCE

• Maximum dose: 100 mg

IV: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• An initial IV dose of 100 mg via IV injection ONCE was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Usual Pediatric Dose for Sedation

Adequate, well-controlled studies have not been performed in pediatric patients; published case reports and other studies in pediatric patients supports safety and efficacy. Manufacturer suggested dosing:
IM: 2 to 6 mg/kg IM ONCE

• Maximum dose: 100 mg

IV: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• An initial IV dose of 100 mg via IV injection ONCE was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Usual Pediatric Dose for Status Epilepticus

Adequate, well-controlled studies have not been performed in pediatric patients; published case reports and other studies in pediatric patients supports safety and efficacy. Manufacturer suggested dosing:
IM: 2 to 6 mg/kg IM ONCE

• Maximum dose: 100 mg

IV: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

• After administration of a hypnotic IM injection dose, vital signs should be monitored.
• An initial IV dose of 100 mg via IV injection ONCE was predicted for patients weighing 70 kg.
• When treating insomnia, this drug typically loses effectiveness for sleep induction and maintenance after 2 weeks.

Uses:

• Anticonvulsant at anesthetic doses in the emergency control of certain acute convulsive episodes (e.g., associated with cholera, eclampsia, meningitis, status epilepticus, tetanus, topic reactions to local anesthetic or strychnine)
• Preanesthetic
• Sedative
• Short-term treatment of insomnia (as a hypnotic)

Renal Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Dose Adjustments

Patients who are elderly and/or debilitated: The dose should be reduced because these patients may be more sensitive to barbiturates.

Withdrawal regimens: Cautious and gradual withdrawal of this drug should be performed over an extended period. The manufacturer product information should be consulted regarding recommendations for specific dosing regimens.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, known barbiturate sensitivity, or to any of the ingredients
• Patients with a history of latent/manifest porphyria

Safety and efficacy of this drug have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:

• Parenteral administration should be reserved for situations where oral formulations would be impossible or impractical.
• Patients receiving IV injections should be closely monitored, and resuscitation and artificial ventilation equipment should be available.

IV compatibility:

• IV solutions should not be admixed with other drugs or solutions.

General:

• This drug should be given under the direction of a healthcare provider.
• Dosing should consider the patient's age, status, and weight.

Monitoring:

• CARDIOVASCULAR: Blood pressure and cardiac function, especially in patients receiving IV injections
• HEMATOLOGIC: Periodic blood counts, especially in patients on long-term treatment
• HEPATIC: Periodic liver function tests, especially in patients on long-term treatment
• RENAL: Periodic renal function tests (e.g., respiration rate), especially in patients on long-term treatment and in those receiving IV injections

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.