Usual Adult Dose for Insomnia

Initial dose: 0.25 mg orally once a day at bedtime
Maintenance dose: 0.125 to 0.25 mg orally once a day at bedtime
Maximum dose: 0.5 mg/day
Duration of therapy: 7 to 10 days

Comments:

• Failure to respond after 7 to 10 days may suggest a primary psychiatric and/or medical illness that requires further evaluation.
• Use of this drug for more than 2 to 3 weeks requires complete reevaluation of the patient.

Usual Geriatric Dose for Insomnia

Initial dose: 0.125 mg orally once a day at bedtime
Maintenance dose: 0.125 to 0.25 mg orally once a day at bedtime
Maximum dose: 0.25 mg/day
Duration of therapy: 7 to 10 days

Comments:

• Failure to respond after 7 to 10 days may suggest a primary psychiatric and/or medical illness that requires further evaluation.
• Use of this drug for more than 2 to 3 weeks requires complete reevaluation of the patient.
• The lowest effective dose should be used to minimize the potential for oversedation.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Debilitated patients or patients with low body weight:

• Initial dose: 0.125 mg orally once a day at bedtime
• Maintenance dose: 0.125 to 0.25 mg orally once a day at bedtime
• Maximum dose: 0.25 mg/day

• Treatment should not be abruptly ceased, particularly in patients with a history of seizure.
• Tapering of the dose is recommended in any patient taking more than the lowest dose for longer than a few weeks.
• Providers should consider pausing the taper OR increasing the dose to the previously tapered level if withdrawal reactions occur.

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.

• 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.
• Follow patients for signs and symptoms of respiratory depression and sedation.

• The use of benzodiazepines, including this drug, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and 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 this drug and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

• The continued use of benzodiazepines, including this drug, 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 this drug 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 this drug or reduce the dosage.

• Hypersensitivity to the active component, other benzodiazepines, or to any of the ingredients
• Use with strong CYP450 3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir, nefazodone, ritonavir)

Dialysis

Data not available

Other Comments

Administration advice:

• Doses should be administered immediately before bedtime.
• Doses should not be taken where a full night's sleep and clearance of the drug from the body are not possible before the patient would need to be active and functional, e.g., overnight flights lasting less than 7 to 8 hours.

• Prescriptions for this drug should be written for short-term use; it should not be prescribed in quantities that exceed a 1-month supply.
• Older patients are more susceptible to dose-related side effects such as drowsiness, dizziness, lightheadedness, and amnesia.
• The lowest effective dose should be used.

• NERVOUS SYSTEM: Anterograde amnesia, drowsiness, dizziness
• OTHER: Withdrawal side effects, e.g., rebound insomnia, tolerance, dependence
• PSYCHIATRIC: Complex behaviors such as "sleep-driving", anxiety, emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

• Patients should tell their healthcare provider about all of the medicines that they take, including prescription and non-prescription medicines.
• Patients should be told to contact their healthcare provider before increasing/decreasing the dose or discontinuing treatment.
• Patients should be instructed to immediately report "sleep driving," other complex behaviors, and any new/worsening signs/symptoms of depression.
• Inform patients that this drug may cause decreased coordination, dizziness, and/or drowsiness, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.