Usual Adult Dose for Insomnia

Initial dose: 7.5 mg orally once a day at bedtime
Maintenance dose: 7.5 to 15 mg orally once a day at bedtime

Comments:

• Prolonged administration is not recommended.
• The dose may be increased to 15 mg orally at bedtime if necessary for efficacy.
• The lowest effective dose should be used as adverse effects are dose related.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly and/or debilitated patients: Start at the lower end of the dosing range and observe closely.

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/symptoms of respiratory depression and sedation.

Dialysis

Data not available

Other Comments

General:

• Efficacy was established in placebo-controlled clinical studies performed in patients with acute and chronic insomnia over 5 nights.
• Sustained efficacy in patients with chronic insomnia was established in a polysomnographic study over 28 nights.

• Patients should be instructed to seek medical attention if hypersensitivity reactions occur.
• Patients should be counseled to report new/unusual changes in thinking or behavior or worsening of depression.
• Advise patients of next-day impairment, even in the absence of symptoms; patients should be cautioned that impairment may persist for several days following discontinuation.
• Patients and caregivers of those who are taking concomitant opioid therapy should be told to immediately report profound central nervous system or respiratory depression.