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Dosing and Administration

EDLUAR sublingual tablets are available in a 5-mg or 10-mg strength, and the once-daily dose should not exceed 10 mg:1

Dosing2
Patients Strengths
Adults* 10 mg
Elderly or debilitated patients 5 mg

An EDLUAR sublingual tablet should be placed under the tongue, where it will disintegrate, and it should be taken immediately before bedtime.‡2

Administration2

Do Remind Your Patients To:

Remind Your Patients, Do NOT:

EDLUAR is non-AB rated and should not be substituted.3

References: 1, 2 EDLUAR [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2009.

3 Orange Book: approved drug products with therapeutic equivalence evaluations.

http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed August 4, 2009.

* EDLUAR is not recommended for use in children. Safety and effectiveness of EDLUAR have not been established in pediatric patients below the age of 18.

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. Therefore, the recommended dose of EDLUAR in these patient populations is 5 mg once daily immediately before bedtime. These patients should be closely monitored. Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken with patients who have compromised respiratory function and chronic obstructive pulmonary disease. EDLUAR should be used with caution in patients with signs or symptoms of depression. The least amount of drug that is feasible should be prescribed for the patient at any one time.

Patients should be counseled to take EDLUAR right before they get in bed and only when they are able to stay in bed a full night (7-8 hours) before being active again.

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