Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies].

The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Dosage in Adults

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of Edluar should not exceed 10 mg once daily immediately before bedtime.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Special Populations

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. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].

Use with CNS Depressants

Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].

Administration

The effect of Edluar may be slowed by ingestion with or immediately after a meal.

Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

Dosage Forms And Strengths

Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are not scored.

Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed V on one side.

Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed X on one side.

Storage And Handling

Edluar is supplied as sublingual tablets in two dosage strengths: Tablets are not scored.

Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed V on one side and supplied as:

The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters.

Edluar 10 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed X on one side and supplied as:

The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Store at controlled room temperature 20-25°C (68-77°F). Protect from light and moisture.

Manufactured by: Recipharm Stockholm AB, Sweden for Meda Pharmaceuticals Inc. Distributed by: Meda Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, NJ 08873-4120. Rev. 04/2013

Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.