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Edluar (Zolpidem Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Edluar (zolpidem tartrate sublingual tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

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 [ see Clinical Studies (14) ].

DOSAGE AND ADMINISTRATION

The dose of Edluar should be individualized.

Dosage in adults

The recommended dose for Edluar for adults is 10 mg once daily immediately before bedtime. The total Edluar daily dose should not exceed 10 mg.

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 (5.6) ].

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 (5.5) ].

Administration

The effect of Edluar may be slowed by ingestion with or immediately after a meal. Edluar should not be given 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.

HOW SUPPLIED/STORAGE AND HANDLING

How supplied

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:

NDC NumberSize
0037-6050-30blister pack of 30

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:

NDC NumberSize
0037-6010-30blister pack of 30

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

Storage and handling

Store at controlled room temperature 20-25C (68-77F). Protect from light and moisture.

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