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Ambien CR (Zolpidem Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).

The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies].

DOSAGE AND ADMINISTRATION

The dose of Ambien CR should be individualized.

Dosage in adults

The recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR dose should not exceed 12.5 mg per day.

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 normals. The recommended dose of Ambien CR in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions].

Use with CNS depressants

Dosage adjustments may be necessary when Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions].

Administration

Ambien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.

DOSAGE FORMS AND STRENGTHS

Ambien CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored.

Ambien CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side.

Ambien CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side.

HOW SUPPLIED/STORAGE AND HANDLING

Ambien CR 6.25 mg tablets are composed of two layers [Layers are covered by the coating and are indistinguishable.] and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:

NDC Number      Size
21695-319-30      bottle of 30

Ambien CR 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with A~ on one side and supplied as:

NDC Number      Size
21695-213-15      bottle of 15
21695-213-30      bottle of 30

Store between 15°–25° C (59°–77°F). Limited excursions permissible up to 30° C (86°F)

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