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). (See Clinical Pharmacology: Controlled trials supporting safety and efficacy.)

The clinical trials performed in support of efficacy were both 3 weeks in duration, although the final formal assessments of sleep latency and maintenance were performed after 2 weeks of treatment.

DOSAGE AND ADMINISTRATION

The dose of Ambien CR should be individualized.

Ambien CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral 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.

The recommended dose of Ambien CR for adults is 12.5 mg immediately before bedtime.

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Ambien CR in these patients is 6.25 mg immediately before bedtime (see Precautions ).

HOW SUPPLIED

Ambien CR 6.25 mg tablets are composed of two layers [Layers are covered by the coating and are indistinguishable. The tablets are to be swallowed whole and should not be crushed, chewed, or divided.] and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:

NDC Number       Size

0024-5501-31       bottle of 100
0024-5501-50       bottle of 500
0024-5501-10       carton of 30 unit dose
0024-5501-34       carton of 100 unit dose

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

0024-5521-31       bottle of 100
0024-5521-50       bottle of 500
0024-5521-10       carton of 30 unit dose
0024-5521-34       carton of 100 unit dose

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