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Ambien CR

"Sleep disorder drugs (hypnotic and sedative drugs) overview

Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...

Ambien CR

Ambien CR

INDICATIONS

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 (zolpidem tartrate) should be individualized.

Dosage in adults

The recommended dose of Ambien CR (zolpidem tartrate) for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR (zolpidem tartrate) 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 (zolpidem tartrate) 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 (zolpidem tartrate) is combined with other CNS depressant drugs because of the potentially additive effects [seeWARNINGS AND PRECAUTIONS].

Administration

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

HOW SUPPLIED

Dosage Forms And Strengths

Ambien CR (zolpidem tartrate) 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 (zolpidem tartrate) 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side. Ambien CR (zolpidem tartrate) 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side.

Ambien CR (zolpidem tartrate) 6.25 mg tablets are composed of two layers* 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 (zolpidem tartrate) 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)

*Layers are covered by the coating and are indistinguishable.

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807. Rev: Apr 2010

Last reviewed on RxList: 5/10/2010
This monograph has been modified to include the generic and brand name in many instances.

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Ambien CR - User Reviews

Ambien CR User Reviews

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