Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see CLINICAL STUDIES].

The clinical trials performed 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

The dose of Ambien should be individualized.

The recommended dose for adults is 10 mg immediately before bedtime.

Special Populations

Elderly or debilitated patients may be especially sensitive to the effects of Ambien (zolpidem tartrate). Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see WARNINGS and PRECAUTIONS].

Administration with CNS depressants:

Downward dosage adjustment may be necessary when Ambien is administered with agents having known CNS-depressant effects because of the potentially additive effects [see WARNINGS and PRECAUTIONS].

Maximum daily dose

The total Ambien dose should not exceed 10 mg per day.

Dosage Forms And Strengths

Ambien is available in 5 mg and 10 mg strength tablets for oral administration.

Ambien 5 mg tablets are capsule-shaped, pink, film coated, with, AMB 5 debossed on one side and 5401 on the other. The 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other. Tablets are not scored.

Ambien 5 mg tablets are capsule-shaped, pink, film coated, with, AMB 5 debossed on one side and 5401 on the other and supplied as:

NDC Number        Size

0024-5401-31        bottle of 100
0024-5401-34        carton of 100 unit dose
0024-5401-50        bottle of 500
0024-5401-10        Ambien PAK™ unit-of-use blister of 30

Ambien 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:

NDC Number        Size

0024-5421-31        bottle of 100
0024-5421-34        carton of 100 unit dose
0024-5421-50        bottle of 500
0024-5421-10        Ambien PAK™ unit-of-use blister of 30

Storage and handling

Store at controlled room temperature 20°–25° C (68°–77°F).

Sanofi-Aventis U.S. LLC Bridgewater, NJ 08807
Revised March 2007B
Copyright, sanofi-aventis U.S. LLC 2007
FDA rev date: 3/28/2007

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