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Ambien (Zolpidem Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 AND ADMINISTRATION

The dose of Ambien should be individualized.

Dosage in adults

The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 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 normal subjects. The recommended dose of Ambien in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions].

Use with CNS depressants

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

Administration

The effect of Ambien may be slowed by ingestion with or immediately after a meal.

DOSAGE FORMS AND STRENGTHS

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

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

HOW SUPPLIED/STORAGE AND HANDLING

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
21695-211-15 bottle of 15
21695-211-30 bottle 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
21695-212-15 bottle of 15
21695-212-30 bottle of 30
21695-212-45 bottle of 45

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

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