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Indications and Usage for Ambien

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.

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.

Ambien Dosage and Administration

Dosage in Adults

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Ambien should not exceed 10 mg once daily immediately before bedtime.

Insomnia Treatment with Non-Benzodiazepines Ambien, Lunesta & Sonata

Insomnia Treatment with Non-Benzodiazepines Ambien, Lunesta & Sonata

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

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.

Use with CNS Depressants

Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects.

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.