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Ambien (Zolpidem)

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Description

Ambien (Zolpidem)

Ambien (Zolpidem) is a medication primarily used for the short term treatment of sleeping problems. Guidelines recommend that it be used only after counseling and behavioral changes have been tried. It decreases the time to sleep onset by about 15 minutes and at larger doses helps people stay asleep longer. It is taken by mouth and is available in conventional tablets or sublingual tablets and oral spray.

Indications & Dosage

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.

Dosage for 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. The total dose of AMBIEN should not exceed 10 mg once daily immediately before bedtime. Ambien should be taken as a single dose and should not be readministered during the same night.

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. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime. Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy

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.

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:

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