Ambien
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Ambien
INDICATIONS
Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien (zolpidem tartrate) 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 (zolpidem tartrate) should be individualized.
Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien (zolpidem tartrate) 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 (zolpidem tartrate) 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 (zolpidem tartrate) is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].
Administration
The effect of Ambien (zolpidem tartrate) may be slowed by ingestion with or immediately after a meal.
HOW SUPPLIED
Dosage Forms And Strengths
Ambien (zolpidem tartrate) is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.
Ambien (zolpidem tartrate) 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.
Ambien (zolpidem tartrate) 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 (zolpidem tartrate) 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 |
Ambien (zolpidem tartrate) 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 |
Store at controlled room temperature 20°–25°C (68°–77°F).
sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Rev: 4/2010
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Ambien Information
Ambien - User Reviews
Ambien User Reviews
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Report Problems to the Food and Drug Administration
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