Ambien
INDICATIONS
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.
HOW SUPPLIED
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:
| NDC Number | Size |
| 0024-5401-31 | bottle of 100 |
| 0024-5401-34 | carton of 100 unit dose |
| 0024-5401-50 | bottle of 500 |
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 |
Store at controlled room temperature 20°– 25°C (68° - 77°F).
sanofi-aventis U.S. LLC Bridgewater, NJ 08807. February 2008. FDA revision date: 5/7/2008
Generic Name: Zolpidem Tartrate
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