Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc
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Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc Drugs
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2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 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 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 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 Zolpidem Tartrate Extended-Release Tablets should not exceed 12.5 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 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 Zolpidem Tartrate Extended-Release Tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when Zolpidem Tartrate Extended-Release Tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
Zolpidem Tartrate Extended-Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed by ingestion with or immediately after a meal.
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