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Data Presented at the American Psychiatric Association Annual Meeting Supports Gender-Specific Dosing of Intermezzo® (zolpidem tartrate) Sublingual Tablets CIV
Date:5/8/2012

PHILADELPHIA, May 8, 2012 /PRNewswire/ -- The new prescription sleep aid Intermezzo (zolpidem tartrate) sublingual tablet CIV is the first and only prescription sleep aid approved by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep, and the patient has at least four hours of bedtime remaining before the planned time of waking. Intermezzo has gender-specific dosing (1.75 mg for adult women and 3.5 mg for adult men) taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo 1.75 mg is also the recommended dose for men and women over 65 years of age, patients with hepatic impairment, or patients taking concomitant CNS depressants.

In the double-blind, placebo-controlled, cross-over pharmacokinetic study in healthy volunteers, Intermezzo doses of 1.0 mg, 1.75 mg, and 3.5 mg were administered on two consecutive days to 11 women and 13 men. At the same dose, the plasma levels of zolpidem tartrate in women were approximately 45 percent higher than in men. The study found that women taking a 3.5 mg dose cleared the drug at a slower rate than men taking 3.5 mg (2.7 ml/min/kg vs. 4.00 ml/min/kg, respectively).

"Given that women clear the active ingredient in Intermezzo at a lower rate than men, the results of the study support a recommended lower dosage of Intermezzo for women and a higher dosage for men," said study co-author Thomas Roth, Ph.D., Director of Sleep Medicine at Henry Ford Hospital in Detroit.

Intermezzo was approved by the FDA in November 2011 and is available nationwide in spearmint-flavored sublingual tablets that are placed under the tongue and allowed to disintegrate completely before swallowing. Intermezzo contains a bicarbonate-carbonate buffer. On average, Intermezzo is rapidly absorbed in both genders, achieving peak mean plasma levels of zolpidem in
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SOURCE Purdue Pharma L.P.
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