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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

g spontaneous awakenings when patients had difficulty returning to sleep after waking in the middle of the night, provided they had at least four hours remaining in bed. Subjective time to fall back to sleep after a middle-of-the-night awakening was significantly shorter for Intermezzo 3.5 mg (38 minutes) compared to placebo (56 minutes).The most commonly observed adverse reactions (>1% ) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).(1)

In a sleep laboratory study, 82 adult patients aged 19 to 64 years (58 females, 24 males) were evaluated in a 3-period, 2-consecutive-night treatment period cross-over design. Patients were awakened four hours after bedtime, administered Intermezzo 3.5 mg, 1.75 mg, or placebo, were kept awake for 30 minutes before lights-out, and then allowed to return to sleep for four hours. As compared to placebo, patients taking Intermezzo had significantly shorter objective mean time to fall back asleep after the middle-of-the-night awakening (women taking 1.75 mg: 16 min vs. placebo: 28 min; men taking 3.5 mg: 13 min vs. placebo: 29 min).(1)

Use of Intermezzo in Elderly, in Hepatic Impairment, or with Concomitant CNS Depressants
Geriatric patients may be especially sensitive to the effects of zolpidem.  The recommended dose for elderly men and women over 65 years old is 1.75 mg taken only once per night if needed. The recommended dose for men and women with hepatic impairment or those taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with Intermezzo because of potentially additive effects. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

How to Take Intermezzo
Intermezzo is to be taken in bed when a patient wakes in the middle of the night and
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SOURCE Purdue Pharma L.P.
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