Transcept Pharmaceuticals Announces Broadened Intermezzo® Commercialization Strategy Including Initiation Of A Direct To Consumer Advertising Campaign By Purdue Pharma

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, and were kept awake for 30 minutes before lights-out. As compared to placebo, Intermezzo significantly decreased objective mean time to fall back asleep after a 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).

How to Take IntermezzoThe recommended and maximum dose of Intermezzo for male adults is 3.5 mg and for female adults is 1.75 mg, administered as a sublingual tablet only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for men and women are different because women clear zolpidem from the body at a lower rate than men.

The recommended dose for elderly men and women over 65 years old or patients with hepatic impairment is 1.75 mg. The recommended dose for men and women who are 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.

Intermezzo is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Intermezzo should only be taken if the patient has at least four hours of bedtime remaining before the planned time of waking.

Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Intermezzo should not be administered with or immediately after a meal. The blister should be removed from the pouch just prior to dosing.

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