Purdue Pharma launches Intermezzo for middle-of-the-night insomnia

Purdue Pharma L.P. announced today that Intermezzo^® (zolpidem tartrate) sublingual tablet CIV is now available in 1.75 mg and 3.5 mg dosage strengths by prescription in retail pharmacies nationwide. Intermezzo is the first and only prescription sleep aid approved for middle-of-the-night dosing, and should only be taken once per night in bed, as needed, when a patient wakes up in the middle of the night and has difficulty returning to sleep. Intermezzo is not indicated for use when a patient has fewer than four hours of bedtime remaining before the planned time of waking.

"Patients with middle-of-the-night insomnia now have a treatment option approved for dosing in the middle of the night," said sleep expert, Professor of Family Medicine and Associate Editor of the Delaware Medical Journal Joseph Lieberman M.D., M.P.H. "The availability of Intermezzo is an important treatment option for patients who suffer with this form of insomnia and want a treatment that they can use as needed to fall back to sleep in the middle of the night when they have difficulty returning to sleep."

Intermezzo, which was approved by the U.S. Food and Drug Administration in November 2011, is available 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, with a mean time to maximum plasma levels across studies that ranged from about 35 minutes to about 75 minutes. The recommended and maximum dose of Intermezzo is 1.75 mg for female adults and 3.5 mg for male adults, taken only once per night as needed 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. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men. For optimal effect, Intermezzo should not be administered with or immediately after a meal. 

"We are committed to helping patients affected by insomnia characterized by middle-of-the-night awakenings followed by difficulty falling back to sleep by introducing innovative therapies like Intermezzo and offering the educational tools and information that support safe and appropriate use," said John H. Stewart, president and CEO of Purdue Pharma L.P. "We are confident that healthcare professionals will find Intermezzo to be a valuable therapeutic option."