The US Food and Drug Administration (FDA) has approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Intermezzo is the first and only prescription sleep aid indicated for dosing in the middle of the night to treat this form of insomnia. The drug is formulated as a sublingual tablet containing a bicarbonate-carbonate buffer and is rapidly absorbed in both women and men.
The recommended dose of Intermezzo for nonelderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. These recommended doses are specific to each gender because women clear zolpidem from the body at a lower rate than men. The 1.75 mg dose is recommended for patients over the age of 65. The recommended doses of other FDA-approved zolpidem products range between 5 mg and 12.5 mg and are indicated for bedtime use.
The safety and efficacy of Intermezzo were evaluated in two placebo-controlled studies for the treatment of patients with insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. In both a sleep laboratory study and an outpatient study, treatment with Intermezzo after a middle-of-the-night awakening helped patients return to sleep significantly faster than placebo. The most commonly reported adverse reactions in these studies were headache, nausea, and fatigue.
Transcept has agreed to FDA postmarketing commitments including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment in accordance with the Pediatric Research Equity Act (PREA).
Transcept and Purdue are parties to a collaboration agreement for the development and commercialization of Intermezzo in the United States. Under this collaboration agreement, Purdue has until December 8, 2011, to notify Transcept whether it will proceed with the commercialization of Intermezzo.