The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than four hours of bedtime remaining; if a higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients four hours after the 1.75 mg dose in women, and after the 3.5 mg dose in men, such that a potential negative effect on driving cannot be completely excluded.
Additional Important Safety Information is presented below.
About IntermezzoIntermezzo is the first and only prescription sleep aid approved 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 four hours of bedtime remaining before the planned time of waking. Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
The safety and efficacy of Intermezzo was evaluated in two randomized, double-blind, placebo-controlled studies in patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening. Patients met the diagnosis for primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) and had at least 3 prolonged middle-of-the-night awakenings per week of at least 30 minutes in duration.In a four-week outpatient study in 295 adult patients aged 18 to 64 years (201 females, 94 males), Intermezzo 3.5 mg or placebo was taken on an as-needed basis following 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%).
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