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"One significant challenge in trying to help insomnia patients return tosleep after a middle-of-the-night awakening is that the most commonlyprescribed bedtime medications are not designed to be taken as needed in themiddle of the night without risking significant drowsiness the following day,"said Thomas Roth, Ph.D., Chief of Sleep Medicine, Henry Ford Hospital SleepDisorders and Research Center in Detroit and principal investigator in thisstudy. "The only recourse to date for patients has been either to try topredict what nights they will awaken, or to take sleep medication every nightat bedtime. Studies of Intermezzo(R) show promise in offering the firstviable, 'use only when needed' option for treating awakenings in the middle ofthe night when they occur."
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Intermezzo(R): Rapid bioavailability despite a lower dose
In the pharmacokinetic comparison study presented at APSS, 36 healthysubjects between the ages of 19 and 64 were randomized to receive either a3.5 mg. Intermezzo(R) sublingual lozenge or a 10 mg. Ambien(R) tabletfollowing an overnight fast. Bioavailability assessments began prior todosing and continued for eight hours. Although Ambien(R) doses wereapproximately three times higher than those of Intermezzo(R), overallbioavailability at 5 minutes, 10 minutes and 20-minutes was significantlyhigher for Intermezzo 3.5 mg compared to Ambien(R) 10 mg. In a previousclinical sleep laboratory study, Intermezzo(R) 1.75 mg and 3.5 mg demonstrateda statistically significant improvement in latency to sleep onset vs. placebo;these are the lowest doses of zolpidem ever shown to be statisticallyeffective vs. placebo in inducing sleep.
Another of the study's authors, Andrew Krystal, M.D., Associate Professorand Director of the Duke Clinic Sleep Laboratory, commented, "TheIntermezzo(R) sublingual delivery system appears to markedly increase theearly uptake of zolpidem. Combining early bioavailability with a low dose mayoffer patients who wake up in the middle of the night help in returning tosleep while potentially avoiding next day residual effects."
MOTN Awakenings: Redefining Insomnia
Middle-of-the-night (MOTN) or nocturnal awakenings have been reported tobe one of the most common sleep problems, affecting approximately one-third ofthe adult population. According to a recent epidemiological study ("Nocturnalawakenings and comorbid disorders in the American general population" --Journal of Psychiatric Research [in press], Maurice M. Ohayon, MD, DSc, PhD.),nocturnal awakenings are the most frequently reported insomnia symptom in thegeneral population, with 35 percent of Americans experiencing awakenings atleast three times per week and 23 percent waking up at least once every night.Ninety percent of the MOTN insomnia population report that their pattern ofawakenings persists for at least six months and 50 percent report suchinsomnia problems lasting more than 5 years. Currently, there is no approvedPRN ("use only when needed") treatment for MOTN insomnia.
"The prevalence and impact of nocturnal awakenings may
