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| |  Serzone Is Associated with Greater Improvement Of Sleep Quality -- Study PRINCETON, N.J., May 19, 1997 -- Studies presented during the American Psychiatric Association (APA) meeting held yesterday show Serzone(R) (nefazodone HCl) to be superior to Prozac(R) (fluoxetine HCl) in increasing sleep efficiency and providing better sleep quality for people suffering from depression. Data from these studies are the most comprehensive to date on the effects of nefazodone and fluoxetine on sleep disturbance, one of the most common symptoms of depression. The results of identical, multi-site, eight-week studies were announced at a briefing during the APA meeting in San Diego. The randomized, double-blind studies compared the objective and subjective effects of nefazodone and fluoxetine on sleep of depressed patients. The data were presented by investigators, A. John Rush, M.D., University of Texas Southwestern Medical Center in Dallas, J. Christian Gillin, M.D., University of California, Veterans Affairs Medical Center at San Diego, as well as Michael Thase, M.D., University of Pittsburgh, an expert on sleep and depression. The first study, "A Multi-Center Double-Blind Comparison of the Effects of Nefazodone and Fluoxetine on Sleep Architecture and Quality of Sleep in Depressed Patients," was lead by Roseanne Armitage, Ph.D., associate professor of Psychiatry and Psychology at the University of Texas Southwestern Medical Center in Dallas. Dr. Armitage showed that while treatment with nefazodone and fluoxetine resulted in comparable antidepressant response rates, the sleep effects of nefazodone were quite distinct from fluoxetine. This study found that treatment with nefazodone increased sleep efficiency and decreased nighttime awakenings. In contrast, nighttime awakenings increased with fluoxetine. These results will be published in the June issue of the Journal of Clinical Psychopharmacology. The findings were consistent with the results of a second study. The second study, "A Comparison of Nefazodone and Fluoxetine on Mood and on Objective, Subjective and Clinical-Related Measures of Sleep in Depressed Patients: A Double-Blind, 8-Week Clinical Trial," was conducted at the University of California, Veterans Affairs Medical Center at San Diego, by J. Christian Gillin, M.D., professor of Psychiatry, et al. Dr. Gillin revealed that nefazodone significantly improved a number of sleep measures to a greater extent than fluoxetine including insomnia and early awakenings. The study will be published in the May issue of the Journal of Clinical Psychiatry. The combined results of these two studies and a third identical study were reported in a pooled analysis, "Comparative Effects of Nefazodone and Fluoxetine on Sleep in Outpatients with Major Depressive Disorder," conducted by A. John Rush, M.D., professor and vice chairman for Research, Department of Psychiatry, University of Texas Southwestern Medical Center in Dallas, et al. Although treatment with nefazodone and fluoxetine resulted in comparable antidepressant response rates, four significant differences were noted: -- Nefazodone increased (while fluoxetine reduced) sleep efficiency. The investigators concluded that improving sleep quality may have positive consequences for treating patients with depression for several reasons, including improvement of patient compliance with treatment. Moreover, the need for concomitant treatment with sedative/hypnotic agents may be decreased in those individuals with improved sleep quality and consequently have beneficial effects on pharmacoeconomic outcome. The most common adverse events associated with nefazodone treatment in placebo-controlled trials (reported at greater than 5% and significantly different from placebo) include asthenia, dry mouth, nausea, constipation, somnolence, dizziness, lightheadedness, confusion and visual symptoms. Co-administration with Seldane(R) (terfenadine), Hismanal(R) (astemizole), Propulsid(R) (cisapride) is contraindicated. Co-administration with monoamine oxidase inhibitors (MAOIs) is not recommended. Dosage reductions of triazolam and alprazolam are recommended when used with nefazodone. Since any psychoactive drug may impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain the nefazodone therapy does not adversely affect their ability to engage in such activities. The studies were sponsored by Bristol-Myers Squibb as part of its ongoing commitment to research. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products.
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