To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: DG DISPATCH - APPS: Provigil (Modafinil) Enhances Performance and Alertness In Healthy, Sleep-Deprived Individuals URL: http://www.pslgroup.com/dg/1D6A9E.htm Doctor's Guide June 21, 2000
By Jill Stein Special to DG News LAS VEGAS, NV -- June 21, 2000 -- The new wakefulness-promoting agent Provigil (modafinil) consistently improves performance and alertness in healthy individuals who are sleep-deprived, including military personnel and shift workers, according to results presented at the 14th Annual Meeting of the Associated Professional Sleep Societies (APSS). John A. Caldwell, PhD, with the US Army Aeromedical Research Laboratory at Fort Rucker, Alabama, presented data from a double-blind, placebo-controlled, crossover study of six helicopter pilots using a flight simulator. The helicopter pilots were exposed to two 40-hour periods of continuous wakefulness separated by one night of recovery sleep. In one of the two sleep deprivation periods, three doses of modafinil (200 mg each) were administered; placebo was given during the other deprivation period. Testing included performance on six flight maneuvers, electroencephalographic examinations, mood questionnaires and cognitive evaluations. Pilots receiving three 200 mg doses of modafinil had superior scores on tests of performance and physiological arousal than they did while on placebo and also had improved self-ratings of vigor, energy, alertness, talkativeness, and confidence, said Dr. Caldwell, who is Director of Sustained Operations Research. The most common side effects related to the active treatment were jitteriness (or nervousness/racing heart), vertigo and nausea. These side effects may prove to be related to the high (600 mg) dose and may have been aggravated by the motion base simulator, he suggested. At a symposium held in conjunction with the APSS, Nancy Wesensten, PhD, with the Walter Reed Army Institute of Research in Washington DC, reported the results of a study that compared three doses of modafinil (100 mg, 200 mg, or 400 mg) to high-dose caffeine (600 mg) and placebo in 50 healthy volunteers undergoing prolonged sleep deprivation. The primary efficacy measures were performance and alertness over a 54-hour period of sustained/continuous work, with no opportunity to sleep. In the trial, the active drug or placebo was administered over 40 hours of sleep deprivation. Alertness, mood, performance and safety were evaluated during a 14-hour period after treatment. Results showed that 200 mg and 400 mg of modafinil improved alertness and performance, Dr. Wesensten, a research psychologist, reported. In addition, the 400 mg dose was as consistently effective as high doses of caffeine but was associated with fewer side effects. The most common drug-related side effects were nausea/gastrointestinal distress and jitteriness. Subjects receiving caffeine complained of these side effects along with disorientation and vomiting. Charles A. Czeisler, MD, Co-Director of the Division of Sleep Medicine at the Harvard Medical School in Boston, Massachusetts, reported that modafinil provides similar benefits to shift workers as it does to military personnel. His group monitored sleep and wake times in 16 healthy subjects for 24 hours per day for four days and included one 28-hour period of sleep deprivation. Trial participants were randomized to treatment with either 200 mg of modafinil or placebo. Modafinil improved alertness and performance compared to placebo, as measured by standard, validated vigilance scales, and did not interfere with subsequent daytime sleep opportunities. The most common side effects related to modafinil treatment were nausea and headache. Related Link: Provigil (modafinil). --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.