Drug only helps slightly to keep shift workers awake at night
http://www.100md.com
《英国医生杂志》
Treatment with modafinil, recently approved by the US Food and Drug Administration for treatment of the extreme sleepiness of patients with shift work sleep disorder, reduced this symptom and produced a small but significant improvement in performance in a randomised placebo controlled study ( New England Journal of Medicine 2005;353: 476-86). Yet measured levels of performance were much lower than what such patients need to function at a normal level, and more effective therapies are required, the authors conclude.
Members of the US Modafinil in Shift Work Sleep Disorder Study Group did the study between December 2001 and September 2002. Of 4533 shift workers pre-screened, 204 received the drug and 153 completed the study.
As many as 10% of shift workers in industrialised nations have insomnia or excessive sleepiness
Credit: MARCIO JOSE SANCHEZ/AP/EMPICS
As many as 20% of workers in industrialised nations are shift workers and as many as 10% of these have insomnia or excessive sleepiness and are at increased risk from peptic ulcers, coronary heart disease, insulin resistance, depression, sleepiness related unintentional injury, and curtailed social and family activities. Many of these people work in health care and the transportation industries.
The study found that treatment with the drug resulted in a modest improvement from baseline in what is called night time sleep latency—the interval between the time a person attempts to fall asleep and the onset of sleep. The test was done as an objective measure of sleep tendency during the night, when these patients normally work. Mean sleep latency was longer at night in the group taking modafinil—by 1.7 (standard error of the mean 0.4) minutes v 0.3 (0.3) minutes (P=0.002)—so their sleep tendency during their night work hours was reduced. Patients receiving modafinil also had reduced frequency and duration of attention lapse during night time performance testing on the Psychomotor Vigilance Test (change from baseline, a reduction in lapse frequency of 2.6 compared with an increase of 3.8, P<0.001). Proportionally fewer patients reported having had or nearly having had unintentional injuries while commuting home (29% v 54%; P<0.001). Patients treated with modafinil continued to have excess sleepiness and impaired performance at night, however.
An editorial accompanying the article said that modafinil may yet be shown to be an effective and safe adjunct to comprehensive strategies for shift work sleep disorder (p 519).
Brian Murray, a neurologist specialising in sleep medicine at the University of Toronto and Sunnybrook and Women's College Hospital, commented that the dose used in the study (200 mg) is sometimes doubled in treating narcolepsy or other disorders "so it's possible they could find more of an effect with a larger dose or other strategies. we don't think at this point that the medications can replace the need for sleep."(David Spurgeon)
Members of the US Modafinil in Shift Work Sleep Disorder Study Group did the study between December 2001 and September 2002. Of 4533 shift workers pre-screened, 204 received the drug and 153 completed the study.
As many as 10% of shift workers in industrialised nations have insomnia or excessive sleepiness
Credit: MARCIO JOSE SANCHEZ/AP/EMPICS
As many as 20% of workers in industrialised nations are shift workers and as many as 10% of these have insomnia or excessive sleepiness and are at increased risk from peptic ulcers, coronary heart disease, insulin resistance, depression, sleepiness related unintentional injury, and curtailed social and family activities. Many of these people work in health care and the transportation industries.
The study found that treatment with the drug resulted in a modest improvement from baseline in what is called night time sleep latency—the interval between the time a person attempts to fall asleep and the onset of sleep. The test was done as an objective measure of sleep tendency during the night, when these patients normally work. Mean sleep latency was longer at night in the group taking modafinil—by 1.7 (standard error of the mean 0.4) minutes v 0.3 (0.3) minutes (P=0.002)—so their sleep tendency during their night work hours was reduced. Patients receiving modafinil also had reduced frequency and duration of attention lapse during night time performance testing on the Psychomotor Vigilance Test (change from baseline, a reduction in lapse frequency of 2.6 compared with an increase of 3.8, P<0.001). Proportionally fewer patients reported having had or nearly having had unintentional injuries while commuting home (29% v 54%; P<0.001). Patients treated with modafinil continued to have excess sleepiness and impaired performance at night, however.
An editorial accompanying the article said that modafinil may yet be shown to be an effective and safe adjunct to comprehensive strategies for shift work sleep disorder (p 519).
Brian Murray, a neurologist specialising in sleep medicine at the University of Toronto and Sunnybrook and Women's College Hospital, commented that the dose used in the study (200 mg) is sometimes doubled in treating narcolepsy or other disorders "so it's possible they could find more of an effect with a larger dose or other strategies. we don't think at this point that the medications can replace the need for sleep."(David Spurgeon)