Abstract
This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to the Commissioner of the Food and Drug Administration (United States FDA). Almost every month, new information appears about the risks of hypnotics (sleeping pills). This review includes new information on the growing USA overdose epidemic, eight new epidemiologic studies of hypnotics' mortality not available for previous compilations, and new emphasis on risks of short-term hypnotic prescription. The most important risks of hypnotics include excess mortality, especially overdose deaths, quiet deaths at night, infections, cancer, depression and suicide, automobile crashes, falls, and other accidents, and hypnotic-withdrawal insomnia. The short-term use of one-two prescriptions is associated with greater risk per dose than long-term use. Hypnotics are usually prescribed without approved indication, most often with specific contraindications, but even when indicated, there is little or no benefit. The recommended doses objectively increase sleep little if at all, daytime performance is often made worse, not better, and the lack of general health benefits is commonly misrepresented in advertising. Treatments such as the cognitive behavioral treatment of insomnia and bright light treatment of circadian rhythm disorders might offer safer and more effective alternative approaches to insomnia.
Highlights
This is a reassessment of hypnotic drug risks and benefits, updating and expanding information presented October 26, 2015 to the Commissioner of the Food and Drug Administration (United States FDA) as part B of Petition FDA-2015-P-3959, accessible in April, 2016 at http://www.regulations.gov/#!docketDetail;D=FDA-2015P-3959 along with Comments responding to that Petition
Risks of hypnotic drugs Hypnotic drugs increase all-cause mortality Use of hypnotic drugs is associated prospectively with a greatly increased risk of all-cause mortality. Some of this mortality has been documented as deaths caused by hypnotics by Medical Examiners, attributed to respiratory arrests resulting from “overdose.” it is likely that many deaths from respiratory depression occur among patients never seen by coroners, especially when the death is caused by a combination of hypnotics with other contributing factors, so that the lethal hypnotic dosage may by itself have been within currently-customary dosage ranges
Summary of mortality risk epidemiology Altogether, the epidemiologic literature is conclusive that hypnotic use is associated with excess mortality
Summary
This is a reassessment of hypnotic drug risks and benefits, updating and expanding information presented October 26, 2015 to the Commissioner of the Food and Drug Administration (United States FDA) as part B of Petition FDA-2015-P-3959, accessible in April, 2016 at http://www.regulations.gov/#!docketDetail;D=FDA-2015P-3959 along with Comments responding to that Petition. Sensitivity studies showed that little of the hypnotic-associated mortality could be explained by known confounders or use of hypnotics before commencement of the study In this sample, prescriptions for each of the following drugs were found to significantly predict increased mortality with statistical significance: zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam or quazepam, and barbiturates prescribed to induce sleep. Another Taiwanese study observed that use of zolpidem was associated with increased risk of pyogenic liver abscess[36]. Epidemiologic evidence indicates that hypnotics cause the mild upper-respiratory infections most commonly reported in available controlled clinical trials[31], and more severe and life-threatening infections Since such infections demonstrably impair survival, infection is shown to be an additional mechanism by which hypnotics covertly increase mortality. Short and long sleep and sleeping pills: Is increased mortality associated? Arch Gen Psychiatry 1979;36(1):[]
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