Zolpidem and Driving Impairment — Identifying Persons at Risk

Farkas, Ronald H.; Unger, Ellis F.; Temple, Robert

doi:10.1056/nejmp1307972

Cited by 112 publications

(70 citation statements)

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“…Specifically, we are not aware of any published reports indicating that higher plasma concentrations of zolpidem in women are associated with a greater prevalence of residual sedative or performance-impairing effects, such as impaired driving ability the morning after taking a bedtime dose of zolpidem [28]. The US Food and Drug Administration has mandated that initial doses of zolpidem be reduced by 50 % for non-elderly women, in order to reduce the putative risk [29]. This is applicable for all dosage forms of zolpidem-whether oral zolpidem tablets taken at bedtime, or ZST taken for middle-of-thenight awakening.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects

et al. 2014

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Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects

et al. 2014

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“…At the clinical stage, gender effects may also be relevant. Many examples of sex-and genderbased findings have affected diagnostic, prevention, and treatment strategies for women and men (31)(32)(33).…”

Section: Translational and Clinical Researchmentioning

confidence: 99%

Studying both sexes: a guiding principle for biomedicine

2015

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In May 2014, the U.S. National Institutes of Health (NIH) announced that it will ensure that investigators account for sex as a biological variable (SABV) in NIHfunded preclinical research as part of the agency's rigor and transparency initiative. Herein, I describe in more detail the rationale behind the SABV policy component and provide additional detail about policy goals. In short, studying both sexes is a guiding principle in biomedical research that will expand knowledge toward turning discovery into health. NIH expects that considering SABV in preclinical research will help to build a knowledge base that better informs the design of clinical research and trials in humans. Integrating the practice of studying both sexes in preclinical research will, over time, expand our currently incomplete knowledge base that plays a critical role in informing the development of sexand gender-appropriate medical care for women and men.-Clayton, J. A. Studying both sexes: a guiding principle for biomedicine. FASEB J. 30, 519-524 (2016). www.fasebj.org

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“…17 Therefore, riskbenefit considerations in regards to hypnotic medications may be informed by the degree of misperception, especially in light of the growing literature regarding the adverse effects associated with hypnotic medications, including falls, motor vehicle accidents, and parasomnia. 18,19 Of note, there is no evidence that extending sleep duration or continuity via hypnotic therapy mitigates the risks thought to be associated with insomnia. Importantly, misperception may itself be a target for intervention, as several publications suggest that misperception is state-like.…”

Section: Sleep Fragmentation Does Not Explain Misperception Of Latencmentioning

confidence: 99%

Sleep Fragmentation Does Not Explain Misperception of Latency or Total Sleep Time

Saline

Goparaju

Bianchi

2016

Journal of Clinical Sleep Medicine

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Study Objectives: Perception of sleep-wake times may differ from objective measures, although the mechanisms remain elusive. Quantifying the misperception phenotype involves two operational challenges: defining objective sleep latency and treating sleep latency and total sleep time as independent factors. We evaluated a novel approach to address these challenges and test the hypothesis that sleep fragmentation underlies misperception. Methods: We performed a retrospective analysis on patients with or without obstructive sleep apnea during overnight diagnostic polysomnography in our laboratory (n = 391; n = 252). We compared subjective and objective sleep-wake durations to characterize misperception. We introduce a new metric, sleep during subjective latency (SDSL), which captures latency misperception without defining objective sleep latency and allows correction for latency misperception when assessing total sleep time (TST) misperception. Results:The stage content of SDSL is related to latency misperception, but in the opposite manner as our hypothesis: those with > 20 minutes of SDSL had less N1%, more N3%, and lower transition frequency. After adjusting for misperceived sleep during subjective sleep latency, TST misperception was greater in those with longer bouts of REM and N2 stages (OSA patients) as well as N3 (non-OSA patients), which also did not support our hypothesis. Conclusions: Despite the advantages of SDSL as a phenotyping tool to overcome operational issues with quantifying misperception, our results argue against the hypothesis that light or fragmented sleep underlies misperception. Further investigation of sleep physiology utilizing alternative methods than that captured by conventional stages may yield additional mechanistic insights into misperception. I NTRO DUCTI O NAssessment of sleep often includes subjective reports of sleepwake durations, in clinical practice as well as epidemiological studies of sleep duration.1 However, when concurrent objective sleep measurements are available, it is not uncommon to observe that the subjective responses may differ. Underestimation of total sleep time has been previously observed in healthy adults under experimental circumstances, as well as insomnia patients during polysomnography (PSG).2-4 This phenomenon, sometimes termed misperception, may manifest as either overestimating sleep latency (SL) or underestimating total sleep time (TST), or both.4 Some patients with obstructive sleep apnea (OSA) may also exhibit misperception, though perhaps not to the same extent as those with insomnia symptoms. 5-7Several hypotheses have arisen regarding the basis for misperception, although a unified explanation remains elusive. For example, misperception has been linked with anxiety and mood, 3,8 personality traits, and sleep physiology measures such as electroencephalogram patterns of alpha-delta sleep or cyclic alternating pattern and high frequency electroencephalography (EEG) content. [9][10][11][12][13] In addition, we previously investigated possible relat...

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Zolpidem and Driving Impairment — Identifying Persons at Risk

Cited by 112 publications

References 1 publication

Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects

Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects

Studying both sexes: a guiding principle for biomedicine

Sleep Fragmentation Does Not Explain Misperception of Latency or Total Sleep Time

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