Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring

Staner, Luc; Ertle, Stéphane; Boeijinga, Peter H.; Rinaudo, Gilbert; Arnal, Marie Agnès; Muzet, Alain; Luthringer, R.

doi:10.1007/s00213-005-0082-8

Cited by 73 publications

(76 citation statements)

References 43 publications

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“…[24][25][26][27] However, most studies of the effect of zolpidem on driving have examined the next day residual effect and have shown no impairment when conducted eight or nine hours after ingestion. 28,29 The reason that zolpidem is often implicated in sleep-related complex behaviors is not clear, but it is the most often prescribed sleeping pill in the United States. For example, the VONA database, which captures over one-half of the US prescriptions, found that 63% of the hypnotic sedatives prescribed by primary care providers in 2007 were zolpidem or zolpidem extended release, compared to only 29% for eszopiclone and temazepam combined.…”

Section: Legal Case 4 April 2009mentioning

confidence: 99%

Zolpidem Ingestion, Automatisms, and Sleep Driving: A Clinical and Legal Case Series

Poceta

2011

Journal of Clinical Sleep Medicine

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study Objectives: To describe zolpidem-associated complex behaviors, including both daytime automatisms and sleeprelated parasomnias. Methods: A case series of eight clinical patients and six legal defendants is presented. Patients presented to the author after an episode of confusion, amnesia, or somnambulism. Legal defendants were being prosecuted for driving under the infl uence, and the author reviewed the cases as expert witness for the defense. Potential predisposing factors including comorbidities, social situation, physician instruction, concomitant medications, and patterns of medication management were considered. Results: Patients and defendants exhibited abnormal behavior characterized by poor motor control and confusion. Although remaining apparently interactive with the environment, all reported amnesia for 3 to 5 hours. In some cases, the episodes began during daytime wakefulness because of accidental or purposeful ingestion of the zolpidem and are considered automatisms. Other cases began after ingestion of zolpidem at the time of going to bed and are considered parasomnias. Risk factors for both wake and sleep-related automatic complex behaviors include the concomitant ingestion of other sedating drugs, a higher dose of zolpidem, a history of parasomnia, ingestion at times other than bedtime or when sleep is unlikely, poor management of pill bottles, and living alone. In addition, similar size and shape of two medications contributed to accidental ingestion in at least one case. Conclusions s C i e n T i F i C i n V e s T i g a T i O n sT he ingestion of zolpidem and other hypnotic sedative medications for the treatment of insomnia has been associated with sleepwalking and other complex behaviors including sleep eating and sleep driving.1-5 When ingested during the daytime, hypnotic sedatives impair cognition, memory, and motor performance. 6 There are also reports of a high frequency of blood levels of hypnotic sedatives in drivers apprehended for driving under the infl uence (DUI).7-9 An advisory letter was sent and change in package insert information occurred on March 14, 2007, alerting physicians and the public to the possibility of complex behaviors with all hypnotic sedatives.According to the prescribing information for Ambien and Ambien CR, zolpidem is an imidazopyridine chemical class agent available in the US since 1992. It is chemically unrelated to benzodiazepine and barbiturate hypnotic sedatives. Zolpidem in vitro binds the BZ1 receptor of the GABA(A) complex with high affi nity ratio for the alpha1/alpha5 subunits. Mean peak concentrations were 59 (range 29 to 113) after ingestion of the 5 mg tablet and 121 (range 58 to 272) after ingestion of the 10 mg tablet (ng/mL). Time to maximum concentration was 1.6 h for both doses (but 2.2 h if taken with food) with a half-life of approximately 2.6 h (range 1.4 to 4.5) The zolpidem extended release formulation 12.5 mg tablets produced a maximum concentration of 134 (69 to 197) at 1.5 hours. Co-administration with fl uoxetine increased ha...

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Section: Legal Case 4 April 2009mentioning

confidence: 99%

Zolpidem Ingestion, Automatisms, and Sleep Driving: A Clinical and Legal Case Series

Poceta

2011

Journal of Clinical Sleep Medicine

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“…Six studies evaluating sleep quality reported moderately large improvement in this parameter based on SMD. 57,60,76,78,79,82 Improvement in PSG SE in the four studies included also exceeded the clinical significance threshold. 73,76,77,82 Number of awakenings (objective) fell below the clinical significance threshold.…”

Section: Discussionmentioning

confidence: 89%

“…57,59,60,70,[72][73][74][75][76][77][78][79] The overall quality of evidence was downgraded to very low due to significant heterogeneity, imprecision, and risk of publication bias. The evidence for zolpidem 10 mg was weakly in favor of its effectiveness for improving sleep onset, sleep maintenance, sleep quality, SE and TST.…”

Section: Discussionmentioning

confidence: 99%

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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Introduction:The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations:The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance in...

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“…It has great potential for residual sleepiness in the morning. 10 Zaleplon is a pyrazolopyrimidine, has the ultrashort half-life (1 hr), and binding similar to zolpidem (GABA A receptors) and its main indication is for rapid induction of sleep, with little effect on its maintenance and can be used in the middle of the night, in cases of early awakening. 9 Zolpidem and zaleplon slightly alter the structure of sleep, are well-tolerated and are associated with little occurrence of tolerance and dependence with prolonged use.…”

Section: Second Generation Hypnotics (Z-drug Hypnotics)mentioning

confidence: 99%

Pharmacotherapeutic options for treatment of insomnia

Singh

2014

Int J Basic Clin Pharmacol

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Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring

Cited by 73 publications

References 43 publications

Zolpidem Ingestion, Automatisms, and Sleep Driving: A Clinical and Legal Case Series

Zolpidem Ingestion, Automatisms, and Sleep Driving: A Clinical and Legal Case Series

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Pharmacotherapeutic options for treatment of insomnia

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