Update on the Safety Considerations in the Management of Insomnia With Hypnotics

Lieberman, Joseph A.

doi:10.4088/pcc.v09n0105

Cited by 68 publications

(70 citation statements)

References 52 publications

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“…In other jurisdictions, melatonin is available in pharmaceutical grade. In laboratory environments, pharmaceutical-grade melatonin has been effective in circadian entrainment or facilitation of daytime sleep (8,9,118,119,196,231).…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

“…In addition, eszopiclone ( Lunesta w ) has a half-life of 5 to 6 h with minimal residual drug effects after as little as 10 h post dose ( 114 ). Ramelteon (Rozerem w ) is a novel hypnotic in that it targets the melatonin receptors in the brain in order to regulate the body's sleep-wake cycle ( 119 ). Research indicates that this drug is effi cacious for sleep onset, but not for sleep maintenance ( 119 ).…”

Section: A Hypnoticsmentioning

confidence: 99%

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Fatigue Countermeasures in Aviation

Caldwell¹,

Mallis²,

Caldwell³

et al. 2009

aviat space environ med

232

188

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Pilot fatigue is a significant problem in modern aviation operations, largely because of the unpredictable work hours, long duty periods, circadian disruptions, and insufficient sleep that are commonplace in both civilian and military flight operations. The full impact of fatigue is often underappreciated, but many of its deleterious effects have long been known. Compared to people who are well-rested, people who are sleep deprived think and move more slowly, make more mistakes, and have memory difficulties. These negative effects may and do lead to aviation errors and accidents. In the 1930s, flight time limitations, suggested layover durations, and aircrew sleep recommendations were developed in an attempt to mitigate aircrew fatigue. Unfortunately, there have been few changes to aircrew scheduling provisions and flight time limitations since the time they were first introduced, despite evidence that updates are needed. Although the scientific understanding of fatigue, sleep, shift work, and circadian physiology has advanced significantly over the past several decades, current regulations and industry practices have in large part failed to adequately incorporate the new knowledge. Thus, the problem of pilot fatigue has steadily increased along with fatigue-related concerns over air safety. Accident statistics, reports from pilots themselves, and operational flight studies all show that fatigue is a growing concern within aviation operations. This position paper reviews the relevant scientific literature, summarizes applicable U.S. civilian and military flight regulations, evaluates various in-flight and pre-/postflight fatigue countermeasures, and describes emerging technologies for detecting and countering fatigue. Following the discussion of each major issue, position statements address ways to deal with fatigue in specific contexts with the goal of using current scientific knowledge to update policy and provide tools and techniques for improving air safety.

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Section: Conclusion and Recommendationsmentioning

confidence: 99%

Section: A Hypnoticsmentioning

confidence: 99%

Fatigue Countermeasures in Aviation

Caldwell¹,

Mallis²,

Caldwell³

et al. 2009

aviat space environ med

232

188

View full text Add to dashboard Cite

show abstract

“…Chronic insomnia is a common complaint in primary care worldwide77 and insomnia has become increasingly recognized as a chronic disorder that requires treatment over the long-term 78. We think the case for long-term sedative-hypnotic use is strong, if these drugs are used appropriately.…”

Section: Resultsmentioning

confidence: 99%

“…In 2005 the FDA approved three drugs and no restrictions were placed on their therapeutic timeline. The three drugs approved are eszopiclone, ramelteon, and zolpidem extended release 78. However, failure of physicians to effectively manage long-term insomnia in patients tend to promote use of over-the-counter medications, not only increasing the chance of drug interactions but also resulting in a greater medical risk and potentially producing more side effects than the prescribed sedative-hypnotics.…”

Section: Resultsmentioning

confidence: 99%

An approach to long-term sedative-hypnotic use

Shahid¹,

Chung²,

Phillipson³

et al. 2012

NSS

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Insomnia is a common, often chronic medical disorder with significant medical and socioeconomic repercussions. However, unlike other medical conditions, there is intense debate as to whether the long-term treatment of insomnia is clinically appropriate. The perceived deleterious side effect of sedative-hypnotic medications may result in patients remaining untreated or undertreated. This review proposes that a more subtle approach needs to be taken in the management of patients with chronic insomnia and that long-term use of the newer sedative-hypnotics may be a feasible and effective treatment option when used in conjunction with thorough medical assessment and regular patient follow-up. This review discusses these issues and discusses the pros and cons of long-term sedative-hypnotic use.

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“…Benzodiazepines (BZD) and benzodiazepine receptor agonists (zolpidem, zaleplon, zopiclone, altogether Z-drugs) are most commonly prescribed for the treatment of insomnia [10, 11]. A meta-analysis of the risks and benefits of these therapeutic options in elderly patients reported statistically significant improvements in sleep, but also reported a statistically significant risk of adverse events [12, 13], including life-threatening ones [14].…”

Section: Introductionmentioning

confidence: 99%

Contribution of prolonged-release melatonin and anti-benzodiazepine campaigns to the reduction of benzodiazepine and z-drugs consumption in nine European countries

Clay

Falissard

Moore

et al. 2012

Eur J Clin Pharmacol

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BackgroundBenzodiazepines (BZD) and benzodiazepine receptor agonists (zolpidem, zaleplon, zopiclone, altogether Z-drugs) are most commonly prescribed for the treatment of insomnia. However, long-term use of BZD/Z-drugs is associated with major adverse events including, but not limited to, falls and fractures, domestic and traffic accidents, confusion, cognitive impairment, Alzheimer's disease and cancer. The prolonged use of these drugs is thought to be related to severe withdrawal symptoms and potential dependency. The chronic and extensive use of BZD/Z drugs has become a public health issue and has led to multiple campaigns to reduce both prescription and consumption of BZD/Z-drugs. Prolonged-release (PR) melatonin is the first of a new class of melatonin receptor agonist drugs that has demonstrated clinically relevant efficacy on improving quality of sleep and morning alertness, with a good safety profile.ObjectiveThis study aimed to analyze and evaluate the impact of anti-BZD/Z-drugs campaigns and the availability of alternative pharmacotherapy (PR-melatonin) on the consumption of BZD and Z-drugs in several European countries. MethodsAnnual sales data from nine European countries were extracted from the IMS sales database and analyzed to determine whether trends in use of these treatment options were attributed to campaigns and/or availability and affordability of safer alternatives on the market.ResultsCampaigns aiming to reduce the use of BZD/Z-drugs failed when they were not associated with the availability and market uptake of PR-melatonin. The reimbursement of PR-melatonin supports better penetration rates and a higher reduction in sales for BZD/Z-drugs.

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Update on the Safety Considerations in the Management of Insomnia With Hypnotics

Abstract: Overall, published studies report that the safety of insomnia treatments has improved considerably over the past 10 years with the introduction of agents that provide improved safety, particularly with regard to next-day residual effects and abuse liability.

Cited by 68 publications

References 52 publications

Fatigue Countermeasures in Aviation

Fatigue Countermeasures in Aviation

An approach to long-term sedative-hypnotic use

Contribution of prolonged-release melatonin and anti-benzodiazepine campaigns to the reduction of benzodiazepine and z-drugs consumption in nine European countries

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