Sleep Maintenance Insomnia: Strengths and Weaknesses of Current Pharmacologic Therapies

Rosenberg, Russell

doi:10.1080/10401230500464711

Cited by 114 publications

(87 citation statements)

References 91 publications

(97 reference statements)

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“…The benzodiazepines have a prominent hangover effect manifested by cognitive suppression and psychomotor agitation, and chemical dependency may occur [143][144][145]. The antidepressants are better tolerated but may carry anticholinergic and cardiac risks [146][147][148][149][150][151]. The nonbenzodiazepine sedatives carry the lowest side effect profile while maintaining similar efficacy on sleep parameters [128,[152][153][154][155][156][157][158][159][160].…”

Section: Insomniamentioning

confidence: 99%

Minimizing the effect of TBI-related physical sequelae on vocational return

McNamee

Walker²,

Cifu³

et al. 2009

JRRD

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Abstract-This article evaluated the common physical sequelae that affect return to work (RTW) after traumatic brain injury (TBI). We performed a Medline search and evaluation of current TBI rehabilitation texts. The information presented is a combination of published literature and clinical guidelines. The limitations faced by many patients with TBI can best be overcome through clever job search, job redesign, and community linkages with business and industry that are willing to partner in helping the patient with TBI regain employment. The physician plays a key role in communicating suggestions to the vocational specialist. The comorbidities described represent challenges to successful RTW. These problems are recurrent, long-term, and clearly affect job procurement, nature of job, level of required support, and likelihood of job retention. Conversely, these challenges should not be viewed as impenetrable obstacles. With appropriate supports such as compensatory strategies, job coaching, assistive technology, medical management, and job restructuring, successful RTW is viable option. Physicians must focus on employment outcomes in real jobs and not settle for volunteer work, sheltered work, or assessment and planning. Individuals should be placed in real work for real pay. Through close collaboration between the survivor of TBI, the physician, the vocational specialist, and community resources, successful employment for survivors of TBI is possible and must be prescribed a high value.

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Section: Insomniamentioning

confidence: 99%

Minimizing the effect of TBI-related physical sequelae on vocational return

McNamee

Walker²,

Cifu³

et al. 2009

JRRD

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“…5 Benzodiazepines, nonbenzodiazepine hypnotics ("z-drugs" such as zolpidem, zolpidem CR, and eszopiclone), and sedating antidepressants are the primary prescription medications currently used to treat insomnia in the United States, but there is need for agents that more effectively reduce wakefulness throughout the night without safety issues such as complex sleep-related behaviors and cognitive/psychomotor impairments. [6][7][8][9][10][11] Impairment of driving abilities the day following ; they help promote wakefulness by binding to the G-protein-coupled receptors, OX1R and OX2R. 9,16 The dual orexin receptor antagonist (DORA) suvorexant (approved in the United States and Japan 17 ) has been shown to treat insomnia disorder and is thought to block the wakefulness that is interfering with sleep.…”

Section: Introductionmentioning

confidence: 99%

Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study

Murphy

Moline

Mayleben³

et al. 2017

Journal of Clinical Sleep Medicine

264

105

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Study Objectives: To identify dose(s) of lemborexant that maximize insomnia treatment efficacy while minimizing next-morning residual sleepiness and evaluate lemborexant effects on polysomnography (PSG) measures (sleep efficiency [SE], latency to persistent sleep [LPS], and wake after sleep onset [WASO]) at the beginning and end of treatment. Methods: Adults and elderly subjects with insomnia disorder per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition were enrolled in a multicenter, randomized, double-blind, placebo-controlled, Bayesian, adaptive, parallel-group study, receiving lemborexant (1, 2.5, 5, 10, 15, 25 mg) or placebo for 15 nights. Efficacy assessments included a utility function that combined efficacy (SE) and safety (residual morning sleepiness as measured by Karolinska Sleepiness Scale [KSS]), PSG measures, and sleep diary. Safety assessments included KSS, Digit Symbol Substitution Test, computerized reaction time tests, and adverse events (AEs). Results: A total of 616 subjects were screened; 291 were randomized. Baseline characteristics were similar between lemborexant groups and placebo (~63% female, median age: 49.0 years). The study was stopped for early success after the fifth interim analysis when the 15-mg dose met utility index/KSS criteria for success; 3 other doses also met the criteria. Compared with placebo, subjects showed significant improvements in SE, subjective SE, LPS, and subjective sleep onset latency at the beginning and end of treatment for lemborexant doses ≥ 5 mg (P < .05). WASO and subjective WASO showed numerically greater improvements for doses > 1 mg. AEs, mostly mild to moderate, included dose-related somnolence. Conclusions: Lemborexant doses ranging from 2.5-10 mg provided efficacy for the treatment of insomnia while minimizing next-morning residual sleepiness.

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“…10 Hypnotics approved for bedtime use to prevent nocturnal awakenings have demonstrated inconsistent effects on sleep maintenance parameters during controlled treatment trials. 8 In light of these inconsistent efficacy profiles, experimental studies have begun exploring efficacy-safety of MOTN dosing of FDA-approved (for bedtime use) hypnotics 9,11-13 and investigational agents. 14,15 Although these studies have found MOTN dosing of these medications associated with improvements in sleep maintenance, trials involving off-label use of approved hypnotics have also found next-day compromises in psychomotor and cognitive functioning, 13,[16][17][18] especially at higher dosages.…”

Section: Brief Summarymentioning

confidence: 99%

Middle-of-the-Night Hypnotic Use in a Large National Health Plan

Roth

Berglund²,

Shahly³

et al. 2013

Journal of Clinical Sleep Medicine

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that are approved for nocturnal awakenings and/or prolonged wake time after nocturnal awakenings, all but one stipulate bedtime administration with middle-of-the-night use being explicitly disapproved to minimize risk of residual sedation. In other words, such bedtime hypnotics are designed to be preventative treatments for possible nocturnal awakenings rather than active treatments administered after nocturnal awakenings occur. The single hypnotic accepted by the FDA for as-needed MOTN Study Objectives: Although diffi culty maintaining sleep (DMS) is the most common nighttime insomnia symptom among US adults, many FDA-approved hypnotics have indications only for sleep onset, stipulating bedtime administration to offset residual sedation. Given the well-known self-medication tendencies of insomniacs, concern arises that maintenance insomniacs might be prone to self-administer their prescribed hypnotics middle-of-the-night (MOTN) after nocturnal awakenings, despite little effi cacy-safety data supporting such use. However, no US data characterize the actual population prevalence or correlates of MOTN hypnotic use. Methods: Telephone interviews assessed patterns of prescription hypnotic use in a national sample of 1,927 commercial health plan members (ages 18-64) receiving prescription hypnotics within 12 months of study. The Brief Insomnia Questionnaire assessed insomnia symptoms. Results: 20.2% of respondents reported MOTN hypnotic use, including 9.0% who sometimes used twice-per-night (once at bedtime plus once MOTN) and another 11.2% who sometimes used MOTN, but never twice-per-night. The remaining 79.8% used exclusively at bedtime. Among exclusive MOTN users, only 14.0% used MOTN on the advice of their physician (52.6% of those seen by sleep medicine specialists and 42.6% by psychiatrists vs. 5.2% to 13.6% seen by other physicians). MOTN use predictors included DMS being the most bothersome sleep problem, long duration of hypnotic use, and low frequency of DMS. Conclusions: One-fi fth of patients with prescription hypnotics used MOTN, only a minority on advice from their physicians. Since signifi cant next-day cognitive and psychomotor impairment is documented with off-label MOTN hypnotic use, prescribing physicians should question patients about unsupervised MOTN dosing. Keywords: Insomnia, sleep maintenance, hypnotics, middleof-the-night, dosing, medication adherence, prevalence Citation: Roth T; Berglund P; Shahly V; Shillington AC; Stephenson JJ; Kessler RC. Middle-of-the-night hypnotic use in a large national health plan. J Clin Sleep Med 2013;9(7):661-668.http://dx.doi.org/10.5664/jcsm.2832 S C I E N T I F I C I N V E S T I G A T I O N SI nsomnia is the most common nighttime sleep problem, and sleep maintenance insomnia the most common insomnia symptom both in the general population 1 and among adults with clinical insomnia. 2 An estimated one-fourth of all noninstitutionalized US civilians and two-thirds of US insomniacs report frequent sleep maintenance problems involving nocturnal awakenings and/or p...

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Sleep Maintenance Insomnia: Strengths and Weaknesses of Current Pharmacologic Therapies

Abstract: New agents that offer relief of sleep maintenance insomnia without residual next day impairment while improving next day function are needed. Several compounds currently under development may offer clinicians a more effective and safer treatment for this common disorder.

Cited by 114 publications

References 91 publications

Minimizing the effect of TBI-related physical sequelae on vocational return

Minimizing the effect of TBI-related physical sequelae on vocational return

Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study

Middle-of-the-Night Hypnotic Use in a Large National Health Plan

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