Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation, sleep maintenance, and daytime sleepiness

Walsh, James K.; Salkeld, Lynette; Knowles, Lisa J.; Tasker, Tim; Hunneyball, Ian

doi:10.1016/j.sleep.2009.07.012

Cited by 26 publications

(10 citation statements)

References 14 publications

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“…The KSS was included as a validated measure of subjective sleepiness that has been found to be sensitive to sleepiness in other studies of treatments for insomnia. 19 Utility indices combining efficacy and safety variables have also been developed and used effectively in studying treatments in other disease areas. 20 Clinically significant differences from placebo were defined in advance as superiority by ≥ 6% (equivalent to > 30 minutes increase in time spent asleep, which is a clinically significant difference) on change from baseline of SE at days 1 and 2 and no change of > 4 units from baseline on the KSS at 1 hour after morning waketime on days 2 and 3.…”

Section: Etho Ds Objectivesmentioning

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

263

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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Section: Etho Ds Objectivesmentioning

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

263

105

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“…The specific criteria sets suggested in these trials are shown in Table 3. [20][21][22][23][24][25][26][27][28] As noted, most of these criteria sets considered both average values of selected sleep measures across 2 qualifying nights of PSG and the magnitude of these measures on each night separately. As such, these selection criteria not only reflect a specific level of sleep difficulty on average, but also a degree of persistence in that sort of disturbance.…”

Section: Tests Of Previously Reported Psg Qualifying Criteriamentioning

confidence: 99%

“…In fact, less than a third of the insomnia sufferers met most of these selection criteria. The Walsh et al PSG criteria, 25 based on TST and MSLT sleep latency measures, had relatively poor sensitivity and specificity. Hence, none of the criterion sets seem to convey sleep characteristics that are specific to insomnia.…”

Section: -Roc Plots For Home Psg Measuresmentioning

confidence: 99%

Sensitivity and Specificity of Polysomnographic Criteria for Defining Insomnia

Edinger

Ulmer

Means

2013

Journal of Clinical Sleep Medicine

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Study Objectives: In recent years, polysomnography-based eligibility criteria have been increasingly used to identify candidates for insomnia research, and this has been particularly true of studies evaluating pharmacologic therapy for primary insomnia. However, the sensitivity and specifi city of PSG for identifying individuals with insomnia is unknown, and there is no consensus on the criteria sets which should be used for participant selection. In the current study, an archival data set was used to test the sensitivity and specifi city of PSG measures for identifying individuals with primary insomnia in both home and lab settings. We then evaluated the sensitivity and specifi city of the eligibility criteria employed in a number of recent insomnia trials for identifying primary insomnia sufferers in our sample. Design: Archival data analysis. Settings: Study participants' homes and a clinical sleep laboratory.Participants: Adults: 76 with primary insomnia and 78 noncomplaining normal sleepers. Measurements and Results: ROC and cross-tabs analyses were used to evaluate the sensitivity and specifi city of PSG-derived total sleep time, latency to persistent sleep, wake after sleep onset, and sleep effi ciency for discriminating adults with primary insomnia from normal sleepers. None of the individual criteria accurately discriminated PI from normal sleepers, and none of the criteria sets used in recent trials demonstrated acceptable sensitivity and specifi city for identifying primary insomnia. Conclusions:The use of quantitative PSG-based selection criteria in insomnia research may exclude many who meet current diagnostic criteria for an insomnia disorder. keywords: Insomnia, PSG, research, sensitivity, specifi city Citation: Edinger JD; Ulmer CS; Means MK. Sensitivity and specifi city of polysomnographic criteria for defi ning insomnia.

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“…98 Studies on newly developing benzodiazepine-receptor drugs have yielded more positive results. 99,100 These results may pave the way to develop ideal hypnotics for older patients with insomnia in the near future.…”

Section: Hypnotics: Benzodiazepine-receptor Agonistsmentioning

confidence: 91%

Management of Late-Life Insomnia

Yang

Lee²,

Yeh

2011

Clinical Medicine Insights: Geriatrics

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Insomnia is a common complaint that can have significant daytime consequences. The prevalence of chronic insomnia may increase with age. The management of late-life insomnia can be complicated because aging is associated with normal changes in sleep structure, continuity, and timing, as well as a higher rate of medical and psychiatric disorders. A thorough evaluation and conceptualization of patients' problems should be conducted for effective treatment planning. Both non-pharmacological and pharmacological strategies have been proven effective in treating insomnia in elderly populations. Behavioral intervention and cognitive behavioral therapy for insomnia are recommended as first considerations. Light therapy may be administered for misalignment of the circadian phase. When necessary, hypnotic medications may be added with adequate safety precautions and consideration of comorbid conditions.

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Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation, sleep maintenance, and daytime sleepiness

Cited by 26 publications

References 14 publications

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

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

Sensitivity and Specificity of Polysomnographic Criteria for Defining Insomnia

Management of Late-Life Insomnia

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