Perception of Lemborexant Effectiveness as Assessed by the Patient Global Impression-Insomnia Questionnaire.

IF 3.4 2区医学 Q2 CLINICAL NEUROLOGY

Nature and Science of Sleep Pub Date : 2025-04-08 eCollection Date: 2025-01-01 DOI:10.2147/NSS.S499090

Christopher L Drake, Jane Yardley, Kate Pinner, Margaret Moline, Manoj Malhotra

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Abstract

Objective: Using data from a clinical study of lemborexant, evaluate responses to the Patient Global Impression-Insomnia (PGI-I) questionnaire, a simple 4-item questionnaire that assesses patients' perceptions of the effects of medication on sleep, which may help evaluate clinically meaningful changes from the patient's perspective.

Methods: Study E2006-G001-303, a 12-month, placebo (PBO)-controlled (first 6 months) Phase 3 study in adults with insomnia disorder, randomized subjects (1:1:1) to lemborexant 5 mg (LEM5; n=316), 10 mg (LEM10; n=315), or PBO (n=318). The second 6 months are not presented here. PGI-I results were analyzed post hoc in relation to patient-reported (subjective) sleep-onset latency (sSOL) and total-sleep-time (sTST).

Results: At 6 months: 67.3% (LEM5) and 68.8% (LEM10) of subjects reported positive effects of medication helping them sleep versus 45.0% (both p<0.0001) with PBO. Positive effects on "time to fall asleep" were reported by 72.8% (LEM5) and 73.1% (LEM10) versus 46.1% with PBO (p<0.0001), and 58.0% (LEM5) and 62.0% (LEM10) reported positive effects on sleep duration versus 39.9% with PBO (p<0.0001). Subjects reporting positive effects on "time to fall asleep" had greater change from baseline (CFB; improvement) at 6 months in median sSOL (in minutes; LEM5= -26.8; LEM10= -32.1; PBO= -17.5; p<0.01) versus those reporting negative effects (LEM5= -9.1; LEM10= -10.4; PBO= -8.6; LEM5 vs PBO, p=0.52; LEM10 vs PBO, p=0.69). For sTST (in minutes) at 6 months, mean CFB tended to be greater for subjects reporting positive (LEM5=81.2, LEM10=93.2, PBO=74.8; LEM5 vs PBO, p=0.28; LEM10 vs PBO, p=0.18) versus negative (LEM5=46.4, LEM10=35.0, PBO=38.6; LEM5 vs PBO, p=0.44; LEM10 vs PBO, p=0.52) effects, although this was not statistically significant.

Conclusion: Patient impressions of the effects of lemborexant were positive based on the PGI-I and reflected improvements in subjective sleep outcome measures, indicating that the brief PGI-I tool may be useful in clinical practice.

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患者整体印象-失眠症问卷评估的嗅觉效果感知。

目的：利用lemborexant临床研究的数据，评估患者对患者整体印象-失眠（PGI-I）问卷的反应，这是一份简单的4项问卷，用于评估患者对药物对睡眠影响的看法，这可能有助于从患者的角度评估临床有意义的变化。方法：研究E2006-G001-303，一项为期12个月，安慰剂（PBO）对照（前6个月）的3期研究，随机受试者（1:1:1）服用lemborexant 5 mg (LEM5；n=316), 10 mg (LEM10；n=315)或PBO （n=318）。第二个6个月没有在这里展示。事后分析PGI-I结果与患者报告的（主观）睡眠发作潜伏期（sSOL）和总睡眠时间（sTST）的关系。结果：6个月时：67.3% （LEM5）和68.8% （LEM10）的受试者报告药物对他们睡眠的积极影响，45.0% (ppppp均=0.52；LEM10 vs PBO, p=0.69)。对于6个月时的sTST（以分钟为单位），报告阳性的受试者的平均CFB倾向于更高(LEM5=81.2, LEM10=93.2， PBO=74.8；LEM5 vs PBO, p=0.28；LEM10 vs PBO, p=0.18)与阴性(LEM5=46.4, LEM10=35.0， PBO=38.6；LEM5 vs PBO, p=0.44；LEM10 vs PBO, p=0.52)效应，尽管这没有统计学意义。结论：基于PGI-I，患者对lemborexant效果的印象是积极的，反映了主观睡眠结果测量的改善，表明简短的PGI-I工具可能在临床实践中有用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature and Science of Sleep Neuroscience-Behavioral Neuroscience

CiteScore

5.70

自引率

5.90%

发文量

245

审稿时长

16 weeks

期刊介绍： Nature and Science of Sleep is an international, peer-reviewed, open access journal covering all aspects of sleep science and sleep medicine, including the neurophysiology and functions of sleep, the genetics of sleep, sleep and society, biological rhythms, dreaming, sleep disorders and therapy, and strategies to optimize healthy sleep. Specific topics covered in the journal include: The functions of sleep in humans and other animals Physiological and neurophysiological changes with sleep The genetics of sleep and sleep differences The neurotransmitters, receptors and pathways involved in controlling both sleep and wakefulness Behavioral and pharmacological interventions aimed at improving sleep, and improving wakefulness Sleep changes with development and with age Sleep and reproduction (e.g., changes across the menstrual cycle, with pregnancy and menopause) The science and nature of dreams Sleep disorders Impact of sleep and sleep disorders on health, daytime function and quality of life Sleep problems secondary to clinical disorders Interaction of society with sleep (e.g., consequences of shift work, occupational health, public health) The microbiome and sleep Chronotherapy Impact of circadian rhythms on sleep, physiology, cognition and health Mechanisms controlling circadian rhythms, centrally and peripherally Impact of circadian rhythm disruptions (including night shift work, jet lag and social jet lag) on sleep, physiology, cognition and health Behavioral and pharmacological interventions aimed at reducing adverse effects of circadian-related sleep disruption Assessment of technologies and biomarkers for measuring sleep and/or circadian rhythms Epigenetic markers of sleep or circadian disruption.