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27. Impact of middle-of-the-night awakenings on health status, activity impairment, and costs

Author

Moline M, DiBonaventura MD, Shah D, and Ben-Joseph R

Subjects
Psychiatry, RC435-571, Neurophysiology and neuropsychology, QP351-495
Abstract

Margaret Moline,1 Marco daCosta DiBonaventura,2 Dhvani Shah,1 Rami Ben-Joseph1 1Purdue Pharma, LP, Stamford, CT, USA; 2Health Outcomes Practice, Kantar Health, New York, NY, USA Study objectives: Middle-of-the-night (MOTN) awakenings with difficulty returning to sleep are among the most common symptoms of insomnia. Despite the epidemiological studies that have been conducted, there is a lack of data on the impact of MOTN awakenings on health status and socioeconomic indicators in comparison with other insomnia symptoms. Methods: Data were analyzed from the 2011 US National Health and Wellness Survey (adults ≥18 years old; N=60,783), which asked respondents whether they had experienced specific symptoms of insomnia (ie, MOTN awakenings, difficulty falling asleep, waking several times, waking up too early, or poor quality of sleep). Respondents who reported only one insomnia symptom were compared among insomnia subgroups and with no insomnia symptom controls with respect to demographics, health history, and health outcomes (Short Form-12v2, Work Productivity and Activity Impairment questionnaire, and costs). Additional analyses compared respondents with only MOTN awakenings and matched controls on health outcomes. Results: MOTN awakenings without other insomnia symptoms were reported by 3.5% of respondents. Poor quality of sleep was associated with the strongest effects on health status compared with other insomnia symptoms even after adjusting for demographic and health characteristics differences. Differences across insomnia symptoms with respect to cost-related outcomes were generally modest, though all were higher (if not significantly so) than respondents without insomnia. Respondents who experienced only waking several times and only MOTN awakenings had the highest direct costs, while respondents who experienced only poor quality of sleep and only difficulty falling asleep had the highest indirect costs. Respondents with only MOTN awakenings reported significantly worse mental and physical health status and worse health utilities relative to insomnia-free matched controls (all P

Published
2014

32. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder:results from a phase 3 randomized clinical trial

Author

Yardley, J. (Jane), Kärppä, M. (Mikko), Inoue, Y. (Yuichi), Pinner, K. (Kate), Perdomo, C. (Carlos), Ishikawa, K. (Kohei), Filippov, G. (Gleb), Kubota, N. (Naoki), and Moline, M. (Margaret)

Subjects
Insomnia, Sleep maintenance, Sleep onset, Lemborexant, Orexin, Pharmacotherapy
Abstract

Objective/background: Lemborexant is a dual orexin receptor antagonist approved in the United States, Japan, and Canada for the treatment of insomnia in adults. We report effectiveness and safety outcomes in subjects with insomnia who received up to twelve months of continuous lemborexant treatment in Study E2006-G000-303 (Study 303; SUNRISE-2). Patients/methods: Study 303 was a twelve-month, global, multicenter, randomized, double-blind, parallel-group, Phase 3 study divided into two treatment periods. In Treatment Period 1 (first six months), subjects (n = 949, Full Analysis Set) were randomized to daily placebo, lemborexant 5 mg (LEM5) or lemborexant 10 mg (LEM10). In Treatment Period 2 (second six months), placebo subjects were rerandomized to LEM5 or LEM10, and subjects randomized to lemborexant continued their assigned treatment (LEM5, n = 251; LEM10, n = 226). Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored. Results: For all sleep parameters, the significant benefits observed with LEM5 and LEM10 versus placebo over six months were maintained at twelve months in subjects who received twelve continuous months of treatment. There was no evidence of rebound insomnia or withdrawal in either lemborexant group following treatment discontinuation. Over twelve months of lemborexant treatment, most TEAEs were mild/moderate; the most common TEAEs were nasopharyngitis, somnolence and headache. Conclusions: LEM5 and LEM10 had significant benefit on sleep onset and sleep maintenance compared with placebo, and importantly, lemborexant effectiveness persisted at twelve months, suggesting that lemborexant may provide long-term benefits for subjects with insomnia. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.

Published
2021

34. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder:results from the phase 3 randomized clinical trial SUNRISE 2

Author

Kärppä, M. (Mikko), Yardley, J. (Jane), Pinner, K. (Kate), Filippov, G. (Gleb), Zammit, G. (Gary), Moline, M. (Margaret), Perdomo, C. (Carlos), Inoue, Y. (Yuichi), Ishikawa, K. (Kohei), and Kubota, N. (Naoki)

Subjects
pharmacotherapy, orexin, insomnia, clinical trial, lemborexant
Abstract

Study Objectives: To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder. Methods: This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. Results: Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths. Conclusions: LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39

Published
2020

37. Contributor contact details

Author

Watson, J., primary, Zielinski, O., additional, Watson, J., additional, Wernand, M.R., additional, Burg, Den, additional, Cunningham, A., additional, McKee, D., additional, Coble, P.G., additional, Prien, R.D., additional, Moline, M.A., additional, Oliver, M.J., additional, Orrico, C., additional, Zaneveld, R., additional, Shulman, I., additional, Busch, J.A., additional, Cembella, A.D., additional, Bowers, D.G., additional, Schulz, J., additional, Kocak, D.M., additional, Ouyang, B., additional, Burns, N.M., additional, Caimi, F.M., additional, Dalgleish, Fraser R, additional, Sveen, J.K., additional, De Dominicis, L., additional, Kirkwood, W.J., additional, Brewer, P.G., additional, Glisic, B., additional, Zimmerman, R.C., additional, Hill, V.J., additional, Sukenik, Charles I., additional, Mànuel-Làzaro, A., additional, Molino-Minero-Re, E., additional, del Río-Fernández, J., additional, Nogueras-Cervera, M., additional, Johnsen, G., additional, Pettersen, R., additional, Dierssen, H., additional, Van Ardelan, M., additional, Søreide, F., additional, Ludvigsen, M., additional, Volent, Z., additional, Fearns, P., additional, Moline, M., additional, Jaffe, J.S., additional, Franks, P.J.S., additional, Briseño-Avena, C., additional, Roberts, P.L.D., additional, and Laxton, B., additional

Published
2013
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