774 Insomnia precedes suicidal ideation in a national longitudinal study of sleep continuity (NITES)

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A301-A301
Author(s):  
Andrew Tubbs ◽  
Knashawn Morales ◽  
Michael Grandner ◽  
Jason Ellis ◽  
Ivan Vargas ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Suicide Risk ◽  
Severity Index ◽  
Sleep Time ◽  
Wake Time ◽  
Sleep Diaries ◽  
Sleep Continuity ◽  
Race Ethnicity ◽  
Suicidal Thoughts And Behaviors ◽  
Insomnia Severity

Abstract Introduction Suicide is the 10th leading cause of death among US adults, and disrupted sleep significantly increases suicide risk. It is unclear, however, how quickly changes in sleep can affect suicidal thoughts and behaviors. Therefore, the present study explored whether insomnia, sleep continuity, and nightmares predicted subsequent suicidal thinking. Methods Data were drawn from N=1,248 individuals 35 years and older who were part of a 1-year prospective study of the natural history of insomnia. Suicidal ideation was measured biweekly from the Patient Health Questionnaire – 9 and dichotomized (Score = 0, No; Score > 0, Yes). The primary predictors were Insomnia Severity Index (ISI) score and total wake time, total sleep time, difficulty initiating/maintaining sleep, and nightmares (from daily sleep diaries). Predictors were averaged over the previous 2 weeks and measured 2 nights prior to measuring suicidal ideation. Data were modeled using generalized estimating equations to account for within-subject correlations and adjusted for age, sex, and race/ethnicity. Results A total of N=124 individuals (65% female) reported suicidal ideation during the study. In unadjusted models, no sleep variable was associated with subsequent suicidal ideation. However, after adjusting for age, sex, and race/ethnicity, insomnia severity was associated with subsequent suicidal ideation when averaged over the preceding 2 weeks (OR 1.09 per point on the ISI, 95% CI [1.03–1.16]) and measured 2 days prior (OR 1.11 per point on the ISI, 95% CI [1.01–1.22]). Stratified analyses showed that this effect was driven by age, with insomnia predicting suicidal ideation in individuals 55–64 and 65 and older. Conclusion Insomnia is a significant, proximal risk factor for suicidal ideation, particularly in older adults. Consequently, treatment of insomnia may represent an effective suicide risk reduction strategy. Support (if any) K24AG055602 R01AG041783

scholarly journals P129 A substantial percentage of patients with Chronic Insomnia do not appreciably increase Total Sleep Time after Cognitive Behavioural Therapy for Insomnia

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A63-A63
Author(s):  
H Scott ◽  
J Cheung ◽  
A Muench ◽  
H Ivers ◽  
M Grandner ◽  
...  
Keyword(s):  
Total Sleep Time ◽  
Sleep Onset ◽  
Severity Index ◽  
Randomised Clinical Trial ◽  
Sleep Time ◽  
Early Morning ◽  
Behavioural Therapy ◽  
Sleep Diary ◽  
Wake Time ◽  
Sleep Continuity

Abstract Introduction Total sleep time (TST) does not exceed baseline for the majority of patients after CBT-I. However by follow-up, TST increases by almost 1 hour on average. The current study investigated the extent to which this TST improvement is common and assessed for baseline predictors of increased TST after CBT-I. Methods This study is an archival analysis of data from a randomised clinical trial comparing acute CBT-I to acute CBT-I plus maintenance therapy (N = 80). The percent of patients that exceeded baseline TST by ≥30 minutes was assessed at post treatment and 3, 6, 12, and 24 months following treatment. Linear mixed models were conducted to assess the effect of patient demographics (age, sex, ethnicity, marital status), and baseline Sleep Diary-reported sleep continuity and Insomnia Severity Index (ISI) scores on changes in TST. Results 17% of patients achieved an appreciable increase in TST by treatment end, and this proportion only increased to 58% over time. Sleep Diary-reported sleep latency, wake after sleep onset, early morning awakenings, total wake time, TST, and sleep efficiency at baseline were associated with greater increases in TST after CBT-I (interaction ps < .03). Demographics and ISI scores were not significant predictors (interaction ps > .07). Conclusion A substantial proportion of patients do not appreciably increase TST after CBT-I, but patients with more severe sleep continuity disturbances at baseline exhibited the largest improvements. Whether all patients could increase their TST even further after CBT-I is a topic for further investigation.

scholarly journals 1108 Associations Between Insomnia And Anxiety Symptoms: Which Elements Of Insomnia Are Associated With Which Elements Of Anxiety?

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A421-A422
Author(s):  
A Kapoor ◽  
M L Perlis ◽  
C Bastien ◽  
N Williams ◽  
L Hale ◽  
...  
Keyword(s):  
Severity Index ◽  
Anxiety Symptoms ◽  
Anxiety Level ◽  
Future Research ◽  
Loss Of Control ◽  
Regression Analyses ◽  
Race Ethnicity ◽  
Healthy Activity ◽  
Insomnia Severity ◽  
Anxiety Questionnaire

Abstract Introduction It is still not clear which aspects of insomnia are associated with various aspects of anxiety problems. Knowing this could better guide treatment of insomnia comorbid with anxiety. Methods Data from the Sleep and Healthy Activity, Diet, Environment, and Socialization (SHADES) study were used, including N=1003 adults age 22-60. All participants completed the Insomnia Severity Index (ISI) and the GAD7 anxiety questionnaire. The ISI was divided into 3 sections, based on prior work: SLEEP symptoms (difficulty sleeping), DAYTIME symptoms (difficulty functioning), and PERCEPTION symptoms (dissatisfaction). GAD7 items included anxiety level, loss of control, worry about many things, difficulty relaxing, restlessness, irritability, and fear. Logistic regression analyses examined each symptom, with each component of the ISI as predictor, as well as age, sex, race/ethnicity and education as covariates. Results SLEEP symptoms were independently associated with control (OR=1.09, p=0.03), many worries (OR=1.1, p=0.017), restlessness (OR=1.1, p=0.009), and irritability (OR=1.1, p=0.04). DAYTIME symptoms were independently associated with anxiety level (OR=1.3, p<0.0005), control (OR=1.2, p<0.0005), many worries (OR=1.3, p<0.0005), difficulty relaxing (OR=1.2, p=0.004), restlessness (OR=1.3, p=0.001), and irritability (OR=1.2, p<0.0005). PERCEPTION symptoms were uniquely, independently associated with anxiety level (OR=1.1, p=0.03), control (OR=1.2, p=0.001), many worries (OR=1.2, p=0.001), difficulty relaxing (OR=1.4, p<0.0005), irritability (OR=1.2, p=0.018), and feelings of fear (OR=1.2, p=0.002). Conclusion The DAYTIME and PERCEPTION symptoms of insomnia were strongly related to anxiety symptoms. Current treatments for insomnia focus mainly on improving sleep. Future research should test the hypothesis that treating daytime symptoms of insomnia may aid patients with comorbid anxiety. Support The SHADES study was funded by R21ES022931. Dr. Grandner is supported by R01MD011600.

scholarly journals Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization

SLEEP ◽  
2020 ◽  
Vol 43 (11) ◽  
Author(s):  
Leonie Franziska Maurer ◽  
Colin Alexander Espie ◽  
Ximena Omlin ◽  
Matthew James Reid ◽  
Rachel Sharman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Severity Index ◽  
Sleep Restriction ◽  
Randomized Controlled ◽  
Time In Bed ◽  
Sleep Continuity ◽  
Insomnia Symptoms ◽  
Insomnia Severity

Abstract Study Objectives Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. Methods Participants aged 25–55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. Results Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63–1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was −4.49 (d = −1.40) and −4.35 at 12 weeks (d = −1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40–0.92) and sleep-related quality of life (d = 1.29). Conclusions For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.

scholarly journals 0152 Insomnia Severity and Daytime Complaints: What is to be Learned When These Domains are Discordant?

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A60-A60
Author(s):  
M L Perlis ◽  
J T Boyle ◽  
I Vargas ◽  
J Giller ◽  
M Seewald ◽  
...  
Keyword(s):  
Illness Severity ◽  
Two Dimensions ◽  
Composite Score ◽  
Community Based ◽  
Wake Time ◽  
Sleep Continuity ◽  
The Face ◽  
The Relationship ◽  
Insomnia Severity

Abstract Introduction If illness severity and daytime dysfunction are construed as categorical entities, it is possible to conceptualize the relationship between these variables in terms of a 2x2 matrix where the resultant cells represent a concordant dimension (quadrants 2 & 4 [high-high and low-low]) and a discordant dimension (quadrants 1 & 3 [high-low and low-high]). The question for the present analysis was, what percentage of subjects populate each quadrant and is it the case that the discordant dimension contains only a small percentage of subjects? Methods Illness severity and daytime dysfunction data was collected from individuals with sleep continuity complaints in archival/community-based sample (N = 4680; 60% female; Ages 18–89) (www.sleeplessinphilly.com). Illness severity was operationalized as Total Wake Time (TWT; [SL+WASO+EMA=TWT]) and daytime dysfunction was operationalized as the composite score of six daytime symptoms items. Median splits were calculated for each variable and subjects were typed accordingly (HH, LL, HL, & LH). Results Surprisingly, the sample was relatively equally distributed into the two dimensions; 38% and 23% for the concordant dimension and 13% and 26% for discordant dimension. Conclusion The 39% of subjects in the discordant groups might be thought of as complaining good sleepers (LH) and noncomplaining poor sleepers (HL). Other investigators have identified the LH subjects as individuals with “insomnia identity”. Alternatively, it is possible to characterize the whole dimension as being related to a mismatch between the individual’s sleep need and sleep ability. Those who need a lot, may suffer a lot, in the face of only a little (LH) whereas those who need a little, may suffer only a little, in the face of a lot (HL). Support  

scholarly journals 1071 Subjective Measures Of Hyperarousal Predict Subjective Longitudinal And Retrospective Measures Of Sleep Quality In Individuals Exposed To Trauma

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A408-A408
Author(s):  
A Kram Mendelsohn ◽  
C Daffre ◽  
K I Oliver ◽  
J Seo ◽  
N B Lasko ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbances ◽  
Traumatic Event ◽  
Behavioral Therapy ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Onset Latency ◽  
Wake Time ◽  
Sleep Diaries ◽  
Dsm 5

Abstract Introduction Hyperarousal and disturbed sleep are intrinsic symptoms of posttraumatic stress disorder (PTSD). We explored whether self-reported indices of hyperarousal predict longitudinally measured objective, subjective, and retrospective evaluations of sleep quality in trauma-exposed individuals. Methods Individuals exposed to a DSM-5 PTSD Criterion-A traumatic event within the past two years (N=130, 91 females), aged 18-40 (mean 24.43, SD 5.30), 51.54% of whom met DSM-5 criteria for PTSD, completed 14 days of actigraphy and sleep diaries. Participants also completed the PTSD Checklist for DSM-5 (PCL-5), the Clinician-Administered PTSD Scale (CAPS-5), published Hyperarousal (HAS) and Hypervigilance (HVQ) scales, and the Pittsburgh Sleep Quality Index (PSQI) (N=108-125 for different scales). Mean total sleep time (TST), sleep onset latency (SOL), sleep efficiency (SE) and sleep midpoint were calculated from actigraphy and subjective SOL, SE, number of awakenings, and time spent awake from diaries. Simple regressions were used to predict associations of the PCL-5, HAS, and HVQ scores with measures of sleep quality. Results Hyperarousal indices predicted diary but not actigraphy measures of sleep quality. Longer diary-reported SOL was predicted by higher scores for: PCL-5 total score (R=0.290, p=0.001), PCL-5 hyperarousal items without the sleep item (R=0.261, p=0.004), and HAS without sleep items (R=0.220, p=0.016). Diary-reported number of awakenings and wake time after sleep onset were predicted by higher HAS scores without the sleep question: (R=0.373, p<0.001; r=0.352, p<0.001). Similarly, all hyperarousal indices significantly predicted PSQI global score (PCL-5: R=0.482, p<0.001; PCL-5 hyperarousal: R=0.389, p<0.001; HVQ: R=0.214, p=0.017; HAS without sleep question: R=0.415, p<0.001). Conclusion Self-reported hyperarousal measures predict subjective longitudinal (especially SOL) and retrospective measures, but not objective measurements of sleep quality. Similar discrepancies between self-reported and objective measures of sleep quality have been reported in patients with insomnia disorder. Cognitive-behavioral therapy for insomnia may be especially effective in treating post-traumatic sleep disturbances. Support R01MH109638

775 The Relationship Between Sleep and Suicidal Ideation in College Students

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A301-A302
Author(s):  
Krishna Taneja ◽  
Andrew Tubbs ◽  
Fabian-Xosé Fernandez ◽  
Michael Perlis ◽  
Michael Grandner
Keyword(s):  
College Students ◽  
Suicidal Ideation ◽  
Suicide Risk ◽  
Severity Index ◽  
Interpersonal Theory ◽  
Thwarted Belongingness ◽  
Perceived Burdensomeness ◽  
Interpersonal Theory Of Suicide ◽  
Short Sleep ◽  
Sleep Control

Abstract Introduction Suicide is the second-leading cause of death for young adults and insomnia increases suicide risk. However, the data on disrupted sleep and suicidal ideation in college students is mixed, including whether disrupted sleep fits into the framework of the Interpersonal Theory of Suicide. Therefore, the present study explored how four different sleep variables influenced recent suicidal ideation in a collegiate sample. Methods Data from N=506 respondents were collected as part of the Assessing Nocturnal Sleep/Wake Effects on Risk of Suicide (ANSWERS) Survey in college students. The primary outcome, active suicidal ideation in the last 3 months, was assessed using several self-report questions derived from the Columbia Suicide Severity Rating Scale. The predictors were weekday short sleep (≤6h; assessed by retrospective sleep diary), Insomnia Severity Index (ISI) score, Brief Inventory of Sleep Control (BRISC) score, and Disturbing Dreams and Nightmares Severity Index (DDNSI) score. Binomial logistic regression models estimated the associations between suicidal ideation and sleep variables in models that were unadjusted, adjusted for age, sex, race, and ethnicity, and additionally adjusted for thwarted belongingness or perceived burdensomeness (constructs from the Interpersonal Theory of Suicide). Results A total of N=121 (23.9%) respondents endorsed suicidal ideation in the last 3 months. Individuals with suicidal ideation were in poorer health (p<0.001) and had more severe depression (p<0.001) and anxiety (p<0.001). In unadjusted models, individuals were more likely to report suicidal ideation if they had short sleep (OR 1.93 [1.23–3.05]), ISI scores of 8 or more (OR 3.01 [1.94–4.74]), and DDNSI scores of 10 or more (OR 2.66 [1.69–4.19]). Higher BRISC scores were associated with lower odds of suicidal ideation (OR 0.53 [0.41–0.68]). Adjusting for age, sex, race, ethnicity, thwarted belongingness, and perceived burdensomeness attenuated but did not eliminate any of these relationships. Conclusion Insomnia, short sleep, nightmares, and less perceived sleep control were all associated with recent suicidal ideation in college students. Moreover, these findings were generally independent of the Interpersonal Theory of Suicide. Further research is needed to understand how sleep affects suicide risk in this population, and whether sleep interventions can reduce this risk. Support (if any):

scholarly journals Validating Insomnia Severity Index (ISI) in a Bangladeshi Population: Using Classical Test Theory and Rasch Analysis

2021 ◽  
Vol 19 (1) ◽  
pp. 225
Author(s):  
Mohammed A. Mamun ◽  
Zainab Alimoradi ◽  
David Gozal ◽  
Md Dilshad Manzar ◽  
Anders Broström ◽  
...  
Keyword(s):  
Mental Health ◽  
Suicidal Ideation ◽  
Psychometric Properties ◽  
Classical Test Theory ◽  
Severity Index ◽  
Test Theory ◽  
Insomnia Severity Index ◽  
Classical Test ◽  
Rasch Analyses ◽  
Insomnia Severity

The COVID-19 outbreak is associated with sleep problems and mental health issues among individuals. Therefore, there is a need to assess sleep efficiency during this tough period. Unfortunately, the commonly used instrument on insomnia severity—the Insomnia Severity Index (ISI)—has never been translated and validated among Bangladeshis. Additionally, the ISI has never been validated during a major protracted disaster (such as the COVID-19 outbreak) when individuals encounter mental health problems. The present study aimed to translate the ISI into Bangla language (ISI-Bangla) and validate its psychometric properties. First, the linguistic validity of the ISI-Bangla was established. Then, 9790 Bangladeshis (mean age = 26.7 years; SD = 8.5; 5489 [56.1%] males) completed the Bangla versions of the following questionnaires: ISI, Fear of COVID-19 Scale (FCV-19S), and Patient Health Questionnaire-9 (PHQ-9). All the participants also answered an item on suicidal ideation. Classical test theory and Rasch analyses were conducted to evaluate the psychometric properties of the ISI-Bangla. Both classical test theory and Rasch analyses support a one-factor structure for the ISI-Bangla. Moreover, no substantial differential item functioning was observed across different subgroups (gender, depression status (determined using PHQ-9), and suicidal ideation). Additionally, concurrent validity of the ISI-Bangla was supported by significant and moderate correlations with FCV-19S and PHQ-9; known-group validity was established by the significant difference of the ISI-Bangla scores between participants who experienced suicidal ideation and those without. The present psychometric validation conducted during the COVID-19 outbreak suggests that the ISI-Bangla is a promising and operationally adequate instrument to assess insomnia in Bangladeshis.

scholarly journals Current Research on Suicide in Older Adults

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 525-526
Author(s):  
Montgomery Owsiany ◽  
Yeates Conwell
Keyword(s):  
Older Adults ◽  
Suicidal Ideation ◽  
Older Adult ◽  
Suicide Risk ◽  
Medical Center ◽  
Late Life ◽  
Well Being ◽  
Future Research ◽  
Younger Adults ◽  
Suicidal Thoughts And Behaviors

Abstract Rates of suicide are elevated in middle- and late-life, yet studies focusing on suicidal ideation and behavior in older adults are limited compared to research in younger adults. The studies included in the present symposium offer valuable findings on suicide in older adults across the span of late-life. Owsiany et al. focus on age differences between older and younger adults in the association between anxiety symptoms and suicide risk. In Heisel et al., an online intervention is assessed for improving the outcomes of psychological well-being and suicide risk in older adult men who are transitioning into retirement during the COVID-19 pandemic. Crnek-Georgeson and Wilson reviewed the link between retirement patterns and psychological effects, including suicidal behaviors, among older adults. Additionally, this review includes recommendations for policy makers and employers in an effort to assist older adults with the transition into retirement. Utilizing baseline data from the Helping Older Adults Engage study, Fenstermacher et al. research the association between volunteering and suicidal ideation in a predominantly lonely older adult sample across the span of late-life. Together, these studies provide foundation for future research on suicide in late-life to build upon. Future studies should continue to focus on risk and protective factors for suicide in older adults and aim to improve screening and intervention for suicidal thoughts and behaviors in this population. Yeates Conwell, M.D., Director of Geriatric Psychiatry and Co-Director of the Center for the Study and Prevention of Suicide at the University of Rochester Medical Center, will serve as discussant.

scholarly journals 647 Adolescent and Young Adult Sleep and Sleep-Related Behaviour Change During the COVID-19 Pandemic

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A253-A253
Author(s):  
Nicole Carmona ◽  
Colleen Carney
Keyword(s):  
Sleep Disturbance ◽  
Behaviour Change ◽  
Technology Use ◽  
Sleep Time ◽  
Adolescent And Young Adult ◽  
Poor Sleep ◽  
Negative Effects ◽  
Wake Time ◽  
Sleep Diaries ◽  
Time In Bed

Abstract Introduction Sleep disturbance, poor sleep quality, and dissatisfaction with sleep are common among adolescents and young adults (AYAs; e.g., Becker et al., 2018; Hicks et al., 2002; Hysing et al., 2013). Environmental and behavioural factors (e.g., early school start times, evening technology use and social pressures) are barriers to healthy sleep among AYAs that contribute to a “perfect storm” of sleep disturbance during this period (Carskadon, 2011; Crowley et al., 2018). Notwithstanding, few AYAs have access to sleep treatments. The COVID-19 pandemic lockdowns decreased academic and scheduling demands, providing an opportunity to study unconstrained AYA sleep and potentially facilitating better access to sleep interventions (Simpson & Manber, 2020). This study evaluated differences in baseline sleep and sleep-related behaviour change (i.e., how AYAs use an evidence-based app for sleep disturbance) before vs. during the lockdown. Methods Participants between the ages of 15 and 24 (M=20.66, SD=2.38) completed a 4-week feasibility study evaluating a free, transdiagnostic sleep self-management app (DOZE) before the lockdown (“Pre-Lockdown”; n=51) or during the lockdown (“Lockdown”; n=29). After 2 weeks of completing baseline sleep diaries, participants could set goals based on feedback and access tips, followed by 2 more weeks of completing sleep diaries. Results Compared to Pre-Lockdown, Lockdown demonstrated less variability in their sleep schedules (ps≤.011), less napping (p=.002), but increased time in bed (TIB; p<.001) and total wake time (p=.007). Total sleep time, lingering in bed in the morning, and sleep efficiency did not differ between groups. Relative to Pre-Lockdown, Lockdown showed a greater tendency to set goals to reduce schedule variability (p=.010) and to restrict excessive TIB (p=.005). Rates of goal setting for lingering in bed in the morning, sleepiness, naps, and sleep-interfering substance use did not differ between groups. Rates of accessing tips did not differ between groups. Conclusion Effects of COVID-19 lockdown on AYA sleep included less variability in their schedule and a decreased need for naps, but negative effects on TWT and TIB. As a result, AYAs set different goals during the COVID-19 lockdowns, focusing more on restricting excessive TIB than on schedule variability. Support (if any) Canadian Institutes of Health Research eHealth Innovation Partnership Program (#143551).

338 How Much Improvement in the Insomnia Severity Index Is Associated With a Positive Impact of A Patient’s Insomnia Medication?

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A135-A135
Author(s):  
William Lenderking ◽  
Yulia Savva ◽  
Isabelle Chabot ◽  
Genevieve Meier ◽  
Jane Yardley ◽  
...  
Keyword(s):  
Total Sleep Time ◽  
Severity Index ◽  
Sleep Time ◽  
Double Blind Study ◽  
Negative Effects ◽  
Double Blind ◽  
Insomnia Severity Index ◽  
Positive Effects ◽  
Falling Asleep ◽  
Insomnia Severity

Abstract Introduction In Phase 3 Study 304 (SUNRISE-1; NCT02783729) and Study 303 (SUNRISE-2; NCT02952820), lemborexant (LEM) provided significant benefit versus placebo on sleep diary-based sleep onset/maintenance outcomes over 1mo and 6mo, respectively, in subjects with insomnia disorder. Both studies included the Insomnia Severity Index (ISI) and the Patient Global Impression–Insomnia version (PGI-I). On the PGI-I scale, subjects assess positive, neutral or negative treatment impact on falling asleep, overall benefit on sleep, and total sleep time. Using an anchor-based approach, ratings were compared with mean changes in ISI scores from baseline to evaluate what would be considered a responder definition on the ISI. Methods Study 304 was a 1mo, randomized, double-blind, placebo- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006); subjects received placebo, LEM 5mg, LEM 10mg, or zolpidem tartrate extended-release. Study 303 was a 12mo, randomized, double-blind study in subjects age ≥18y (n=950). Subjects received placebo, LEM 5mg, or LEM 10mg for 6mo. Data from both studies were pooled for the first month of treatment across all treatment groups. A modified ISI total score (ISI-ts) was used based on a confirmatory factor analysis that showed no incremental value to including Question 5 (How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of your life?). Results The ‘Overall Sleep’ PGI-I item demonstrated that mean [SD] changes from baseline in ISI-ts decreased more in association with self-reported positive effects (−8.15 [4.98]) than for neutral (−3.59 [3.37]) or negative effects (−1.67 [2.91]) at Day 31/Month 1. For PGI-I Item ‘Time to Fall Asleep,’ mean (SD) changes from baseline in ISI-ts were −7.49 (5.10) for positive, −4.54 (4.13) for neutral, and −2.94 (4.04) for negative effects at Day 31/Month 1. For PGI-I Item ‘Total Sleep Time’ mean (SD) changes from baseline in ISI-ts were −8.15 (5.04) for positive, −3.74 (3.23) for neutral, and −2.40 (3.49) for negative effects at Day 31/Month 1. Conclusion Results of this anchor-based approach using the PGI-I suggest that the responder definition for ISI-ts, using the modified ISI, should be approximately −8 points. Support (if any) Eisai Inc.

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