Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials.

OBJECTIVE: Suvorexant is an orexin receptor antagonist approved for treating insomnia at doses of 10-20 mg. Previously reported phase III results showed that suvorexant was effective and well-tolerated in a combined-age population (elderly and nonelderly adults). The present analysis evaluated the clinical profile of suvorexant specifically in the elderly. METHODS: Prespecified subgroup analyses of pooled 3-month data from two (efficacy) and three (safety) randomized, double-blind, placebo-controlled, parallel-group trials. In each trial, elderly (≥65 years) patients with insomnia were randomized to suvorexant 30 mg, suvorexant 15 mg, and placebo. By design, fewer patients were randomized to 15 mg. Patient-reported and polysomnographic (subset of patients) sleep maintenance and onset endpoints were measured. RESULTS: Suvorexant 30 mg (N = 319) was effective compared with placebo (N = 318) on patient-reported and polysomnographic sleep maintenance, and onset endpoints at Night 1 (polysomnographic endpoints)/Week 1 (patient-reported endpoints), Month 1, and Month 3. Suvorexant 15 mg (N = 202 treated) was also effective across these measures, although the onset effect was less evident at later time points. The percentages of patients discontinuing because of adverse events over 3 months were 6.4% for 30 mg (N = 627 treated), 3.5% for 15 mg (N = 202 treated), and 5.5% for placebo (N = 469 treated). Somnolence was the most common adverse event (8.8% for 30 mg, 5.4% for 15 mg, 3.2% for placebo). CONCLUSION: Suvorexant generally improved sleep maintenance and onset over 3 months of nightly treatment and was well-tolerated in elderly patients with insomnia (clinicaltrials.gov; NCT01097616, NCT01097629, NCT01021813).

Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data.

RATIONALE: Sex-related differences in the clinical profiles of some insomnia medications have been previously reported. OBJECTIVE: To evaluate the clinical profile of suvorexant, a novel orexin receptor antagonist approved for treating insomnia at doses up to 20 mg, by sex subgroups. METHODS: Efficacy analyses by sex were based on pooled data from two similar phase 3, randomized, double-blind, placebo-controlled, 3-month trials in elderly (≥65 years) and non-elderly (18-64 years) insomnia patients. Two age-adjusted (non-elderly/elderly) dose regimes of 40/30 and 20/15 mg were evaluated, with fewer patients assigned to 20/15 mg. Efficacy was assessed by patient-reported outcomes (N = 1264 women, 707 men) and by polysomnography endpoints in ~75% of patients. Safety analyses by sex (N = 1744 women, 1065 men) included pooled data from the two 3-month trials plus 3-month data from a safety trial of 40/30 mg. RESULTS: The sex subgroup efficacy analyses mirrored the improvements seen for suvorexant 40/30 and 20/15 mg over placebo on patient-reported outcomes and polysomnography sleep maintenance and onset endpoints in the primary analyses; 95% CIs excluded zero in favor of suvorexant for most endpoints in both sexes, and similar efficacy was observed between sexes (95% CIs overlapped). Suvorexant was well-tolerated in women and men, although women in all treatment groups (including placebo) reported more adverse events than men. The most frequent adverse event was somnolence (women: 11.1% for 40/30 mg, 8.5% for 20/15 mg, 2.3% for placebo; men: 10.1% for 40/30 mg, 3.4% for 20/15 mg, 4.2% for placebo). CONCLUSION: Suvorexant was generally effective and well-tolerated in both women and men with insomnia. ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629, NCT01021813.

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.

STUDY OBJECTIVES: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. METHODS: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. RESULTS: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use. CONCLUSIONS: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629.

Evaluation of mental health emergency preparedness among health professionals.

The purpose of this study was to identify if health professionals report an increase in mental health preparedness abilities with having only two mental health components as part of a 2-day preparedness training conference. At each of three conferences, identical pretraining and posttraining surveys were administered to conference participants. A 3-month follow-up survey was administered to respondents who volunteered to complete them. At pretraining, respondents (n = 603) reported generally greater mental health preparedness abilities than non-mental health preparedness abilities. This trend continued at posttraining (n = 490) and at 3 months posttraining (n = 195). Participants reported significantly increased mental health preparedness abilities at immediate posttraining and at 3 months posttraining from pretraining. This current study suggests that even when mental health items are included as a secondary component of disaster preparedness training, significant and meaningful growth in participants' confidence in their abilities can occur.

Public health investigation: focus group study of a regional infectious disease exercise.

BACKGROUND: Local health departments and public health nurses are crucial in surveillance and response during public health emergencies. Simulated exercises are useful to train personnel and test emergency preparedness plans, but these exercises can be inconvenient or unrealistic. To address these drawbacks, "Public Health Investigation" (PHI), a multicounty, electronic infectious disease exercise, was created. METHODS: After the 4-week PHI exercise, 6 separate focus groups and 1 regional focus group were conducted with participating health departments to explore perceptions of whether the format was useful, how to improve future exercises, and how well exercise objectives were met. RESULTS: Counties reported improvements in all exercise objectives, especially surge capacity and coordination between counties. Small health departments requested state assistance with risk communication. Existing protocols and procedures were reported as helpful. Suggested improvements to the exercise format included a shorter, 3-week exercise, interviews with mock patients, pertinent scene information provided with scene questions, instruction on technology used, and clarifications to the "Rules of the Game." CONCLUSIONS: Participants indicated that the format of the PHI exercise was successful in addressing exercise objectives. Increased regional collaboration may be the greatest strength of an exercise of this format.

"Public health investigation": a pilot, multi-county, electronic infectious disease exercise.

INTRODUCTION: Funding increases after September 11, 2001 have provided impetus to improve public health emergency preparedness plans. Training of local health department staff and coordination between counties are important components of these plans. Electronic media have been used to facilitate dissemination of training, and a need for evaluation has been identified. METHODS: Public Health Investigation (PHI) was conducted in 6 Kansas counties during February 2005 in an electronic, in-office format. The quantitative evaluation consisted of pre- and postsurveys. Questions measured self-reported improvements in 4 areas: surge capacity, coordination between counties, risk communication, and protocols and procedures. RESULTS: Although all 4 areas showed improvement, 2 showed statistically significant improvement. At the postsurvey, participants reported significantly improved abilities to (1) participate in a coordinated, multidisciplinary response to an infectious disease outbreak (P = .003) and (2) identify the need for and implement surge capacity (P = .017). CONCLUSIONS: Increased collaboration between counties and partner agencies may be the greatest strength of PHI, a multi-county, real-time exercise. This format strengthens regional bonds and is cost-effective. The PHI may be a useful model for other states wishing to use a regional approach for training, thereby strengthening regional bonds.

Pattern and frequency of use of complementary and alternative medicine among patients with epilepsy in the midwestern United States.

Complementary and alternative medicine (CAM) is recognized to be commonly used by patients, yet there have been few studies regarding the scope of CAM use by patients with epilepsy. This study assessed usage and perceptions of CAM by patients with epilepsy in the midwest of the United States. A 25-item survey was administered to adult patients with epilepsy, and data were collected from 228 patients. The survey collected demographics, specific CAM usage, adverse effects of CAM therapy, and perceptions of the effectiveness of CAM. Thirty-nine percent reported using CAM; 25% reported using CAM specifically for their epilepsy. Prayer/spirituality was the most commonly used form of CAM (46%), followed by "mega" vitamins (25%), chiropractic care (24%), and stress management (16%). CAM use is common among midwestern patients with epilepsy, although the pattern of use may be slightly different than in other regions of the United States and elsewhere.

Preparedness needs assessment in a rural State: themes derived from public focus groups.

Recent studies have assessed preparedness training and the resource needs of public health and clinical professionals in responding to a crisis, but few have assessed the needs of the general public, especially in rural areas. The present study, based in a risk assessment and information-seeking theoretical framework, assessed the preparedness awareness, knowledge, and attitudes of the general public in a rural state through a series of focus groups. Six focus groups were conducted with 34 participants in 4 locations in Kansas (2 urban and 2 rural). Focus group interviews followed a standardized script. Participants from all 4 locations reported training and knowledge needs and desired training, knowledge, and emergency preparedness plans. Certain groups also reported a lack of familiarity with preparedness terminology, as well as different ideas about trusted sources and agencies responsible for providing preparedness training or information. Some diverging opinions from these focus groups were stratified by urban/rural status, indicating possible implications for future all-hazards training in rural regions of the nation. These results may be used for planning and improving training for the general public in both urban and rural areas.

Evaluation of interdisciplinary terrorism preparedness programs: a pilot focus group study.

Many terrorism preparedness trainings occur throughout the United States, yet few qualitatively examine trainees' needs and interests, reactions to training, or suggestions for training improvement. Eleven posttraining focus groups were conducted with 31 training participants at six sites. Participants were stratified by health profession discipline, and discipline-specific moderators conducted each session to better understand and probe for feedback. One additional moderator attended all sessions to increase consistency in methods across sessions. Focus group participants assessed changes in their perceptions, knowledge, and beliefs about terrorism preparedness. Participants reported perceiving terrorism as a potential threat but less likely than natural disasters. All-hazards crossover training for responding to terrorism and natural disasters was requested. The training was viewed positively, including the enrollment process, training content, and reference materials. Participants reported increased confidence in abilities to recognize a terrorist event. Participants stated they would like the training repeated annually with more first responders in attendance. Participants from rural areas had unique training needs based on limited resources and multiple roles of staff. While most participants wanted a longer, multispecialty conference with in-depth, discipline-specific breakout sessions, physicians requested shorter, separate training. Multispecialty training methods were successful and appreciated. This pilot study may serve as a template for qualitative evaluation of terrorism preparedness conferences for health professionals.