#Acute insomnia causes older adults trial#

Here again, they found that treatment groups significantly differed from the placebo group but not from each other. Interestingly, Rosenberg et al 4 used an Insomnia Severity Index factor score for the evaluation of daytime functioning (ie, sum of items 4-7). The treatment groups significantly differed from the placebo group but not from each other. The mean changes in scores were −6.1 points in the placebo group, −8.3 points in the zolpidem group, −7.8 points in the lemborexant 5 mg group, and −7.9 points in the lemborexant 10 mg group. Specific subjective data were presented using the Insomnia Severity Index. Absent these data, one cannot know how the variables that represent the patients’ presenting concerns were affected. Of note, if not concern, is that sleep diary values for SL and WASO were assessed and reported to be statistically improved, but the specific values were not reported. As for treatment-emergent adverse events, the authors reported that the “overall incidence of treatment-emergent was similar among treatment groups.” 4 Both doses of lemborexant produced significantly larger effects for polysomnographically measured SL and WASO than zolpidem. When evaluated by time of night (ie, change to WASO in the second half of the night) the reductions were 7.1 minutes in the placebo group, 24.6 minutes in the zolpidem group, 30.3 minutes in the lemborexant 5 mg group, and 37.1 minutes in the lemborexant 10 mg group. Compared with a 15.1-minute reduction in WASO in the placebo group, the zolpidem group had a 44.4-minute reduction, the lemborexant 5 mg group had a 50.0-minute reduction, and the lemborexant 10 mg group had a 59.6-minute reduction. Compared with a 6.5-minute decrease in polysomnographic SL in the placebo group, patients treated with zolpidem exhibited a reduction in polysomnographic SL of 12.6 minutes, and patients treated with lemborexant demonstrated reductions of 16.6 minutes for the 5-mg dose and 19.5 minutes for the 10-mg dose. The primary outcomes of the study were polysomnographic sleep latency (SL) and WASO. It is important to note that the study also ruled out placebo responders during baseline.

#Acute insomnia causes older adults trial#

Rosenberg et al 4 present data from a placebo-controlled randomized clinical trial that evaluated 2 different doses of lemborexant compared with extended-release zolpidem in older adults with severe sleep maintenance difficulties (ie, wake-after-sleep-onset mean of ≥60 minutes on ≥3 nights per week for the past month and a polysomnographic mean WASO of ≥60 minutes across 2 laboratory studies).

The study by Rosenberg and colleagues 4 does precisely this. 3 Given the promise and potential of dual orexin receptor antagonists, it is especially important that these compounds be specifically evaluated in older adults in a manner that allows for the assessment of the efficacy and safety of this new therapeutic modality compared with standard treatments, especially with benzodiazepine receptor agonists. This new class of medications holds the promise of greater efficacy, as the target mechanism may more directly address the issue of the failure to inhibit wakefulness, and the potential for reduced adverse effects, especially in the domain of cognition, memory, and psychomotor behavior. More recently, a new class of pharmacologic agents, dual orexin receptor antagonists, has been developed, evaluated, approved, and introduced into prescriptive formularies. These include on-label approaches (eg, melatonin agonists, such as ramelteon) and off-label approaches (eg, sedating antidepressants, such as trazodone). 2 This being the case, other medications tend to be prescribed for older adults. Of the pharmacologic agents indicated for the treatment of insomnia disorder, nearly all of which are γ-aminobutyric acid agonists, most are associated with significant risks for use in older adults. This is true for a variety of reasons, including the unavailability of clinicians who can provide cognitive behavioral therapy for insomnia, the universal availability of pharmacotherapy, and the reduced time commitment and behavioral work required by pharmacotherapy.

While the recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia, 1 most patients will be offered or opt for medical management of their insomnia. Accordingly, treating insomnia should be a priority, especially among older adults, as this group is at increased risk for sleep continuity disturbance (ie, problems with sleep initiation, maintenance, and duration). Insomnia, even when variably defined, is a well-established risk factor for impaired daytime functioning, unhealthy substance use, depression, other psychiatric disorders, chronic pain, and a variety of other medical conditions, including obesity, high blood pressure, cardiovascular disease, and dementia.