Zolpidem and Cognitive Behavioral Therapy for Insomnia in Older Adults

California Pacific Med Ctr Res Institute, San Francisco CA

Investigators

Abstract

DESCRIPTION (provided by applicant): This one-year grant will support planning activities for a 12-month, multi-center randomized trial in which older adults with insomnia will be randomized to one of three treatment arms: 1) zolpidem;2) cognitive behavioral therapy for insomnia (CBT-I) or 3) placebo. The overall goal during the planning phase is to complete all of the scientific planning and administrative activities required to support a proposal for a randomized trial. Older adults are particularly susceptible to insomnia, which may be influenced by a variety of factors including medical comorbidities, depression and anxiety, and polypharmacy. There is growing evidence that sleep disturbances may accelerate the aging process, increasing risks for a variety of diseases and conditions such as falls, poor cognitive and physical function, and cardiovascular disease. It is uncertain, however, if successful treatment of insomnia will influence risk for these outcomes because randomized trials are not designed or powered to test these hypotheses. Zolpidem, a commonly used hypnotic medication (in the non-benzodiazepine benzodiazepine receptor agonist class), has been shown to be effective in older adults in short-term trials. Like other hypnotics, while zolpidem has been indicated only for short-term use, quite often it is prescribed over an extended period of time. Long-term treatment trials in older adults are needed to demonstrate safety and efficacy of commonly used hypnotics. Behavioral approaches to treating insomnia such as CBT-I have demonstrated efficacy in older adults and may offer advantages over pharmaceutical interventions. However, these approaches are underutilized, and there is little comparative data on efficacy of CBT-I versus pharmaceutical interventions, especially over the long term. Therefore, we propose this one year planning grant to develop a proposal for a randomized trial designed to test the following specific aims: 1) To compare the short- and long-term safety and efficacy of zolpidem, CBT-I, and placebo in older adults with insomnia;2) To compare the effects of zolpidem versus CBT-I versus placebo on risk of falls and poor physical performance;3) To test the effects of treatment assignment on neuropsychiatric function;and 4) To test the effects of treatment assignment on risk for hypertension. Results from this trial are essential to inform treatment recommendations for older adults with insomnia.