LONG-TERM SAFETY AND EFFICACY OF DOXEPIN FOR ELDERLY INSOMNIA Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia

1553 Efficacy and Safety of Doxepin in Elderly Insomnia Patients—Krystal et al INSOMNIA IS DEFINED AS DIFFICULTY INITIATING SLEEP, MAINTAINING SLEEP, AND/OR NONRESTORATIVE SLEEP ACCOMPANIED BY DAYTIME impairments.1 Although, not found in all studies, many investigations have found that the risk of insomnia increases with age.2-6 Insomnia has also been reported to be more severe in the elderly.2 Older adults with insomnia awaken more frequently and spend a greater percentage of their nights awake than do non-elderly adults with insomnia.2 While insomnia is associated with decreased quality of life and impairment in function in general, there are some concerning consequences that are specific to the elderly, including increased risk of falls and nursing home placement.7-9 The greater severity and consequences of insomnia in older adults speak to the need for developing effective insomnia treatments for this population. Unfortunately, fewer studies of pharmacologic insomnia therapy have been conducted in this population relative to younger adults.10 In this regard, data are notably lacking on the benefit of insomnia treatment in the elderly. Evidence to support extended treatment is especially important for older adults as they appear to be more susceptible to developing chronic insomnia.6,11,12 In a study of elderly general practice patients, 57% met diagnostic criteria for insomnia, with 80% of these patients reporting insomnia duration of greater than 1 year.13 However, there is a corresponding increase in the duration of pharmacotherapy for insomnia with age,14-16 and there are no studies which provide an indication of the safety or efficacy of this practice for any agents.10 Indeed, there have been only 3 large, double-blind, placebo-controlled published trials evaluating the efficacy of any insomnia agent for more than 5 weeks, and none of these trials were conducted in the elderly.17-19 Although the present study does not fully address this deficiency, it is of importance as it is the longest PSG trial of the efficacy and safety of insomnia pharmacotherapy in the elderly. The inclusion of PSG outcome assessment addresses concerns related to the adequacy of blinding and the effects of differential dropout that have been raised because of the lack LONG-TERM SAFETY AND EFFICACY OF DOXEPIN FOR ELDERLY INSOMNIA