Risk-benefit relationship of sedative-hypnotics in elderly individuals with insomnia.

Description

These studies evaluated the risk-benefit of sedative-hypnotics in elderly individuals with insomnia. A meta-analysis was performed to determine the pooled benefits (i.e. subjective sleep parameters) and risks (i.e. adverse events) in healthy elderly. A clinical comparison was performed comparing subjective outcome measures (sleep quality, total sleep time, number of awakenings, time spent awake in the night) of 15mg temazepam and 50mg diphenhydramine. Quality of life analysis and patient satisfaction were assessed in the clinical analysis. Results from all studies indicate improvement in subjective sleep parameters with sedative-hypnotics with small magnitudes of effect. Results from the meta-analysis indicate a mean improvement in sleep quality of d = 0.14, total sleep time 25.2 minutes, and 0.63 fewer nighttime awakenings with sedative-hypnotic treatment (p<0.05, 0.01, and 0.0001, respectively). In the clinical study, improvements were seen with 15mg temazepam on sleep quality, total sleep time, number of awakenings and sleep onset latency (p<0.05, all). There were no improvements over placebo seen with diphenhydramine. Adverse events in the meta-analysis were more common than placebo control; this was not the case in the clinical study. The odds ratio for cognitive adverse events was 4.89, a psychomotor event was 2.61, daytime fatigue was 3.82 (p<0.01, NS, p<0.01, respectively). In the clinical study there were no differences in the numbers of adverse events reported after treatments compared to placebo. There was a trend towards improvement in social functioning component of the quality of life analysis. Subjects were willing to pay more for temazepam treatment than diphenhydramine or placebo (p<0.05), and this was correlated to improvements in subjective sleep quality. In conclusion, although sedative-hypnotics do improve subjective measures of sleep, the effects are small. Diphenhydramine 50mg is less effective than temazepam 15mg for short-term treatment of insomnia, but more effective than placebo (NS). Despite the small magnitudes of effect, elderly individuals with insomnia were willing to pay more for sleep medications than for placebo, indicating satisfaction with treatment.

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