Sleeping Pill Risks May Outweigh Benefits In Older Patients

TORONTO, Nov. 11-For insomnia patients 60 or older, the risk of dizziness or falls caused by sleeping pills may outweigh the benefits, according to a meta-analysis reported by investigators here.
Action Points
Consider alternatives to pharmacologic therapy for insomnia in older patients, such as cognitive behavioral therapy.In fact, older adults were more than twice as likely to suffer an adverse event as they were to experienced improved sleep, reported Usoa E. Busto, Pharm. D., of the Center for Addiction and Mental Health here in a study published online in the British Medical Journal.
However, this finding should be used as a "rough indicator only," as the meta-analysis included much more data on adverse events than on effectiveness, the study authors said.
The meta-analysis included 24 randomized, placebo-controlled studies done between 1996 and 2003. These studies included 2,417 participants 60 or older with insomnia but otherwise free of psychiatric or psychological disorders. In these studies, sleeping pills were taken for at least five and as many as 21 consecutive nights.
A total of 830 patients were treated with benzodiazepines, 106 with Imovane (zopiclone), 384 with Ambien (zolpidem), 609 with Sonata (zaleplon), 14 with the antihistamine diphenhydramine, and 468 with placebo.
The meta-analysis compared potential benefits (subjective reports of sleep variables) with cognitive adverse events (memory loss, confusion, disorientation); psychomotor adverse events (dizziness, loss of balance, falls); and residual morning sedation.
Overall, sleep quality improved 14% (P0.05), which the researchers calculated had a small effect size. Total sleep time improved by an average of about 25 minutes (P0.001), and the number of nighttime awakenings decreased by 63% (P0.001).
Adverse events were more common with sleep aids than placebo. Adverse cognitive events were 4.78 times more common (95% confidence interval=1.47-15.47; P0.01). Adverse psychomotor events were 2.61 times more common, although this did not reach statistical significance (95% CI=1.12-6.09; P >0.05). Residual daytime sedation was 3.82 times more common (95% CI=1.88-7.80; P0.001).
The researchers calculated that the number needed to treat for improved sleep quality was 13, while the number needed to harm for any adverse event was six. "This ratio indicates that an adverse event is more than twice as likely as enhanced quality of sleep," the study authors said.
"Although the improvements in sleep variables obtained from prescription sedative hypnotics are statistically significant, the effect size is small, and the clinical benefits may be modest at best," the researchers concluded.
"The added risk of an adverse event may not justify these benefits, particularly in a high risk elderly population. These factors should be considered when sedative hypnotics are prescribed for older patients," they advised.
Cognitive behavioral therapy has been shown to be as effective as pharmacotherapy for insomnia in older people, the investigators noted. Because fewer risks are associated with behavioral therapy, it may be a viable treatment alternative in a healthy elderly population with no cognitive impairment, the researchers suggested.
Some limitations of the study pointed out by the authors included the fact that "all sedatives or all benzodiazepines were grouped together for analyses, irrespective of differences in half life, potency, or dosage." Also, no standard method of collecting subjective sleep variables is available.Primary source: British Medical JournalSource reference: Glass J et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. British Medical Journal. Advanced online publication November 10, 2005.