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Sleeping Pills: Risks vs. Benefits for Older Patients

November 15, 2005

For elderly patients, the health risks posed by taking sleeping pills may outweigh the benefits, according to a new meta-analysis of data. The study showed that people aged 60 years or older with insomnia who took sleeping pills reported falls or dizziness more than twice as often as they reported improved sleep.

Because the meta-analysis included notably more data on adverse events than on drug effectiveness, the researchers cautioned that their findings should be use as a "rough indicator only."

Study Results

Busto and colleagues examined data from 24 randomized, placebo-controlled studies done in the period 1996-2003. The studies included 2,417 participants aged 60 years or older who had insomnia but no other psychological or psychiatric disorders.

Study participants received sleeping pills or placebo for 5-21 consecutive nights, as follows: 830 participants received benzodiazepines, 106 received Imovane (zopiclone), 384 received Ambien (zolpidem), 609 received Sonata (zaleplon), 14 received diphenhydramine (an antihistamine) and 468 received placebo.

The meta-analysis compared potential benefits (subjective reports of sleep variables) and risks (adverse events, including memory loss, confusion and disorientation, and psychomotor impairment, including dizziness, loss of balance and falls). Residual morning sedation was also measured.

Results showed that, overall, sleep quality significantly improved (14%; P<0.05), although the researchers noted that the magnitude of the effect was small. Total sleep time also significantly improved (by about 25 minutes on average; P<0.001) and the frequency of waking at night significantly decreased (63%; P<0.001).

Adverse events were reported more often among participants receiving sleeping pills: adverse cognitive events occurred 4.78 times more often (P<0.01); adverse psychomotor events occurred 2.61 times more often, but were not statistically significant (P>0.05); and residual morning-after sedation occurred 3.82 times more often (P<0.001).

The researchers calculated that the number of participants needed to treat for improved sleep quality was 13 and the number needed to harm for any adverse event was 6, concluding that "this ratio indicates that an adverse event is more than twice as likely as enhanced quality of sleep."

Busto and colleagues also noted that "[a]lthough 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 added risk of an adverse event may not justify these benefits, particularly in a high risk elderly population."

In conclusion, they also observed that non-pharmacological sleep therapies, such as cognitive behavior therapy, have been shown to be as effective as sleep-enhancing drugs for insomnia in older people. Because these therapies carry fewer associated risks, they may be more suitable for older people with no cognitive impairment.

Study limitation included the fact that "all sedatives or all benzodiazepines were grouped together for analyses, irrespective of differences in half life, potency, or dosage," and that no method exists to collect sleep variables in a subjective fashion.

Sleeping Pill Risks May Outweigh Benefits In Older Patients, MedPage Today, 11 November 2005.
Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits, Glass J et al. British Medical Journal online, 11 November 2005.

Posted: November 2005