Glass · BMJ (Clinical research ed.) 2005 · systematic review and meta-analysis · n=24 studies (2417 participants)

Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits.

Cited 1160 times in the scientific literature.

Level 1 - systematic review of randomized trials

Systematic review and meta-analysis of randomized controlled trials

PubMed 16284208 · doi:10.1136/bmj.38623.768588.47 · record verified 2026-08-31

What was done

A systematic review and meta-analysis evaluated randomized controlled trials (1966–2003) comparing short-term pharmacological treatment (at least five consecutive nights) versus placebo in individuals aged 60 or older with insomnia and no comorbid psychiatric or psychological disorders. Outcomes analyzed were subjective sleep variables, adverse events, and morning-after psychomotor impairment.

What was found

Across 24 studies (2,417 participants), sedative hypnotics yielded statistically significant but small sleep improvements compared to placebo: sleep quality effect size was 0.14 (P < 0.05), total sleep time increased by a mean of 25.2 minutes (P < 0.001), and night-time awakenings decreased by 0.63 (P < 0.001). Adverse events were more common with sedatives: adverse cognitive events were 4.78 times more common (95% CI 1.47 to 15.47, P < 0.01), daytime fatigue was 3.82 times more common (95% CI 1.88 to 7.80, P < 0.001), and adverse psychomotor events were 2.61 times more common (95% CI 1.12 to 6.09, P > 0.05).

Why it matters

In patients over 60, the modest subjective benefit of sedative hypnotics is accompanied by substantial increases in cognitive and psychomotor adverse events, suggesting the harms may not justify the benefits in populations at risk for falls and cognitive impairment.

Limits

The review only evaluated short-term trials and excluded patients with comorbid psychiatric conditions. Sleep outcomes were limited to subjective reports rather than objective polysomnography, and confidence intervals for several adverse event categories were relatively wide.

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