Non-benzodiazepine hypnotics provide slight benefit in insomnia

Non-benzodiazepine hypnotics help adults with insomnia fall asleep slightly sooner, a new meta-analysis found.

Researchers used data from 13 double-blind, placebo-controlled trials submitted to the FDA. The studies included three drugs (eszopiclone, zaleplon and zolpidem), 65 different drug-placebo comparisons and more than 4,000 participants. Results were published in the Jan. 2 print issue of BMJ and online Dec. 17, 2012.

In the meta-analysis, the drugs were associated with statistically significant, but slight, improvements in the time it took to fall asleep. According to polysomnography, participants fell asleep 22 minutes sooner (95% CI, 11 to 33 minutes) on the drugs than placebo, and subjective reports from patients showed a perceived benefit of seven minutes of sleep latency reduction from the drugs. Not enough data were collected on secondary outcomes for the analysis to draw firm conclusions.

The researchers did find that more benefit was seen in studies that included zolpidem, were published earlier, used larger doses, had longer duration of treatment, and had more younger and/or female patients. They also noted that a strong placebo response was found in the studies: If both the drug effect and placebo effect were included, participants fell asleep an average of 42 minutes sooner.

These findings indicate that placebo response may be a major contributor to the effectiveness of these drugs, the authors concluded. The small effect achieved by the drugs alone should be balanced against the harms of the drugs (including adverse effects, tolerance and addiction), which were not considered in this analysis, they concluded.

An accompanying editorial recommended that cognitive and behavioral therapy for insomnia be considered either in place of or in combination with pharmaceutical treatments. The findings “highlight the need to reduce reliance on hypnotic drugs as sole treatments for insomnia,” the editorialist said.