Boston—Disturbed sleep doesn’t appear to be ameliorated by use over the longer term of prescription medications for insomnia, according to an observational study.

The report in BMJ Open found no difference in sleep quality or duration in middle-aged women whether they took insomnia medications for 1 to 2 years or not.

The findings are important, according to Brigham and Women Hospital/Harvard Medical School–led researchers, because about 9 million adults in the United States use prescription drugs for sleep. Among those drugs are benzodiazepines and “Z-drugs,” which include zolpidem, zaleplon, and eszopiclone.

The women participated in the Study of Women’s Health Across the Nation (SWAN), a long-term multicenter study looking at biological and psychosocial changes arising during the menopause. The women’s average age was 49.5 years and around half were white.

For the study, 238 new users of prescription sleep medications were propensity-score matched to 447 women not starting sleep medications. The study team tracked self-reported sleep disturbance during the previous 2 weeks—difficulty initiating sleep, waking frequently, and early morning awakening—using a five-point Likert scale, ranging from no difficulty on any night (rating 1) to difficulty on five or more nights a week (rating 5).

Sleep disturbances then were compared at 1 year—defined as the primary outcome—and at 2 years of follow up.

At baseline, sleep disturbance ratings were similar, according to the researchers; medication users had a mean score for difficulty initiating sleep of 2.7 (95% CI, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and early-morning awakening 2.8 (95% CI, 2.6-3.0); nonusers’ ratings were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.9), and 2.7 (95% CI, 2.6-2.8), respectively.

Results indicate that, after the first year, ratings for medication users were 2.6 (95% CI, 2.4-2.8) for initiating sleep, 3.6 (95% CI, 3.4-3.8) for waking frequently and 2.8 (95% CI 2.6-3.0) for early-morning awakening. For nonusers, meanwhile, the mean ratings were 2.3 (95% CI, 2.2-2.5), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.

“None of the 1-year changes were statistically significant, nor were they different between medication users and non-users,” the authors write. “Two year follow-up results were consistent, without statistically significant reductions in sleep disturbance in medication users compared with non-users.”

Researchers suggest that the effectiveness of long-term sleep medication use should be re-examined.

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