Study in middle-aged women 'does not support' long-term use of sleep medications
Middle-aged women enrolled in a large retrospective cohort study reported similar rates of sleep disturbances after 1 and 2 years of starting sleep medications, according to findings published in BMJ Open.
The results of the study indicate that “the effectiveness of long-term sleep medication use should be re-examined,” according to the researchers.
“While sleep medications are recommended for short courses, sleep disturbances may be chronic and many patients use these agents for long periods, sometimes intermittently and other times nightly,” Daniel H. Solomon, MD, MPH, and colleagues wrote. “Thus, data from typical practice would be useful for patients and clinicians if it included sleep medications used over several months in populations of patients with sleep disturbances; we found no such studies in the literature.”
Solomon — chief of the section of clinical sciences at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School — and colleagues examined the impact of prescription sleep medications on patient-reported sleep disturbances among a group of “racially and ethnically diverse middle-aged women,” according to the study results. The researchers specifically looked at trouble commencing sleep, repeated waking and early morning awakening during the preceding 2 weeks. They examined these differences with a five-point Likert scale that ranged from no difficulty with sleep on any night (rating of 1) to difficulty with sleep on five or more nights (rating of 5) and compared sleep disturbances at 1 year and at 2 years of follow-up. Sleep disturbances at 1 year served as the study’s primary outcome.
The researchers enrolled women who, at baseline, self-reported sleep disturbances but did not report “prevalent” use of sleep medications. They matched women who later began using sleep medications on a propensity score with women who did not and followed them all for 1 to 2 years, conducting annual evaluations of sleep disturbances.
The analysis included 238 women who began using sleep medications and 447 women who did not, according to the study results. More than half of the women in the study were white (57.5%); the study also included Black (23.1%), Japanese (9.2%), Chinese (6.6%) and Hispanic (3.7%) women. The mean age of participants was 49.5 years.
Solomon and colleagues found that sleep disturbance ratings at baseline were similar across both groups. Medication users had a mean score of 2.7 for difficulty initiating sleep (95% CI, 2.5-2.9), 3.8 for waking often (95% CI, 3.6-3.9) and 2.8 for early morning waking (95% CI 2.6-3). Ratings among women who did not use sleep medications were 2.6 for difficulty initiating sleep (95% CI, 2.5-2.7), 3.7 for waking often (95% CI, 3.6-3.9) and 2.7 for early morning waking (95% CI, 2.6-2.8).
Additionally, the researchers found no statistical significance in the changes reported at 1 year and no differences between women using medication and women who were not. They also reported “consistent” follow-up results at 2 years, with no statistically significant decreases in sleep disturbances among women using medication compared with women who were not.
Most data regarding the efficacy of sleep medications are derived from short-term studies in the range of 2 to 12 weeks, despite that these agents “appear to be used over the long-term by many patients,” according to Solomon and colleagues.
“While there are good data from [randomized controlled trials] that these medications improve sleep disturbances in the short term, the results we present here represent some of the only data on these medications’ long-term impact on sleep,” the researchers wrote. “The lack of benefit observed in the current study suggests that when physicians begin prescribing these medicines, they should discuss with patients that many patients continue them long-term, and that there is scant evidence demonstrating benefit to using these medicines beyond several months.”
The current results also raise a “broader issue” for clinicians to consider in prescribing these medications “when their expected use differs substantially from the [randomized controlled trial] evidence,” Solomon and colleagues noted.
“Without evidence from [randomized controlled trials] demonstrating the benefit of a given type of drug in a given patient population using the drug for a similar duration, clinicians lack the necessary information to prescribe appropriately,” the researchers wrote. “Real-world data, or data from observational cohorts such as what we present here, provide important opportunities for looking at the way drugs may actually be used in typical practice.”
The researchers acknowledged several limitations of the present study, including the use of self-reported sleep disturbances, the lack of randomization regarding sleep medication use and no data regarding daytime consequences of sleep disturbances, among others. However, they also described the study’s strengths, including the inclusion of a cohort of women “during a high-risk period for sleep disturbance.”
“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with non-users,” Solomon and colleagues wrote. “While some small percentage of patients with sleep disturbances may receive benefit from using these medications over several years, the lack of benefit associated with use of sleep medications in the population studied after 1 and 2 years should help inform clinicians and patients considering initiating pharmacological treatment for midlife women who have sleep complaints.”