Over Time, Prescription Sleep Medicines for Middle-Aged Women Have Little Benefit

Long-term use of prescription sleep medications provided no benefit in a study of middle-aged women, suggesting the use of these drugs should be reevaluated.

Researchers compared 238 women who started sleep medications with 447 nonusers whose sleep disturbance ratings were similar at the outset. The study, published in BMJ Open, then compared them at the 1- and 2-year marks.

At the outset, both groups of women reported difficulty falling asleep 1 out of every 3 nights, waking frequently on 2 out of 3 nights, and waking up early 1 in every 3 nights of the week. More than 70% of women in both groups reported disturbed sleep at least 3 times a week. No significant changes occurred at the 1- and 2-year milestones.

Sleep disturbance is common in the United States, with 9 million Americans reporting usage of medications. Poor quality sleep is associated with many chronic conditions, including diabetes, high blood pressure, pain and depression, and various drugs are prescribed to help patients.

They include benzodiazepines, Z-drugs (selective BZD receptor agonists that include zolpidem, zaleplon, and eszopiclone), and other medications used off label and mostly intended for conditions such as anxiety and depression.

Clinical trial data indicate many of these drugs work in the short term (up to 6 months), but insomnia can be chronic, and many take these drugs for longer, according to the researchers. Data was used from the Study of Women’s Health Across the Nation, a long-term multicenter study in the United States looking at biological and psychosocial changes arising during menopause. The participants were 49.9 years old on average. The group was ethnically diverse, with half of participants White.

The mean scores for difficulty falling asleep, waking frequently, and early-morning awakening were similar for both groups throughout the study. None of the 1-year changes were statistically significant for either group, and there were no significant differences between users and nonusers. The results at the 2-year mark were similar. Scores were based on a 5-point Likert scale, with 1 representing no difficulty and 5 representing difficulty 5-7 nights per week.

The score for difficulty initiating sleep for medication users was 2.7 (95% CI, 2.5-2.9) at the outset and 2.6 (95% CI, 2.4-2.8) at the 1-year mark. For nonusers, the scores were 2.6 (95% CI, 2.5-2.7) at the outset and 2.3 (95% CI, 2.2 -2.5) at the 1-year mark.

For waking frequently, scores for medication users were 3.8 (95% CI, 3.6-3.9) at the outset and 3.6 (95% CI, 3.4-3.8) at the 1-year mark. For nonusers, the scores were 3.7 (95% CI, 3.6-3.9) at the outset and 3.5 (95% CI, 3.3-3.6) at the 1-year mark.

For early-morning awakening, scores for medication users were 2.8 (95% CI, 2.6-3.0) at both the outset and the 1-year mark. For nonusers, scores were 2.8 (95% CI, 2.6-3.0) and 2.5 (95% CI, 2.3-2.6) at the 1-year mark.

Reference

Solomon DH, Ruppert K, Habel LA, et al. Prescription medications for sleep disturbances among midlife women during 2 years of follow-up: A SWAN retrospective cohort study. BMJ Open. 2021;11:e045074. doi:10.1136/bmjopen-2020-045074