Zolpidem and behavior therapy significantly reduce daytime symptoms of insomnia such as fatigue, functional impairments, and depressive symptoms, data suggested.
In a randomized clinical trial of more than 200 patients with chronic insomnia, behavioral therapy was associated with a 4.7-point reduction in Multidimensional Fatigue Inventory (MFI) score. Zolpidem was associated with a 5.2-point reduction in this score.
“There may be some advantage to starting with behavioral intervention,” study author Charles Morin, PhD, Canada research chair in sleeping disorders at Laval University in Quebec City, told this news organization. “But by the same token, because it takes a bit more time to produce benefits, some patients quit too quickly. So, even if we want to minimize the use of medications because of potential side effects, there may be times where we need to use it.”
The results were published in JAMA Network Open.
‘Different Treatment Options’
There is growing awareness that sleep is a critical pillar of good health that is just as important as good nutrition and exercise, said Dr. Morin. Clinicians thus need to pay more attention to the toll of poor sleep on physical and mental health, he added.
For the current study, the investigators randomly assigned 211 adults with chronic insomnia to behavioral therapy, which included sleep restriction and stimulus control procedures, or zolpidem (5-10 mg nightly) for 6 weeks. Participants who achieved insomnia remission by that point were followed for 12 months. Participants who did not achieve remission were randomly assigned to a second-stage psychological therapy or medication therapy (zolpidem or trazodone).
The outcome measures were daytime functional outcomes such as mood disturbances, fatigue, functional impairments of insomnia, and physical and mental health. The researchers assessed these outcomes at baseline, 6 weeks, the end of second-stage therapy, and 3- and 12-month follow-up visits.
Both initial treatments were associated with significant and equivalent reductions in depressive symptoms, fatigue, and functional impairments. Mean change in the Beck Depression Inventory-II was −3.5 for patients in the behavioral therapy arm and −4.3 for patients in the zolpidem arm. Mean change in the MFI score was −4.7 among patients who received behavioral therapy and −5.2 among those who received zolpidem. Mean change in the Work and Social Adjustment Scale, which measured functional impairments, was −5.0 for the behavioral therapy arm and −5.1 for the zolpidem arm.
In addition, both treatments were associated with improvements in mental health, as measured by the Short-Form Health Survey (SF-36). Mean change in the mental health subscale of SF-36 was 3.5 points in the behavioral therapy arm and 2.5 points in the zolpidem arm.
Second-stage treatments were associated with further improvements, and these benefits were maintained throughout the 12 months of follow-up. These findings support adding a second treatment of insomnia as part of efforts to address daytime function, the authors wrote.
“If the first treatment doesn’t work, we should not stop there. There are different treatment options,” said Dr. Morin.
“Future developments of insomnia treatment strategies should take into account the daytime consequences of insomnia,” wrote the investigators. “Additional studies are needed to further investigate the potential benefits of switching treatment modalities and incorporating a therapeutic component that can address psychological and mood disturbances.”
The authors acknowledged that the study was limited by the lack of a control condition and by relatively small sample sizes for each treatment group, which may reduce the statistical power to detect more significant group differences. They also noted that only patients who did not achieve insomnia remission received second-stage therapy, but those who did achieve remission can still have residual daytime impairments (eg, fatigue and mood disturbances) that are associated with future relapse.