June 14, 2007 (Minneapolis) — The use of combined therapy that targets both insomnia and generalized anxiety disorder (GAD) significantly improves sleep and daytime functioning, compared with monotherapy, results of a new study suggest. The results were presented at SLEEP 2007, the 21st Annual Meeting of the Associated Professional Sleep Societies.
According to lead author W. Vaughn McCall, MD, professor and chair of psychiatry and behavioral medicine, Wake Forest University Health Sciences, in Winston-Salem, North Carolina, the most important finding of this study is perhaps the superior efficacy of the combined therapy on daytime functioning.
"Giving someone a sleeping pill is fairly intuitive," he told Medscape. "But I think more to the point is what happens during the daytime. To see improvement in alertness and concentration and so forth is not necessarily intuitive, because there is a concern that sedatives have a hangover effect and leave a person worse off.
"I think this is a derivation of the recognition that insomnia is a 24-hour-a-day problem, not just a night-time problem anymore," he added. "So I think it is critically important to show that our insomnia treatments improve daily function."
In the study, McCall and colleagues randomized 595 patients with GAD and insomnia to combined eszopiclone (ESZ) (3 mg) and escitalopram (EO) (n = 294) or EO alone (n = 301) for 8 weeks. All patients received open-label EO (10 mg) for 10 weeks before randomization. After 8 weeks of randomized treatment, ESZ was replaced with placebo for the final 2 weeks to evaluate discontinuation effects.
Patients self-reported measures of sleep symptoms in a daily sleep diary, recording sleep latency, wake time after sleep onset, total sleep time, sleep quality, and daytime functioning symptoms. To assess patients' perceptions of their insomnia at weeks 1, 4, 8, and 10, the Insomnia Severity Index was used.
During the 8 weeks, patients treated with combined therapy reported significantly better sleep outcomes than those treated with monotherapy, as measured by sleep latency (P < .0005), wake time after sleep onset (P < .007), and total sleep time (P < .0001). More patients treated with combined therapy had no meaningful insomnia than those treated with monotherapy, based on an Insomnia Severity Index score of 7 or less (47% vs 33%; P < .001).
Notably, patients treated with combined therapy also had significant improvements in daytime functioning, including increased daytime alertness, ability to concentrate, physical well-being, and ability to function (P < .007), compared with those treated with monotherapy.
Addressing Comorbidity
Commenting on these results, Michael Bonnet, PhD, professor of neurology at Wright State University School of Medicine and director of a sleep laboratory at Dayton Veterans Affairs Medical Center, in Ohio, told Medscape that the underlying idea of this study is the increased recognition of the need to address both insomnia and the medical condition accompanying it. "What we've found with insomnia and other medical conditions," he said, "is that patients improve more rapidly when you treat both the medical condition and insomnia at the same time."
He also mentioned that this group did a similar study a year before on depression and insomnia that he found quite "startling."
According to Dr. McCall, that study showed similar efficacy with combined therapy for patients with depression and insomnia, but unlike the current study, when the patients were taken off ESZ during the 2-week run-out period, the drug benefit was maintained and the depression did not return.
In the current study, said Dr. McCall, all gains from ESZ were lost after the 2-week run-out period. "There was no rebound effect," he said, "but the gains were lost. The advantage was lost."
Asked why the results of this run-out period differed from the previous depression study, Dr. McCall speculated that GAD is more closely related to primary insomnia, so that if you remove the treatment, it is more likely that the disease will show itself again.
Support for this study was provided by Sepracor Inc. Dr. McCall reports he is an advisory board member, has received research support, and is a member of the speaker's bureau for Sepracor.
Sleep 2007: the 21st Annual Meeting of the Associated Professional Sleep Societies (APSS): Abstract 0966. Presented June 12, 2007.
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