Two-Drug Regimen Eases Anxiety and Insomnia

MINNEAPOLIS – Treatment with both eszopiclone and escitalopram significantly improved the symptoms of insomnia and anxiety–compared with escitalopram alone, according to data from 595 adults presented at the annual meeting of the Associated Professional Sleep Societies.

Results from a pair of studies supported by Sepracor Inc. showed that the eszopiclone/escitalopram combination was well tolerated and significantly improved not only anxiety but also the length and quality of sleep. Because insomnia often coexists with generalized anxiety disorder, a double-duty treatment regimen would be helpful for patients who suffer from both conditions, the researchers noted.

All study participants met criteria for generalized anxiety disorder and insomnia. All of them received 10 mg escitalopram (Lexapro) daily for 10 weeks. At the same time, 294 were randomized to receive 3 mg eszopiclone (Lunesta), while 301 received placebo for 8 weeks, followed by a 2-week discontinuation period.

Overall, patients who took the combination therapy showed significant improvements in mood and anxiety symptoms based on their Clinical Global Impression scale and the Hamilton Anxiety scale scores after 1, 2, 4, 6, 8, and 10 weeks of treatment, Dr. Mark H. Pollack reported. Dr. Pollack, director of the Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital, Boston, conducted the study.

Similarly, scores on the 17-item Hamilton Rating Scale for Depression (HAM-D17) were significantly better in the combination therapy group at all evaluation points. Anxiety remission rates were higher in the combination therapy group, too, compared with the placebo group (42% vs. 36%), said Dr. Pollack, who serves on the advisory boards of and has received support for research from several pharmaceutical companies, including that of Sepracor.

In a second study of the same group of patients, presented by Dr. W. Vaughn McCall, professor and chairman of the department of psychiatry and behavioral medicine at Wake Forest University, Winston-Salem, N.C., significantly more patients who received combination therapy had no clinically meaningful insomnia at 8 weeks, compared with the escitalopram-only patients (47% vs. 33%).

In addition, combination therapy patients took significantly less time to fall asleep, slept longer, and scored significantly better on the insomnia severity index than did the escitalopram-only group, said Dr. McCall, who serves on Sepracor's speakers' bureau and its advisory board.

The adverse event rates were similar in both groups during the study period (78% for the combination group and 68% for the escitalopram-only group) and were identical (16%) during the 2-week discontinuation period. Overall the treatment was well tolerated, and no patients showed evidence of rebound insomnia as a result of the medications.

The most common adverse events reported in at least 10% of the combination therapy group were unpleasant taste (24%), headache (19%), dry mouth (16%), and sleepiness (11%); the most common adverse events reported in the escitalopram-only group were headache (15%) and nausea (15%).

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MINNEAPOLIS – Treatment with both eszopiclone and escitalopram significantly improved the symptoms of insomnia and anxiety–compared with escitalopram alone, according to data from 595 adults presented at the annual meeting of the Associated Professional Sleep Societies.

Results from a pair of studies supported by Sepracor Inc. showed that the eszopiclone/escitalopram combination was well tolerated and significantly improved not only anxiety but also the length and quality of sleep. Because insomnia often coexists with generalized anxiety disorder, a double-duty treatment regimen would be helpful for patients who suffer from both conditions, the researchers noted.

All study participants met criteria for generalized anxiety disorder and insomnia. All of them received 10 mg escitalopram (Lexapro) daily for 10 weeks. At the same time, 294 were randomized to receive 3 mg eszopiclone (Lunesta), while 301 received placebo for 8 weeks, followed by a 2-week discontinuation period.

Overall, patients who took the combination therapy showed significant improvements in mood and anxiety symptoms based on their Clinical Global Impression scale and the Hamilton Anxiety scale scores after 1, 2, 4, 6, 8, and 10 weeks of treatment, Dr. Mark H. Pollack reported. Dr. Pollack, director of the Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital, Boston, conducted the study.

Similarly, scores on the 17-item Hamilton Rating Scale for Depression (HAM-D17) were significantly better in the combination therapy group at all evaluation points. Anxiety remission rates were higher in the combination therapy group, too, compared with the placebo group (42% vs. 36%), said Dr. Pollack, who serves on the advisory boards of and has received support for research from several pharmaceutical companies, including that of Sepracor.

In a second study of the same group of patients, presented by Dr. W. Vaughn McCall, professor and chairman of the department of psychiatry and behavioral medicine at Wake Forest University, Winston-Salem, N.C., significantly more patients who received combination therapy had no clinically meaningful insomnia at 8 weeks, compared with the escitalopram-only patients (47% vs. 33%).

In addition, combination therapy patients took significantly less time to fall asleep, slept longer, and scored significantly better on the insomnia severity index than did the escitalopram-only group, said Dr. McCall, who serves on Sepracor's speakers' bureau and its advisory board.

The adverse event rates were similar in both groups during the study period (78% for the combination group and 68% for the escitalopram-only group) and were identical (16%) during the 2-week discontinuation period. Overall the treatment was well tolerated, and no patients showed evidence of rebound insomnia as a result of the medications.

The most common adverse events reported in at least 10% of the combination therapy group were unpleasant taste (24%), headache (19%), dry mouth (16%), and sleepiness (11%); the most common adverse events reported in the escitalopram-only group were headache (15%) and nausea (15%).

ELSEVIER GLOBAL MEDICAL NEWS

MINNEAPOLIS – Treatment with both eszopiclone and escitalopram significantly improved the symptoms of insomnia and anxiety–compared with escitalopram alone, according to data from 595 adults presented at the annual meeting of the Associated Professional Sleep Societies.

Results from a pair of studies supported by Sepracor Inc. showed that the eszopiclone/escitalopram combination was well tolerated and significantly improved not only anxiety but also the length and quality of sleep. Because insomnia often coexists with generalized anxiety disorder, a double-duty treatment regimen would be helpful for patients who suffer from both conditions, the researchers noted.

All study participants met criteria for generalized anxiety disorder and insomnia. All of them received 10 mg escitalopram (Lexapro) daily for 10 weeks. At the same time, 294 were randomized to receive 3 mg eszopiclone (Lunesta), while 301 received placebo for 8 weeks, followed by a 2-week discontinuation period.

Overall, patients who took the combination therapy showed significant improvements in mood and anxiety symptoms based on their Clinical Global Impression scale and the Hamilton Anxiety scale scores after 1, 2, 4, 6, 8, and 10 weeks of treatment, Dr. Mark H. Pollack reported. Dr. Pollack, director of the Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital, Boston, conducted the study.

Similarly, scores on the 17-item Hamilton Rating Scale for Depression (HAM-D17) were significantly better in the combination therapy group at all evaluation points. Anxiety remission rates were higher in the combination therapy group, too, compared with the placebo group (42% vs. 36%), said Dr. Pollack, who serves on the advisory boards of and has received support for research from several pharmaceutical companies, including that of Sepracor.

In a second study of the same group of patients, presented by Dr. W. Vaughn McCall, professor and chairman of the department of psychiatry and behavioral medicine at Wake Forest University, Winston-Salem, N.C., significantly more patients who received combination therapy had no clinically meaningful insomnia at 8 weeks, compared with the escitalopram-only patients (47% vs. 33%).

In addition, combination therapy patients took significantly less time to fall asleep, slept longer, and scored significantly better on the insomnia severity index than did the escitalopram-only group, said Dr. McCall, who serves on Sepracor's speakers' bureau and its advisory board.

The adverse event rates were similar in both groups during the study period (78% for the combination group and 68% for the escitalopram-only group) and were identical (16%) during the 2-week discontinuation period. Overall the treatment was well tolerated, and no patients showed evidence of rebound insomnia as a result of the medications.

The most common adverse events reported in at least 10% of the combination therapy group were unpleasant taste (24%), headache (19%), dry mouth (16%), and sleepiness (11%); the most common adverse events reported in the escitalopram-only group were headache (15%) and nausea (15%).

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