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Insomnia Medication Boosts Sleep Scores in Patients With Depression: Presented at APA

By Carole Bullock

WASHINGTON, DC -- May 13, 2008 -- Patients on antidepressive therapy for major depressive disorder (MDD) who suffer from insomnia appear to reap benefits from the use of zolpidem extended release (ER) without any added adverse effects, researchers reported here at the 161st Annual Meeting of the American Psychiatric Association (APA).

"Zolpidem extended release given nightly significantly improved multiple insomnia symptoms in patients with comorbid insomnia and major depressive disorder," said Maurizio Fava, MD, Vice Chair, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, and Professor of Psychiatry, Harvard Medical School, Boston. "At all time points, zolpidem ER significantly improved the total sleep time."

The multicenter, 2-phased, double-blind, parallel-group, placebo-controlled study enrolled adult patients with comorbid insomnia and MDD who were treated concomitantly with the antidepressant escitalopram, Dr. Fava said in a presentation on May 8.

Dr. Fava and colleagues enrolled 385 patients aged 18 to 64 years who were diagnosed with MDD and comorbid insomnia and were randomized to receive escitalopram 10 mg/day and either zolpidem ER 12.5 mg or placebo nightly for 24 weeks.

"We have in the past observed that when patients get depressed they will often have sleep disturbances, so it may be important to recognize that sleep deprivation and depression go hand in glove and should be treated accordingly," he said in an interview.

A total of 119 of 193 enrolled patients received zolpidem ER, and 67 of 96 enrolled patients receiving placebo completed the first phase of the study. Sleep variables were assessed by morning questionnaires for 8 weeks. Patients whose depression responded were treated for an additional 16 weeks in the second phase. This cohort included 125 patients in the zolpidem ER arm and 60 patients in the placebo arm.

Zolpidem ER led to significant improvements at all time points for total sleep time, wake time after sleep onset, number of awakenings, sleep quality, and sleep latency compared with placebo (P <= .0003), reported the investigators.

Similarly, statistical differences were observed between zolpidem ER and placebo in the second phase, 4-week assessments for total sleep time, wake time after sleep onset, number of awakenings, and sleep quality for each measure/time point (P < .05).

Significant improvements in morning energy and sleep impact on daily activities were observed for zolpidem ER for all time points in the first and second phases of the study versus placebo for each measure/time point (P < .05).

However, zolpidem ER did not significantly augment improvements in Hamilton Depression Rating Scale during the study, noted Dr. Fava.

Adverse effects for zolpidem versus placebo patients included headache (14.1% vs 17.9%) and nausea (10.9% vs 8.4%).

There was "no evidence of rebound insomnia upon discontinuation," the researchers noted.

Funding for this study was provided by sanofi-aventis.


[Presentation Title: Zolpidem Extended-Release, Co-Administered With Escitalopram, Improves Insomnia in Patients With Comorbid Insomnia and Major Depressive Disorder: Poster 6-088]

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