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Does the addition of zolpidem to cognitive behavioural therapy (CBT) improve persistent insomnia compared with CBT alone?
160 adults (97 female; >30 years old) with chronic insomnia (DSM-IV and International Classification of Sleep Disorders).
University Hospital Sleep Centre, Quebec, Canada; January 2002-April 2005.
Acute phase (6 weeks’ duration): CBT versus CBT plus zolpidem (10 mg/night). CBT involved one 90 min group session per week. Extended phase (6 months’ duration): The CBT alone group was randomised to either extended CBT (one individually tailored session per month) or no further treatment; the CBT plus zolpidem group was randomised to either CBT alone or CBT plus zolpidem as needed.
Primary outcomes: Sleep onset latency, time awake post sleep onset, total sleep time and sleep efficiency (total sleep time: time spent in bed) derived from self-report sleep diaries. Secondary outcomes: the four sleep indices used as primary outcomes derived from laboratory sleep evaluations (polysomnography); response (defined as change from baseline >7 in the patient reported Insomnia Severity Index (ISI) total score) and remission (ISI score <8).
93.1% completed the acute phase, 88.1% completed …
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