Durham, North Carolina 27710

  • Sleep Initiation and Maintenance Disorders


This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Study summary:

Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia. During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires. Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires. After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study. After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.


Inclusion Criteria: - be between 21 and 75 years of age - have a mean total nocturnal wake time of > 60 min./night - have a history of insomnia > 6 months - have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by > 2 hrs. from day to day, or routinely lying in bed awake for periods > 30 min Exclusion Criteria: - pregnant women - the terminally ill - individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep - individuals with major psychiatric diagnoses - persons with hypnotic-dependent insomnia - subjects on antidepressants or anxiolytics - subjects with evidence of sleep apnea



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Durham, North Carolina 27710
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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