Combined Behavioral/Pharmacological Therapy for Insomnia

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University Identifier:
First received: September 3, 2002
Last updated: September 12, 2013
Last verified: September 2013
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive-Behavioral Therapy for Insomnia
Drug: zolpidem tartrate (Ambien)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Combined Behavioral/Pharmacological Therapy for Insomnia

Resource links provided by NLM:

Further study details as provided by Duke University:

Enrollment: 162
Study Start Date: September 2001
Estimated Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien)
Placebo Comparator: Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: Placebo
Active Comparator: Cognitive Behavioral Therapy alone (no drug)
Cognitive Behavioral Therapy alone (no drug)
Behavioral: Cognitive-Behavioral Therapy for Insomnia

Detailed Description:

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.


Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044629

United States, North Carolina
Duke Sleep Disorders Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
  More Information

No publications provided

Responsible Party: Duke University Identifier: NCT00044629     History of Changes
Other Study ID Numbers: Pro00011850  R01MH062119  DSIR 83-ATAS 
Study First Received: September 3, 2002
Last Updated: September 12, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
Sleep Deprivation
Sleep Disorders

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016