Overview

Combined Behavioral/Pharmacological Therapy for Insomnia

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Zolpidem
Criteria
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