Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00156533
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : May 16, 2013
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Wilfred Pigeon, PhD, University of Rochester

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE October 10, 2011
Results First Posted Date  ICMJE May 16, 2013
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE March 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Sleep Latency (SL) [ Time Frame: Baseline and Post-treatment (12wks) ]
Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Bi-weekly measures during 12 week follow-up for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.
  • Bi-weekly measures during baseline and treatment for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.
Change History Complete list of historical versions of study NCT00156533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Wake After Sleep Onset (WASO) [ Time Frame: Baseline and Post-Treatment (12 weeks) ]
Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • weekly insomnia ratings
  • weekly sleepiness/fatigue ratings
  • weekly mood ratings
  • weekly medical symptoms checklist
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
Official Title  ICMJE Long Term Treatment With Zolpidem: The Relative Efficacy of Nightly (Quaque Hora Somni [QHS]) & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.
Brief Summary We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.
Detailed Description

To date, the aggressive treatment (Tx) of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible. While what constitutes maintenance therapy is a matter of debate, there are two studies which show that benzodiazepine receptor agonists (BZRAs) 1) are effective when used intermittently for up to 3 months and 2) may be used on a nightly basis for up to 6 months with no loss of efficacy.

The significance of the present research is two fold. First, it will allow us to compare the two primary strategies used for long term treat of insomnia (nightly dosing vs intermittent dosing). Second, it will allow an evaluation of the possibility that extended treatment, given careful withdrawal from medication, may yield long term clinical gains.

Re: Objective 1: It is widely assumed that intermittent dosing confers increased efficacy. That is, less frequent medication use will extend the duration of time for which the medication is maximally potent. An empirical assessment of this proposition is required. If incorrect, physicians and patients should be encouraged to adopt a more aggressive approach to treatment. If correct, physicians and patients should be encouraged to adopt the intermittent dosing approach to treatment.

Re: Objective 2: It is widely assumed that treatment with sedatives (sleep promoting medications) constitutes only palliative care. An empirical assessment of this proposition is required. If correct, physicians and patients should be encouraged to adopt a more aggressive approach to long term treatment. If incorrect, physicians and patients should be encouraged to adopt an approach to treatment that is not currently a standard of practice: extended treatment with a clear plan to taper medication that is designed to maintain the clinical gains that occurred with medication use.

We propose to evaluate the above issues in a pilot study of 40 subjects with Primary Insomnia where subjects are randomized to one of 4 conditions:

  1. QHS dosing with placebo
  2. QHS dosing with 10mg of zolpidem
  3. Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
  4. Monitor only condition.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Primary Insomnia
  • Psychophysiologic Insomnia
Intervention  ICMJE
  • Drug: Zolpidem
    10 mg of Zolpidem
    Other Name: Ambien
  • Drug: Sugar Pill
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    QHS dosing with placebo (i.e. nightly dose)
    Intervention: Drug: Sugar Pill
  • Active Comparator: QHS Zolpidem
    QHS dosing with 10mg of zolpidem (i.e. nightly dose)
    Intervention: Drug: Zolpidem
  • Experimental: Intermittant Zolpidem
    Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
    Intervention: Drug: Zolpidem
  • No Intervention: Control
    Monitor only condition (no placebo, no drug).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2011)
20
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
44
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 25 - 55
  • a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
  • Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
  • complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria:

  • Unstable medical or psychiatric illness
  • Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
  • symptoms suggestive of sleep disorders other than insomnia
  • polysomnographic data indicating sleep disorders other than insomnia
  • Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
  • inadequate language comprehension
  • pregnancy
  • first-degree relatives with bipolar disorder or schizophrenia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00156533
Other Study ID Numbers  ICMJE PI Initiated
11045 ( Other Identifier: University of Rochester )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wilfred Pigeon, PhD, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Sanofi-Synthelabo
Investigators  ICMJE
Principal Investigator: Michael L Perlis, Ph.D. University of Rochester
PRS Account University of Rochester
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP