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Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00156533
First received: September 7, 2005
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Insomnia
Primary Insomnia
Psychophysiologic Insomnia
 Drug: Zolpidem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Sleep Latency (SL) [ Time Frame: Baseline and Post-treatment (12wks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Wake After Sleep Onset (WASO) [ Time Frame: Baseline and Post-Treatment (12 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
QHS dosing with placebo (i.e. nightly dose)
Active Comparator: QHS Zolpidem
QHS dosing with 10mg of zolpidem (i.e. nightly dose)
 Drug: Zolpidem
10 mg of Zolpidem
Other Name: Ambien
Experimental: Intermittant Zolpidem
Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
 Drug: Zolpidem
10 mg of Zolpidem
Other Name: Ambien
No Intervention: Control
Monitor only condition (no placebo, no drug).

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.
  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156533

Locations
United States, New York
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Sanofi-Synthelabo
Investigators
Principal Investigator: Michael L Perlis, Ph.D. University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00156533     History of Changes
Other Study ID Numbers: PI Initiated, 11045
Study First Received: September 7, 2005
Results First Received: October 10, 2011
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Insomnia
Sleep
zolpidem
Ambien
Hypnotics

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013