InsomniaPhase 4NCT00156533
Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
A Phase 4 study testing Zolpidem and Sugar Pill in people with Insomnia and Primary Insomnia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Insomnia, Primary Insomnia, Psychophysiologic Insomnia
- What is being tested?
- Zolpidem and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Feb 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Sleep Research Laboratory
Rochester, New York, 14642
About this study
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.
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.
Read the 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:
- QHS dosing with placebo
- QHS dosing with 10mg of zolpidem
- Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
- Monitor only condition.
- Conditions
- Insomnia, Primary Insomnia, Psychophysiologic Insomnia
- Being tested
- Zolpidem, Sugar Pill
- Keywords
- Insomnia, Sleep, zolpidem, Ambien, Hypnotics
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
Also called Ambien
10 mg of Zolpidem
Sugar PillDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | QHS dosing with placebo (i.e. nightly dose) Receives: Drug: Sugar Pill |
| QHS Zolpidem | Active comparator | QHS dosing with 10mg of zolpidem (i.e. nightly dose) Receives: Drug: Zolpidem |
| Intermittant Zolpidem | Experimental | Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed Receives: Drug: Zolpidem |
| Control | No intervention | Monitor only condition (no placebo, no drug). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Latency (SL)
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.
Measured: Baseline and Post-treatment (12wks)
Secondary outcomes (1)
Wake After Sleep Onset (WASO)
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.
Measured: Baseline and Post-Treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Principal investigator, Wilfred Pigeon, PhD, University of Rochester
- Investigators
- Michael L Perlis, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156533
- Sponsor's protocol ID
- PI Initiated
- Other IDs
- 11045
- Status last verified
- Oct 2015
- First submitted
- 7 Sep 2005
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00156533
- Acronym / sponsor ID
- PI Initiated
- Conditions
- Insomnia, Primary Insomnia, Psychophysiologic Insomnia
- Keywords
- Insomnia, Sleep, zolpidem, Ambien, Hypnotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Mar 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- QHS dosing with placebo
- QHS dosing with 10mg of zolpidem
- Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
- Monitor only condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sugar PillQHS dosing with placebo (i.e. nightly dose) |
| QHS Zolpidem | Active comparator | Drug: ZolpidemQHS dosing with 10mg of zolpidem (i.e. nightly dose) |
| Intermittant Zolpidem | Experimental | Drug: ZolpidemIntermittent dosing with 10mg of zolpidem (3-5 pills per week as needed |
| Control | No intervention | –Monitor only condition (no placebo, no drug). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemAlso: Ambien10 mg of Zolpidem | Drug | Intermittant Zolpidem, QHS Zolpidem |
| Sugar Pill | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Wake After Sleep Onset (WASO)
Time frame: Baseline and Post-Treatment (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Perlis, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem and Sugar Pill in people with Insomnia and Primary Insomnia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Latency (SL) (time frame: Baseline and Post-treatment (12wks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.