Primary InsomniaNCT01006525
Safety and Efficacy of Chronic Hypnotic Use
An observational study of Primary Insomnia, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- zolpidem
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary insomniacs meeting DSM-IV criteria, ages 23-70 yrs. old, were recruited from public advisement for a double-blind placebo controlled study. Participants were in good general health as determined by a physical exam and laboratory tests. The Structured Clinical Interview for DSM Disorders (SCID) and the Hamilton Depression Scale were used to exclude those with psychiatric disorders, drug, and alcohol dependence. To confirm the absence of illicit drugs, participants underwent a urine drug screen. Additionally, participants had a screening sleep efficiency of <85% on an 8-hr nocturnal polysomnogram (NPSG) and had no primary sleep disorders. Pregnant or lactating females were excluded from study participation.
Who may be able to join
- age 21-70 yrs
- non-pregnant females who agree to standard birth control for 12 months and males
- two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.
- meet DSM-IV criteria for primary insomnia
Who cannot join
- any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.
- chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.
- current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.
- a history of alcohol or substance abuse within the past two years.
- a prestudy positive urine drug screen
- consuming >14 standard (1oz) alcoholic drinks per week
Show all 10Show fewer
- caffeine consumption >300 mg/day
- smoking during the night (11pm-7am).
- medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented.
- sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Sleep and Research Center
Detroit, Michigan, 48202
About this study
Official title: Abuse Liability Associated With Chronic Hypnotic Use
The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.
Read the detailed description
The acknowledged drugs of choice for the pharmacological treatment of insomnia are the benzodiazepine receptor agonist hypnotics (BzRA). Studies show that at therapeutic doses, used over the short-term, the abuse liability of BzRAs is relatively low and their efficacy outweighs their minimal risks. However, an increasing number of patients use BzRAs nightly for longer periods of time than is currently indicated (i.e. 4 weeks) and, minimal data on the long-term abuse liability and efficacy of these drugs exist.
This project, using both prospective and retrospective methods, will address questions about the long-term abuse liability and efficacy of the BzRAs. The questions being raised are: What are the abuse liability and efficacy of hypnotics currently being used chronically and what is the prospective abuse liability and efficacy of hypnotics used chronically? Zolpidem is the chosen standard for this project as it is the most frequently prescribed BzRA and also arguably the BzRA with the best short-term efficacy and safety profile. The focus of the first question is clinical; it is about the long-term abuse liability and efficacy of BzRAs, specifically zolpidem, as it is currently being prescribed and about the type of patients who receive this drug. The second question addresses the issue of whether a standard BzRA can be prescribed efficaciously and safely for the long-term to patients with primary insomnia.
- Conditions
- Primary Insomnia
- Being tested
- zolpidem
- 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 zolpidem (Ambien)
placebo or zolpidem (10mg)daily for one year
| Study group | Role | What they receive |
|---|---|---|
| Insomniacs | Primary insomniacs, ages 21-70, in good general health. Receives: Drug: zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep recording measures
Measured: one year
Secondary outcomes (1)
Urine and saliva cortical levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startDec 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Investigators
- Timothy A. Roehrs, Ph.D., Principal investigator, Henry Ford Health SystemSurilla Randall, Ph.D., Study director, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006525
- Sponsor's protocol ID
- R01DA017355
- Status last verified
- Nov 2011
- First submitted
- 2 Nov 2009
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to rebound insomnia or withdrawal symptoms: a prospective placebo-controlled study. J Psychopharmacol. 2012 Aug;26(8):1088-95. doi: 10.1177/0269881111424455. Epub 2011 Oct 16.
PubMed 22004689Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. Sleep. 2011 Feb 1;34(2):207-12. doi: 10.1093/sleep/34.2.207.
PubMed 21286241Roehrs T, Roth T. Hyperarousal in insomnia: pre-sleep and diurnal cortisol levels in response to chronic zolpidem treatment. Sleep Med. 2019 Sep;61:52-56. doi: 10.1016/j.sleep.2019.04.010. Epub 2019 Apr 25.
PubMed 31255482Roehrs TA, Roth T. Hyperarousal in insomnia and hypnotic dose escalation. Sleep Med. 2016 Jul;23:16-20. doi: 10.1016/j.sleep.2016.06.008. Epub 2016 Jul 6.
PubMed 27692272Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016 Mar;12(3):319-25. doi: 10.5664/jcsm.5574.
PubMed 26446253Randall S, Roehrs TA, Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.
PubMed 23115404
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abuse Liability Associated With Chronic Hypnotic Use
- ClinicalTrials.gov ID
- NCT01006525
- Acronym / sponsor ID
- R01DA017355
- Conditions
- Primary Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.
Detailed description
The acknowledged drugs of choice for the pharmacological treatment of insomnia are the benzodiazepine receptor agonist hypnotics (BzRA). Studies show that at therapeutic doses, used over the short-term, the abuse liability of BzRAs is relatively low and their efficacy outweighs their minimal risks. However, an increasing number of patients use BzRAs nightly for longer periods of time than is currently indicated (i.e. 4 weeks) and, minimal data on the long-term abuse liability and efficacy of these drugs exist.
This project, using both prospective and retrospective methods, will address questions about the long-term abuse liability and efficacy of the BzRAs. The questions being raised are: What are the abuse liability and efficacy of hypnotics currently being used chronically and what is the prospective abuse liability and efficacy of hypnotics used chronically? Zolpidem is the chosen standard for this project as it is the most frequently prescribed BzRA and also arguably the BzRA with the best short-term efficacy and safety profile. The focus of the first question is clinical; it is about the long-term abuse liability and efficacy of BzRAs, specifically zolpidem, as it is currently being prescribed and about the type of patients who receive this drug. The second question addresses the issue of whether a standard BzRA can be prescribed efficaciously and safely for the long-term to patients with primary insomnia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insomniacs | – | Drug: zolpidemPrimary insomniacs, ages 21-70, in good general health. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary insomniacs meeting DSM-IV criteria, ages 23-70 yrs. old, were recruited from public advisement for a double-blind placebo controlled study. Participants were in good general health as determined by a physical exam and laboratory tests. The Structured Clinical Interview for DSM Disorders (SCID) and the Hamilton Depression Scale were used to exclude those with psychiatric disorders, drug, and alcohol dependence. To confirm the absence of illicit drugs, participants underwent a urine drug screen. Additionally, participants had a screening sleep efficiency of <85% on an 8-hr nocturnal polysomnogram (NPSG) and had no primary sleep disorders. Pregnant or lactating females were excluded from study participation.
Key inclusion criteria (4 listed)
- age 21-70 yrs
- non-pregnant females who agree to standard birth control for 12 months and males
- two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.
- meet DSM-IV criteria for primary insomnia
Key exclusion criteria (10 listed)
- any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.
- chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.
- current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.
- a history of alcohol or substance abuse within the past two years.
- a prestudy positive urine drug screen
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: zolpidem (Ambien)placebo or zolpidem (10mg)daily for one year | Drug | Insomniacs |
Primary outcome
Sleep recording measures
Time frame: one year
1 secondary outcome
Urine and saliva cortical levels
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Results publication: PubMed 22004689Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to rebound insomnia or withdrawal symptoms: a prospective placebo-controlled study. J Psychopharmacol. 2012 Aug;26(8):1088-95. doi: 10.1177/0269881111424455. Epub 2011 Oct 16.
- Results publication: PubMed 21286241Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. Sleep. 2011 Feb 1;34(2):207-12. doi: 10.1093/sleep/34.2.207.
- Derived from this study: PubMed 31255482Roehrs T, Roth T. Hyperarousal in insomnia: pre-sleep and diurnal cortisol levels in response to chronic zolpidem treatment. Sleep Med. 2019 Sep;61:52-56. doi: 10.1016/j.sleep.2019.04.010. Epub 2019 Apr 25.
- Derived from this study: PubMed 27692272Roehrs TA, Roth T. Hyperarousal in insomnia and hypnotic dose escalation. Sleep Med. 2016 Jul;23:16-20. doi: 10.1016/j.sleep.2016.06.008. Epub 2016 Jul 6.
- Derived from this study: PubMed 26446253Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016 Mar;12(3):319-25. doi: 10.5664/jcsm.5574.
- Derived from this study: PubMed 23115404Randall S, Roehrs TA, Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.
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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.
Timothy A. Roehrs, Ph.D. principal investigator
Henry Ford Health System
Surilla Randall, Ph.D. study director
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Insomnia, run by Henry Ford Health System 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 10 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 7 Nov 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 recording measures (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01006525, which also lists 6 linked publications.
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 7 Nov 2011.