SleepPhase 4NCT01159652
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
A Phase 4 study testing zaleplon and zolpidem extended release in people with Sleep and Memory, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- zaleplon and zolpidem extended release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2011
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age
- no sleep complaints or problems
- good sleep quality per questionnaire
- sufficient time in bed each night
Who cannot join
- any clinically significant unstable medical condition
- recent psychiatric disorder
- prior diagnosis or symptoms of a sleep disorder
- recent history of substance abuse
- recent use of prescription hypnotic medication or over-the-counter sleep aid
- recent use of psychotropic medication
Show all 13Show fewer
- history of adverse reaction to benzodiazepines
- body mass index > 36
- currently pregnant or nursing
- currently working rotating or night shift
- consumption of > 700 mg per day of xanthine-containing food or beverages
- consumption of > 14 units of alcohol per week
- smoke > 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Hospital Sleep Medicine and Research Center
Chesterfield, Missouri, 63017
About this study
Official title: Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night
The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.
Read the detailed description
A growing body of evidence has demonstrated that sleep promotes memory consolidation in healthy individuals. However, little research has been conducted regarding the effect of hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers. Another study reported significant impairment of sleep-dependent memory on a motor task with triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation, but further investigation is clearly needed in this area. Because hypnotics are commonly prescribed for insomnia, it is important to determine if there is a significant risk of impairment in sleep-dependent memory consolidation associated with these medications. Further, investigation of alternative doses and drug regimens upon memory consolidation appears warranted.
The purpose of the current study is to determine the effect of two hypnotic medications on sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which will be active for most of the sleep period when administered at bedtime, will be compared to zaleplon, which will be active for half of the sleep period when administered in the middle of the night. This comparison allows us to address the question of whether a few hours of drug-free sleep results in better memory consolidation than sleep with drug throughout the night.
- Being tested
- zaleplon, zolpidem extended release, bedtime placebo, middle of the night placebo
- Keywords
- sleep, memory, hypnotics, zaleplon, zolpidem, Sonata, Ambien, Hypnotics and Sedatives, Polysomnography, Monitoring, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zaleplonDrug
Also called Sonata
10 mg
zolpidem extended releaseDrug
Also called Ambien CR
12.5 mg
bedtime placeboDrug
placebo
middle of the night placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Bedtime Placebo | Placebo comparator | Not described Receives: Drug: bedtime placebo |
| Middle of the Night Placebo | Placebo comparator | Not described Receives: Drug: middle of the night placebo |
| Zolpidem | Experimental | Not described Receives: Drug: zolpidem extended release |
| Zaleplon | Experimental | Not described Receives: Drug: zaleplon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Two memory tasks will be used to assess memory.
Measured: 8 timepoints: 4 evenings and 4 mornings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Janine M Hall-Porter, PhD, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159652
- Sponsor's protocol ID
- 63-SR-10
- Status last verified
- Aug 2014
- First submitted
- 8 Jul 2010
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Greenblatt DJ, Harmatz JS, von Moltke LL, Ehrenberg BL, Harrel L, Corbett K, Counihan M, Graf JA, Darwish M, Mertzanis P, Martin PT, Cevallos WH, Shader RI. Comparative kinetics and dynamics of zaleplon, zolpidem, and placebo. Clin Pharmacol Ther. 1998 Nov;64(5):553-61. doi: 10.1016/S0009-9236(98)90139-4.
PubMed 9834048Weinling E, McDougall S, Andre F, Bianchetti G, Dubruc C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol. 2006 Aug;20(4):397-403. doi: 10.1111/j.1472-8206.2006.00415.x.
PubMed 16867025
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night
- ClinicalTrials.gov ID
- NCT01159652
- Acronym / sponsor ID
- 63-SR-10
- Keywords
- sleep, memory, hypnotics, zaleplon, zolpidem, Sonata, Ambien, Hypnotics and Sedatives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jul 2010 (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 this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.
Detailed description
A growing body of evidence has demonstrated that sleep promotes memory consolidation in healthy individuals. However, little research has been conducted regarding the effect of hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers. Another study reported significant impairment of sleep-dependent memory on a motor task with triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation, but further investigation is clearly needed in this area. Because hypnotics are commonly prescribed for insomnia, it is important to determine if there is a significant risk of impairment in sleep-dependent memory consolidation associated with these medications. Further, investigation of alternative doses and drug regimens upon memory consolidation appears warranted.
The purpose of the current study is to determine the effect of two hypnotic medications on sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which will be active for most of the sleep period when administered at bedtime, will be compared to zaleplon, which will be active for half of the sleep period when administered in the middle of the night. This comparison allows us to address the question of whether a few hours of drug-free sleep results in better memory consolidation than sleep with drug throughout the night.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bedtime Placebo | Placebo comparator | Drug: bedtime placebo |
| Middle of the Night Placebo | Placebo comparator | Drug: middle of the night placebo |
| Zolpidem | Experimental | Drug: zolpidem extended release |
| Zaleplon | Experimental | Drug: zaleplon |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 50 years of age
- no sleep complaints or problems
- good sleep quality per questionnaire
- sufficient time in bed each night
Key exclusion criteria (13 listed)
- any clinically significant unstable medical condition
- recent psychiatric disorder
- prior diagnosis or symptoms of a sleep disorder
- recent history of substance abuse
- recent use of prescription hypnotic medication or over-the-counter sleep aid
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 |
|---|---|---|
| zaleplonAlso: Sonata10 mg | Drug | Zaleplon |
| zolpidem extended releaseAlso: Ambien CR12.5 mg | Drug | Zolpidem |
| bedtime placeboplacebo | Drug | Bedtime Placebo |
| middle of the night placeboplacebo | Drug | Middle of the Night Placebo |
Primary outcome
Memory
Time frame: 8 timepoints: 4 evenings and 4 mornings
Two memory tasks will be used to assess memory.
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 26 Aug 2014.
- Background: PubMed 9834048Greenblatt DJ, Harmatz JS, von Moltke LL, Ehrenberg BL, Harrel L, Corbett K, Counihan M, Graf JA, Darwish M, Mertzanis P, Martin PT, Cevallos WH, Shader RI. Comparative kinetics and dynamics of zaleplon, zolpidem, and placebo. Clin Pharmacol Ther. 1998 Nov;64(5):553-61. doi: 10.1016/S0009-9236(98)90139-4.
- Background: PubMed 16867025Weinling E, McDougall S, Andre F, Bianchetti G, Dubruc C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol. 2006 Aug;20(4):397-403. doi: 10.1111/j.1472-8206.2006.00415.x.
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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.
Janine M Hall-Porter, PhD principal investigator
St. Luke's Hospital
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 zaleplon and zolpidem extended release in people with Sleep and Memory, run by St. Luke's Hospital, Chesterfield, Missouri 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 13 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 26 Aug 2014. 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?
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?
Memory (time frame: 8 timepoints: 4 evenings and 4 mornings). 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 NCT01159652, which also lists 2 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 26 Aug 2014.