Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
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|ClinicalTrials.gov Identifier: NCT01159652|
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : August 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep Memory||Drug: zaleplon Drug: zolpidem extended release Drug: bedtime placebo Drug: middle of the night placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
|Placebo Comparator: Bedtime Placebo||
Drug: bedtime placebo
|Placebo Comparator: Middle of the Night Placebo||
Drug: middle of the night placebo
Drug: zolpidem extended release
Other Name: Ambien CR
Other Name: Sonata
- Memory [ Time Frame: 8 timepoints: 4 evenings and 4 mornings ]Two memory tasks will be used to assess memory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159652
|United States, Missouri|
|St. Luke's Hospital Sleep Medicine and Research Center|
|Chesterfield, Missouri, United States, 63017|
|Principal Investigator:||Janine M Hall-Porter, PhD||St. Luke's Hospital|