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Hypnotic Medications and Memory: Effect of Drug Exposure During the Night

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159652
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : August 26, 2014
American Academy of Sleep Medicine
Information provided by (Responsible Party):
St. Luke's Hospital, Chesterfield, Missouri

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Placebo Comparator: Bedtime Placebo Drug: bedtime placebo

Placebo Comparator: Middle of the Night Placebo Drug: middle of the night placebo

Experimental: Zolpidem Drug: zolpidem extended release
12.5 mg
Other Name: Ambien CR

Experimental: Zaleplon Drug: zaleplon
10 mg
Other Name: Sonata

Primary Outcome Measures :
  1. Memory [ Time Frame: 8 timepoints: 4 evenings and 4 mornings ]
    Two memory tasks will be used to assess memory.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 to 50 years of age
  • no sleep complaints or problems
  • good sleep quality per questionnaire
  • sufficient time in bed each night

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01159652

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United States, Missouri
St. Luke's Hospital Sleep Medicine and Research Center
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
St. Luke's Hospital, Chesterfield, Missouri
American Academy of Sleep Medicine
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Principal Investigator: Janine M Hall-Porter, PhD St. Luke's Hospital
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Responsible Party: St. Luke's Hospital, Chesterfield, Missouri Identifier: NCT01159652    
Other Study ID Numbers: 63-SR-10
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014
Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
Hypnotics and Sedatives
Monitoring, sleep
Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators