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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Bedtime Placebo

Group Type PLACEBO_COMPARATOR

bedtime placebo

Intervention Type DRUG

placebo

Middle of the Night Placebo

Group Type PLACEBO_COMPARATOR

middle of the night placebo

Intervention Type DRUG

placebo

Zolpidem

Group Type EXPERIMENTAL

zolpidem extended release

Intervention Type DRUG

12.5 mg

Zaleplon

Group Type EXPERIMENTAL

zaleplon

Intervention Type DRUG

10 mg

Interventions

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zaleplon

10 mg

Intervention Type DRUG

zolpidem extended release

12.5 mg

Intervention Type DRUG

bedtime placebo

placebo

Intervention Type DRUG

middle of the night placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Sonata Ambien CR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes