Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
Information source: St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep; Memory
Intervention: zaleplon (Drug); zolpidem extended release (Drug); bedtime placebo (Drug); middle of the night placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: St. Luke's Hospital, Chesterfield, Missouri Official(s) and/or principal investigator(s): Janine M Hall-Porter, PhD, Principal Investigator, Affiliation: St Luke's Hospital
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.
Clinical Details
Official title: Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
Primary outcome: Memory
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
St. Luke's Hospital Sleep Medicine and Research Center, Chesterfield, Missouri 63017, United States
Additional Information
Related 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. Weinling 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.
Starting date: October 2010
Last updated: August 25, 2014
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