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

This study has been completed.
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by (Responsible Party):
St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT01159652
First received: July 8, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Sleep
Memory
Drug: zaleplon
Drug: zolpidem extended release
Drug: bedtime placebo
Drug: middle of the night placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Chesterfield, Missouri:

Primary Outcome Measures:
  • Memory [ Time Frame: 8 timepoints: 4 evenings and 4 mornings ] [ Designated as safety issue: No ]
    Two memory tasks will be used to assess memory.


Enrollment: 26
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Bedtime Placebo Drug: bedtime placebo
placebo
Placebo Comparator: Middle of the Night Placebo Drug: middle of the night placebo
placebo
Experimental: Zolpidem Drug: zolpidem extended release
12.5 mg
Other Name: Ambien CR
Experimental: Zaleplon Drug: zaleplon
10 mg
Other Name: Sonata

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159652

Locations
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
Investigators
Principal Investigator: Janine M Hall-Porter, PhD St Luke's Hospital
  More Information

Publications:
Responsible Party: St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT01159652     History of Changes
Other Study ID Numbers: 63-SR-10
Study First Received: July 8, 2010
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
sleep
memory
hypnotics
zaleplon
zolpidem
Sonata
Ambien
Hypnotics and Sedatives
Polysomnography
Monitoring, sleep

Additional relevant MeSH terms:
Zolpidem
Zaleplon
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
GABA Modulators

ClinicalTrials.gov processed this record on September 22, 2014