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: June 27, 2013
Last verified: June 2013

July 8, 2010
June 27, 2013
October 2010
May 2011   (final data collection date for primary outcome measure)
Memory [ Time Frame: 8 timepoints: 4 evenings and 4 mornings ] [ Designated as safety issue: No ]
Two memory tasks will be used to assess memory.
Same as current
Complete list of historical versions of study NCT01159652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
  • Sleep
  • Memory
  • Drug: zaleplon
    10 mg
    Other Name: Sonata
  • Drug: zolpidem extended release
    12.5 mg
    Other Name: Ambien CR
  • Drug: bedtime placebo
    placebo
  • Drug: middle of the night placebo
    placebo
  • Placebo Comparator: Bedtime Placebo
    Intervention: Drug: bedtime placebo
  • Placebo Comparator: Middle of the Night Placebo
    Intervention: Drug: middle of the night placebo
  • Experimental: Zolpidem
    Intervention: Drug: zolpidem extended release
  • Experimental: Zaleplon
    Intervention: Drug: zaleplon

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01159652
63-SR-10
No
St. Luke's Hospital, Chesterfield, Missouri
St. Luke's Hospital, Chesterfield, Missouri
American Academy of Sleep Medicine
Principal Investigator: Janine M Hall-Porter, PhD St Luke's Hospital
St. Luke's Hospital, Chesterfield, Missouri
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP