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

NCT01159652 | Completed Phase 4

• 1 other identifier: 63-SR-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Memory

Keywords

sleep; memory; hypnotics; zaleplon; zolpidem; Sonata; Ambien; Hypnotics and Sedatives; Polysomnography; Monitoring, sleep

Outcome Measures

Primary Outcomes (1)

• Memory

  Two memory tasks will be used to assess memory.

  8 timepoints: 4 evenings and 4 mornings

Study Arms (4)

Bedtime Placebo

PLACEBO COMPARATOR

Drug: bedtime placebo

Middle of the Night Placebo

PLACEBO COMPARATOR

Drug: middle of the night placebo

Zolpidem

EXPERIMENTAL

Drug: zolpidem extended release

Zaleplon

EXPERIMENTAL

Drug: zaleplon

Interventions

zaleplon DRUG

10 mg

Also known as: Sonata

Zaleplon

zolpidem extended release DRUG

12.5 mg

Also known as: Ambien CR

Zolpidem

bedtime placebo DRUG

placebo

Bedtime Placebo

middle of the night placebo DRUG

placebo

Middle of the Night Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital, Chesterfield, Missouri: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

St. Luke's Hospital Sleep Medicine and Research Center

Chesterfield, Missouri, 63017, United States

Location

Related Publications (2)

• 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. doi: 10.1016/S0009-9236(98)90139-4.

  PMID: 9834048 BACKGROUND

• 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. doi: 10.1111/j.1472-8206.2006.00415.x.

  PMID: 16867025 BACKGROUND

MeSH Terms

Interventions

zaleplon; Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janine M Hall-Porter, PhD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

US (1)