Zolpidem extended-release 12.5 mg associated with improvements in work performance in a 6-month randomized, placebo-controlled trial.
Sleep
; 31(10): 1371-8, 2008 Oct.
Article
in En
| MEDLINE
| ID: mdl-18853934
ABSTRACT
BACKGROUND:
Although most research on pharmacotherapy for chronic insomnia focuses on changes in sleep outcomes, the functional impact of treatment is also of great importance to patients, families, physicians, and employers.OBJECTIVE:
To analyze changes in functioning at work (or work performance) among a subset of employed subjects (N = 752) from a 24-week, randomized, double-blind, placebo-controlled trial of zolpidem extended-release 12.5 mg taken nightly, at least 3 nights per week, by healthy adults with chronic insomnia.METHODS:
Using 2 scales (Time Management and Work Output) from the Work Limitations Questionnaire (WLQ), subjects' health-related work limitations were evaluated at baseline, week 4, week 12, and week 24 (end of study) or premature discontinuation. To compare zolpidem extended-release 12.5 mg with placebo, within-group and between-group differences were analyzed and effect sizes were computed. The relationship of WLQ scores to scores on the Patient Global Impression, Item 1 (PGI-1), scale, the primary outcome measure for benefit to sleep, was also analyzed. Data were obtained from August 31, 2004 through January 6, 2006.RESULTS:
Scores on both WLQ scales were substantially elevated at baseline in this population, reflecting impairment relative to healthy controls. The zolpidem extended-release 12.5 mg group had significantly greater improvement at all time points on the WLQ Time Management (P < 0.0001) and Work Output (P < 0.01) scales. Effect size analysis confirmed the clinical relevance of these improvements. Subjects rating their sleep as improved on the PGI-1 had significantly greater improvement on both WLQ scales at week 12 than did those who reported no benefit or worsening (P < 0.01).CONCLUSIONS:
Employed adults with chronic insomnia treated with zolpidem extended-release 12.5 mg experienced significantly improved work performance over 24 weeks.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pyridines
/
Wakefulness
/
Employee Performance Appraisal
/
Hypnotics and Sedatives
/
Sleep Initiation and Maintenance Disorders
Type of study:
Clinical_trials
/
Risk_factors_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Sleep
Year:
2008
Type:
Article
Affiliation country:
United States