Effect of modafinil on fatigue, mood, and health-related quality of life in patients with narcolepsy.

Abstract

INTRODUCTION:

In addition to excessive sleepiness, patients with narcolepsy often have significant fatigue, depressed mood, and decreased quality of life.

OBJECTIVE:

To determine whether treatment with modafinil for excessive sleepiness improves fatigue, mood, and health-related quality of life (HRQOL) in patients with narcolepsy.

MATERIALS AND METHODS:

Outpatients with narcolepsy underwent a 14-day washout of psychostimulants and then were enrolled in this 6-week, open-label, multicenter study. Patients received modafinil starting at 200 mg once daily for week 1, and then 200 or 400 mg daily for weeks 2 through 6. Efficacy was evaluated using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS). Safety was assessed by monitoring adverse events (AE).

RESULTS:

At baseline, 151 patients had moderate to severe excessive sleepiness (mean Epworth Sleepiness Scale score=17.8+/-4.4). Most patients (> or =70% of 123 who completed the study) received 400 mg modafinil once daily during weeks 2 through 6. Modafinil significantly improved HRQOL, based on SF-36 measures of mental and physical component summary scores and subdomain scores of role-physical, social functioning, and vitality (each P<0.001). Modafinil treatment was also associated with significantly reduced fatigue and significantly improved vigor and cognition as assessed by the POMS (each P<0.001) from weeks 1 through 6. The most frequent AE with modafinil treatment were headache, nausea, and insomnia; most AE were mild or moderate in nature. Only seven patients (5%) withdrew from the study because of AE.

CONCLUSION:

In narcolepsy patients who were switched from psychostimulants, modafinil therapy improved HRQOL and subjective feelings of vigor and cognitive functioning and reduced fatigue.

• Authors: Philip M Becker, Jonathan R L Schwartz, Neil T Feldman, Rod J Hughes
• Journal: Psychopharmacology (Psychopharmacology (Berl)) Vol. 171 Issue 2 Pg. 133-9 (Jan 2004) ISSN: 0033-3158 [Print] Germany
• PMID: 14647965 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Benzhydryl Compounds
• Central Nervous System Stimulants
• Modafinil

Topics

• Adolescent
• Adult
• Affect (drug effects)
• Aged
• Benzhydryl Compounds (administration & dosage, adverse effects, therapeutic use)
• Central Nervous System Stimulants (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Fatigue (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Modafinil
• Narcolepsy (drug therapy, psychology)
• Psychiatric Status Rating Scales
• Quality of Life (psychology)
• Treatment Outcome
• Wakefulness (drug effects)