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 (≥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.
Similar content being viewed by others
References
American Sleep Disorders Association (1997) The international classification of sleep disorders, revised. Diagnostic and coding manual. American Sleep Disorders Association, Rochester, Minn.
Baranski J, Cian C, Esquivie D et al. (1998) Modafinil during 64 hr of sleep deprivation: dose-related effects on fatigue, alertness, and cognitive performance. Milit Psychol 10:173–193
Beusterien KM, Rogers AE, Walsleben JA, Emsellem HA, Reblando JA, Wang L, Goswami M, Steinwald B (1999) Health-related quality of life effects of modafinil for treatment of narcolepsy. Sleep 22:757–765
Broughton R, Ghanem Q, Hishikawa Y, Sugita Y, Nevsimalova S, Roth B (1981) Life effects of narcolepsy in 180 patients from North America, Asia and Europe compared to matched controls. Can J Neurol Sci 8:299–304
Broughton RJ, Fleming JAE, George CFP, Hill JD, Kryger MH, Moldofsky H, Montplaisir JY, Morehouse RL, Moscovitch A, Murphy WF (1997) Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy. Neurology 49:444–451
Douglas NJ (1998) The psychosocial aspects of narcolepsy. Neurology 50:S27–S30
Goswami M (1998) The influence of clinical symptoms on quality of life in patients with narcolepsy. Neurology 50:S31–S36
Guy W (1976) ECDEU Assessment manual for psychopharmacology, revised. US Department of Health, Education, and Welfare, Rockville, Md.
Holland JC, Korzun AH, Tross S (1986) Comparative psychological disturbance in patients with pancreatic and gastric cancer. Am J Psychiatry 143:982–986
Horrigan JP, Barnhill LJ (2000) Low-dose amphetamine salts and adult attention-deficit/hyperactivity disorder. J Clin Psychiatry 61:414–417
Hublin C, Partinen M, Kaprio J, Koskenvuo M, Guilleminault C (1994) Epidemiology of narcolepsy. Sleep 17:S7–S12
Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep 14:540–545
Krishnan RR, Volow MR, Miller PP, Carwile ST (1984) Narcolepsy: preliminary retrospective study of psychiatric and psychosocial aspects. Am J Psychiatry 141:428–431
Lin L, Hungs M, Mignot E (2001) Narcolepsy and the HLA region. J Neuroimmunol 117:9–20
Lorr M, McNair DM, Weinstein GJ (1964) Early effects of chlordiazepoxide (Librium) used with psychotherapy. J Psychiatr Res 1:257–270
McHorney CA, Ware JE Jr, Raczek AE (1993) The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31:247–263
McHorney CA, Ware JE Jr, Lu JFR, Sherbourne CD (1994) The MOS 36-Item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 32:40–66
McNair DM, Lorr M, Droppleman LF (1992) Profile of Mood States (POMS) manual. Educational and Industrial Testing Service, San Diego, Calif.
Mignot E, Lammers GJ, Ripley B, Okum M, Nevsimalova S, Overeem S, Vankova J, Black J, Harsh J, Bassetti C, Schrader H, Nishino S (2002) The role of cerebrospinal fluid hypocretin measurement in the diagnosis of narcolepsy and other hypersomnias. Arch Neurol 59:1553–1562
Mosko S, Zetin M, Glen S, Garber D, DeAntonio M, Sassin J, McAnich J, Warren S (1989) Self-reported depressive symptomatology, mood ratings, and treatment outcome in sleep disorders patients. J Clin Psychol 45:51–60
Palfai T, Jankiewicz H (1991) Amphetamine and cocaine. In: Ring DM (ed) Drugs and human behavior. Brown, Dubuque, pp 281–309
Pigeau R, Naitoh P, Buguet A, McCann C, Baranski J, Taylor M, Thompson M, Mack II (1995) Modafinil, d-amphetamine and placebo during 64 hours of sustained mental work. I. Effects on mood, fatigue, cognitive performance and body temperature. J Sleep Res 4:212–228
Roy A (1976) Psychiatric aspects of narcolepsy. Br J Psychiatry 128:562–565
Schwartz J, Feldman N, Fry J, et al (2003) Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants. Sleep Med 4:43–49
Stivalet P, Esquivié D, Barraud P-A, Leifflen D, Raphel C (1998) Effects of modafinil on attentional processes during 60 hours of sleep deprivation. Hum Psychopharmacol Clin Exp 13:501–507
Turner DC, Robbins TW, Clark L, Aron AR, Dowson J, Sahakian BJ (2003) Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology 165:260–269
US Modafinil in Narcolepsy Multicenter Study Group (1998) Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. Ann Neurol 43:88–97
US Modafinil in Narcolepsy Multicenter Study Group (2000) Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy. Neurology 54:1166–1175
Ware JE Jr, Sherbourne CD (1992) The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual framework and item selection. Med Care 30:473–483
Ware JE, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A (1995) Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 33: AS264–A279
Acknowledgement
The study was supported by Cephalon, Inc., West Chester, Pa.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Becker, P.M., Schwartz, J.R.L., Feldman, N.T. et al. Effect of modafinil on fatigue, mood, and health-related quality of life in patients with narcolepsy. Psychopharmacology 171, 133–139 (2004). https://doi.org/10.1007/s00213-003-1508-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00213-003-1508-9