Modafinil for Treatment of Residual Excessive Sleepiness in Nasal Continuous Positive Airway Pressure-Treated Obstructive Sleep Apnea/Hypopnea Syndrome
Abstract
STUDY OBJECTIVES: Nasal continuous positive airway pressure (nCPAP) usually reduces sleepiness in patients with obstructive sleep apnea/hypopnea syndrome. However, even with regular use of nCPAP, some patients experience residual excessive sleepiness. We evaluated the efficacy and safety of the wake-promoting agent modafinil for treating residual excessive sleepiness in nCPAP-treated patients. DESIGN: 12-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. PATIENTS: Patients aged 18 to 70 years diagnosed with obstructive sleep apnea/hypopnea syndrome and having residual excessive sleepiness during nCPAP therapy were eligible. INTERVENTIONS: Once-daily modafinil, 200 mg or 400 mg, or placebo. MEASUREMENTS AND RESULTS: Assessments included the Maintenance of Wakefulness Test, Epworth Sleepiness Scale, Clinical Global Impression of Change, and Functional Outcomes of Sleep Questionnaire. Both doses of modafinil significantly improved mean (SD) sleep latency on the Maintenance of Wakefulness Test at weeks 4, 8, and 12 compared with placebo (week 12: modafinil 400 mg, 15.0 [5.3] minutes; 200 mg, 14.8 [5.3] minutes; placebo, 12.6 [5.8] minutes; P < .0001). The Epworth Sleepiness Scale score decreased more in patients taking modafinil compared with those in the placebo group (week 12: modafinil 400 mg, -4.5 [4.3]; 200 mg, -4.5 [4.7]; placebo, -1.8 [3.5]; P < .0001). At week 12, overall clinical condition improved for 61% and 68% of patients treated with modafinil 200 mg and 400 mg, respectively, versus 37% of placebo-treated patients (P < .001). Modafinil was generally well tolerated and did not adversely affect nighttime sleep or nCPAP use. CONCLUSIONS: These results confirm previous shorter-term controlled trials, indicating modafinil is a useful adjunct therapy for improving wakefulness in patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome who were treated with nCPAP.
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Modafinil has no effect on the AHI but reduces objective sleepiness by approximately one minute.
“This drug has no effect on the AHI, 71,72 but has been shown to reduce objective sleepiness by approximately one minute.[70][71][72][73][74][75]”
Modafinil consistently improved subjective and objective sleepiness, quality of life and vigilance compared to placebo.
“Modafinil consistently (across studies) improved subjective and objective sleepiness, quality of life and vigilance compared to placebo.”
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- Authors
- Black, J. E., & Hirshkowitz, M.
- Affiliations
- Stanford Medicine (US)
- Baylor College of Medicine (US)
- Corresponding author
- Black, Jed E.
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-04
- Volume
- 28
- Issue
- 4
- Pages
- 464-471
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- OpenAlex
- W144263799
- Cited by
- 172
- References
- 39
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 4 · 2023: 5 · 2022: 5 · 2021: 11 · 2020: 3 · 2019: 1 · 2018: 5 · 2017: 8 · 2016: 9 · 2015: 5 · 2014: 6 · 2013: 8 · 2012: 5
- FWCI
- 10.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- SLEEP (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Keywords
- modafinil, obstructive sleep apnea-hypopnea syndrome, nasal continuous positive airway pressure, wakefulness-promoting agents, sleep latency, daytime sleepiness, adjunctive therapy, treatment safety, Epworth Sleepiness Scale, maintenance of wakefulness test, dose comparison, CPAP tolerance, quality of life
- MeSH terms
- Modafinil, Adolescent, Adult, Aged, Central Nervous System Stimulants, Benzhydryl Compounds, Double-Blind Method, Female, Humans, Disorders of Excessive Somnolence, Male, Middle Aged, Surveys and Questionnaires, Severity of Illness Index, Wakefulness, Treatment Outcome, Sleep Apnea, Obstructive, Continuous Positive Airway Pressure
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