Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea
Abstract
Patients with obstructive sleep apnea/hypopnea syndrome can experience residual daytime sleepiness despite regular use of nasal continuous positive airway pressure therapy. This randomized, double-blind, placebo-controlled, parallel group study assessed the efficacy and safety of modafinil for the treatment of residual daytime sleepiness in such patients. Patients received modafinil (n = 77) (200 mg/d, Week 1; 400 mg/d, Weeks 2 to 4) or matching placebo (n = 80) once daily for 4 wk. Modafinil significantly improved daytime sleepiness, with significantly greater mean changes from baseline in Epworth Sleepiness Scale scores at Weeks 1 and 4 (p < 0.001) and in multiple sleep latency times (MSLT) at Week 4 (p < 0.05). The percentage of patients with normalized daytime sleepiness (Epworth score < 10) was significantly higher with modafinil (51%) than with placebo (27%) (p < 0.01), but not for MSLT (> 10 min; 29% versus 25%). Headache (modafinil, 23%; placebo, 11%; p = 0.044) and nervousness (modafinil, 12%; placebo, 3%; p = 0.024) were the most common adverse events. During modafinil or placebo treatment, the mean duration of nCPAP use was 6.2 h/night, with no significant change from baseline observed between groups. Modafinil may be a useful adjunct treatment for the management of residual daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome who are regular users of nasal continuous positive airway pressure therapy.
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The negative effect of modafinil on nightly nasal CPAP usage was not found in the other two double-blind studies of longer duration or in the open-label continuation study.
“This negative effect was not found in the other two doubleblind studies of longer duration 71,72 or in the open-label continuation study (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.”
There is a concern that compliance with CPAP may fall with modafinil usage.
“There is a concern that compliance with CPAP may fall with modafinil usage, 72 and this requires further study.”
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]”
A two-week placebo-controlled study with one dose (400 mg) of modafinil demonstrated a modest but significant reduction in nightly nasal CPAP usage.
“A two-week, placebo-controlled study with one dose (400 mg) of modafinil 72 demonstrated that patients using this stimulant had a modest but significant reduction in their nightly usage of nasal CPAP.”
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References 76 · Cited by 324
- Authors
- PACK, A. I., BLACK, J. E., SCHWARTZ, J. R. L., & MATHESON, J. K.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2001-11-01
- Volume
- 164
- Issue
- 9
- Pages
- 1675-1681
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- OpenAlex
- W2128103058
- Cited by
- 324
- References
- 76
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 8 · 2023: 7 · 2022: 13 · 2021: 14 · 2020: 3 · 2019: 4 · 2018: 10 · 2017: 4 · 2016: 8 · 2015: 11 · 2014: 7 · 2013: 17 · 2012: 9
- FWCI
- 8.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Respiratory and Critical Care Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- ResMed
- 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, daytime sleepiness, residual daytime sleepiness, adjunctive therapy, continuous positive airway pressure, Epworth Sleepiness Scale, multiple sleep latency test, headache, anxiety, adverse events
- MeSH terms
- Modafinil, Adult, Aged, Central Nervous System Stimulants, Analysis of Variance, Benzhydryl Compounds, Combined Modality Therapy, Consumer Product Safety, Double-Blind Method, Female, Humans, Male, Middle Aged, Positive-Pressure Respiration, Severity of Illness Index, Sleep Stages, Polysomnography, Statistics, Nonparametric, Sleep Apnea, Obstructive
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