Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea

Schwartz, Jonathan R.L.; Hirshkowitz, Max; Erman, Milton K.; Schmidt-Nowara, Wolfgang

doi:10.1378/chest.124.6.2192

Cited by 109Obstructive Sleep Apnea ResearchSleep and related disordersSleep and Work-Related Fatigue

Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea

Schwartz, Jonathan R.L., Hirshkowitz, Max, Erman, Milton K., Schmidt-Nowara, Wolfgang·2003·Chest

DOI 10.1378/chest.124.6.2192

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Abstract

Study objectives The purpose of this 12-week study was to evaluate the efficacy and safety of adjunct modafinil to treat excessive sleepiness in patients with obstructive sleep apnea (OSA) who experience residual sleepiness despite regular nasal continuous positive airway pressure (nCPAP) use. Design Twelve-week, open-label trial. Setting Twenty-two centers in the United States. Patients We studied 125 patients with moderate-to-severe OSA (ie, respiratory disturbance index > or =15) before nCPAP therapy and residual daytime sleepiness (Epworth sleepiness scale [ESS] score > or =10) despite effective and regular nCPAP therapy. Patients were studied after completing a 4-week, double-blind, placebo-controlled trial of nCPAP plus modafinil for the treatment of residual daytime sleepiness. Interventions and measurements Patients received individually titrated doses of modafinil (200 to 400 mg qd). Sleepiness was assessed using the ESS, quality of life was evaluated using the Functional Outcomes of Sleep Questionnaire (FOSQ), and the overall clinical effect was indexed using the clinical global impression of change scale. Adverse events, nCPAP use, and vital sign measurements were also recorded. Results The significant improvements in daytime wakefulness and sleep-related functional status observed with modafinil treatment during the 4-week, double-blind study were maintained throughout 12 weeks of open-label treatment: week 12 ESS, 7.8 (4.7) vs 14.4 (3.1) at double-blind baseline; week 12 FOSQ, 3.3 (0.6) vs 14.4 (2.7) at double-blind baseline (mean [SD]). The percentage of patients rated as clinically improved increased from 83% after 1 week to > or =93% after 2 to 12 weeks of open-label treatment. Mean (SD) nCPAP use decreased from 6.3 (1.3) h/night at baseline to 5.9 (1.4) h/night (p = 0.004) during open-label treatment. The most common adverse events were headache (28%), anxiety (16%), and nervousness (14%). Conclusions Modafinil remained effective and well tolerated as an adjunct therapy for residual daytime sleepiness even after 12 weeks of daily dosing in patients with OSA receiving nCPAP 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).”
From Medical Therapy for Obstructive Sleep Apnea: A Review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine (2006) · cites this paper as [75]
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]”
From Medical Therapy for Obstructive Sleep Apnea: A Review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine (2006) · cites this paper as [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.”
From Medical Therapy for Obstructive Sleep Apnea: A Review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine (2006) · cites this paper as [75]

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Authors: Schwartz, J. R. L., Hirshkowitz, M., Erman, M. K., & Schmidt-Nowara, W.
Affiliations: INTEGRIS Baptist Medical Center (US)
Veterans Health Administration (US)
Corresponding author: Schwartz, Jonathan R.L.
ORCID: Hirshkowitz, Max
Venue: Chest
Publisher: Elsevier BV
Published: 2003-12
Volume: 124
Issue: 6
Pages: 2192-2199
ISSN: 0012-3692 (ISSN-L)
DOI: 10.1378/chest.124.6.2192
OpenAlex: W2163375570
Cited by: 107
References: 39
Citations by year: 2024: 3 · 2023: 4 · 2022: 1 · 2021: 1 · 2020: 1 · 2018: 2 · 2017: 5 · 2016: 6 · 2015: 5 · 2014: 3 · 2013: 5 · 2012: 7
FWCI: 2.88
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: CHEST Journal (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
Keywords: modafinil, obstructive sleep apnea, daytime sleepiness, residual daytime sleepiness, adjunctive therapy, continuous positive airway pressure, Epworth Sleepiness Scale, quality of life, adverse events, long-term efficacy, wakefulness-promoting agents, headache, anxiety, Functional Outcomes of Sleep Questionnaire, clinical global impression
MeSH terms: Modafinil, Adult, Aged, Central Nervous System Stimulants, Benzhydryl Compounds, Double-Blind Method, Female, Humans, Male, Middle Aged, Chemotherapy, Adjuvant, Sleep Disorders, Circadian Rhythm, Sleep Apnea, Obstructive, Continuous Positive Airway Pressure

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Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea

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