Modafinil for excessive daytime sleepiness: A systematic review and meta-analysis of randomized controlled trials
Abstract
Background: Excessive daytime sleepiness (EDS) is a common and disabling symptom of obstructive sleep apnea (OSA) and shift work sleep disorder (SWSD). Modafinil is widely used as a wakefulness-promoting agent; however, its efficacy and safety remain debatable.
Objective: To evaluate the efficacy and safety of modafinil for EDS in adults with OSA or SWSD.
Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). MEDLINE/PubMed, EMBASE, LILACS, and CENTRAL were searched from inception to May 2026, along with clinical trial registries. Eligible studies compared modafinil with placebo in adults with EDS related to OSA or SWSD. The primary outcomes were daytime sleepiness, assessed using the Epworth Sleepiness Scale (ESS), and objective wakefulness, assessed using the Maintenance of Wakefulness Test (MWT). The secondary outcomes included clinical global improvement (CGI-C), vigilance performance, and adverse events (AEs). The risk of bias was assessed using RoB2, and the certainty of the evidence was assessed using GRADE.
Results: Nine RCTs (1265 participants) were included in this review. In patients with OSA, continuous ESS analyses, both change-from-baseline and endpoint, did not demonstrate statistically significant differences between the modafinil and placebo groups. Clinical response analyses based on the predefined ESS responder criteria generally favored the use of modafinil. For objective wakefulness, pooled MWT endpoint…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,265 participants or records.
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