What question did this study set out to answer?

This research aims to review and analyze the effectiveness and safety of pitolisant for treating excessive daytime sleepiness in obstructive sleep apnea patients using CPAP.

May 10, 2026

0666 Efficacy, Tolerability, and Safety of Pitolisant for Residual Sleepiness in Obstructive Sleep Apnea Treated with CPAP

Key Points

This research aims to review and analyze the effectiveness and safety of pitolisant for treating excessive daytime sleepiness in obstructive sleep apnea patients using CPAP.
Systematic review of randomized controlled trials comparing pitolisant to placebo in adults with obstructive sleep apnea (OSA) and residual excessive daytime sleepiness.
Primary outcome measured was change in subjective sleepiness using validated scales, secondary outcomes included all-cause discontinuation and treatment-emergent adverse events.
Risk assessment and certainty of evidence were conducted using standard models and methods.
Pitolisant significantly reduced Epworth Sleepiness Scale scores (SMD = -0.90, 95% CI = -1.29 to -0.50; moderate certainty).
No significant differences were observed between pitolisant and placebo for all-cause discontinuation (Log RR = 0.76, 95% CI = 0.25 to 2.34; low certainty) or treatment-emergent adverse events (Log RR = 1.04, 95% CI = 0.83 to 1.31; low certainty).
Common adverse events included headache and insomnia during pitolisant use.

Abstract

Abstract Introduction To systematically review and meta-analyze the efficacy, tolerability, and safety of pitolisant for the treatment of residual excessive daytime sleepiness (EDS) in adults with obstructive sleep apnea (OSA) treated with continuous positive airway pressure (CPAP). Methods Systematic review (MEDLINE/EMBASE/Cochrane/PsycINFO/clinical trial registries, 01/02/2025) of randomized controlled trials (RCTs) comparing pitolisant to placebo in adults with OSA and residual EDS despite CPAP use. The primary outcome was change in subjective sleepiness measured on any validated scale. Secondary outcomes included all-cause discontinuation and treatment-emergent adverse events (TEAEs). A random-effects model was used to calculate standardized mean differences (SMDs) and pooled Log risk ratios (Log RRs) with 95% confidence intervals (CI). Risk of bias was assessed with Cochrane RoB2. Certainty of evidence was assessed with GRADE. Results Three RCTs (N = 721) were included. Pitolisant significantly reduced Epworth Sleepiness Scale scores (SMD = -0.90, 95% CI = -1.29 to -0.50; moderate certainty). There were no significant differences between pitolisant and placebo for all-cause discontinuation (Log RR = 0.76, 95% CI = 0.25 to 2.34; low certainty) or TEAEs (Log RR = 1.04, 95% CI = 0.83 to 1.31; low certainty). The most common adverse events reported while using pitolisant were headache and insomnia. Conclusion Pitolisant is an effective and well-tolerated treatment for reducing subjective EDS in patients with OSA on CPAP therapy. These findings support its potential as a therapeutic option in this population. Future studies should include larger sample sizes and objective measures of sleepiness. Support (if any)

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