Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy

Publication date: Available online 7 October 2017
Source:Sleep Medicine
Author(s): Yves Dauvilliers, Thomas Roth, Diane Guinta, Sarah Alvarez-Horine, Efim Dynin, Jed Black
ObjectiveTo assess the effects of three narcolepsy treatment modalities on sleep stage shifts associated with disrupted nighttime sleep (DNS) using data from a clinical trial.MethodsPolysomnograms were reviewed from 155 patients (who had these data available at baseline and 8 weeks) of the 278 patients who were randomized to placebo, 9-g sodium oxybate (SXB)/nightly, 200−600 mg/d modafinil, or SXB+modafinil. Major outcomes of these post hoc analyses, analyzed using analysis of covariance, were change from baseline in number of shifts from Stages N2/3/rapid eye movement (REM) to Stage N1/Wake, and from Stage N1/Wake to REM. Sleep quality was evaluated using the sleep-quality question from the Pittsburgh Sleep Quality Index.ResultsSXB alone or in combination with modafinil significantly decreased the number of shifts from Stage N2/3/REM to Stage N1/Wake (p < 0.01); least-squares mean change in number of shifts from baseline was –0.6, –16.5, 1.8, and –13.7 in the placebo, SXB, modafinil and SXB+modafinil groups, respectively. A similar pattern was observed for changes in shifts from REM to Stage N1/Wake and from Stage N1/Wake to REM. Relative to placebo, sleep quality significantly improved with SXB and SXB+modafinil (p ≤ 0.05) but not with modafinil alone.ConclusionThese results show that SXB with and without modafinil significantly consolidated sleep and improved patient-reported sleep quality relative to placebo. In contrast, no such effects were observed with modafinil alone, suggesting a specific effect of SXB on DNS in addition to its effect on daytime sleepiness.Clinicaltrials.gov identifierNCT00066170.



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