Wakefulness-promoting agents effective for excessive daytime sleepiness but patients may discontinue due to side effects


A systematic review and analysis of 14 trials found that solriamfetol, armodafinil–modafinil, and pitolisant reduce excessive daytime sleepiness (ESA) for patients with obstructive sleep apnea (OSA) already using conventional therapy. However, patients may be more likely to discontinue the use of these medications due to adverse events including headache, anxiety, and insomnia. The review is published in Annals of Internal Medicine.

Symptoms of EDS are often improved with standard treatment of OSA, but it may persist in up to 18 percent of OSA patients despite ongoing conventional therapy. EDS is associated with neuropsychological impairment and decreased quality of life, and treatment is a continued priority for clinicians. Pharmacological interventions for OSA include solriamfetol and armodafinil–modafinil, which are approved for OSA treatment in the U.S., and pitolisant, which has been studied in previous trials but is not approved for treatment of OSA.

Researchers from McMaster University, Dalhousie University, and the University of Toronto conducted a systematic review and meta-analysis of 14 trials enrolling 3,085 patients and included the use of armodafinil, modafinil, solriamfetol, and pitolisant–H3-autoreceptor antagonist. The authors found that solriamfetol, armodafinil–modafinil and pitolisant reduced daytime sleepiness for patients with OSA already on conventional therapy, and solriamfetol was likely superior in effectiveness. However, adverse events including headache, insomnia, and anxiety were associated with an increased risk for discontinuation in several trials.

According to the authors, future research should address potential long-term and rare harms that may be associated with these drugs and potential differential effects of these drugs in patients who are not adherent to conventional OSA treatment.

More information:
Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea, Annals of Internal Medicine (2023). DOI: 10.7326/M22-3473

Journal information:
Annals of Internal Medicine

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