Summary

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• Wakix (pitolisant) is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
• This summary is based on the review of six systematic review(s)/meta-analysis(es). ^[1-6]
• Excessive Daytime Sleepiness (EDS) in Obstructive Sleep Apnea (OSA): Pitolisant reduces ESS scores (MD -2.78 [95% CI, -4.03 to -1.51]; moderate certainty) but probably does not significantly improve Maintenance of Wakefulness Test (MWT) scores (moderate certainty). Improved Oxford Sleep Resistance (OSleR) test scores by 1.18 (1.02; 1.35, p = 0.022) and reduced fatigue in 30% more patients (RR = 1.3 [1.11; 1.53], p = 0.001).
• Narcolepsy: Pitolisant was superior to placebo in reducing ESS scores but was less effective than solriamfetol (MD -2.88, 95% CI -4.89 to -0.88). Solriamfetol was also superior to pitolisant in improving MWT scores (SMD 0.45, 95% CI 0.02-0.88). Pitolisant increased EQ-5D scores by MD of 3.32 points (95% CI: 0.26-6.39) compared with placebo.
• General Effectiveness in Narcolepsy and OSA: Pitolisant significantly decreased ESS by MD of -2.86 points (95% CI: -3.75 to -1.96) and increased mean sleep latency by MD of 3.14 min (95% CI: 2.18-4.11).
• The risk ratio of treatment-emergent adverse events (TEAEs) with pitolisant was 1.37 (95% CI: 1.08-1.74) compared to placebo, with insomnia being the only TEAE significantly associated with pitolisant treatment.
• Pitolisant had fewer and shorter adverse effects compared to modafinil in patients with severe narcolepsy symptoms and was generally well-tolerated in this population.
• Patients with OSA showed benefits in reducing ESS scores, improving fatigue, CGI, mobility, and quality of life, particularly in those not using continuous positive airway pressure therapy. In patients with severe narcolepsy symptoms, pitolisant demonstrated better tolerance compared to modafinil.