Modafinil 200mg tablets

Background and objectivesResidual sleepiness can occur in adult patients with obstructive sleep apnea (OSA) despite adequate treatment with continuous positive airway pressure (CPAP). Various wake-promoting agents (WPAs) have been shown to reduce residual sleepiness in CPAP-treated patients with OSA. This systematic review and network meta-analysis aimed to compare the efficacy and safety of WPAs in this setting.MethodsWe searched MEDLINE, Scopus, and ClinicalTrials.gov up to 9 January 2025 for randomized controlled trials (RCTs) examining WPAs for treating sleepiness in patients with OSA. Included were all RCTs that explored the efficacy and/or safety of any approved WPAs (i.e., modafinil, armodafinil, solriamfetol, or pitolisant) in patients with OSA (aged ≥ 18 years) treated with CPAP but who are still sleepy [Epworth sleepiness scale (ESS) score ≥10]. Studies that were conducted in patients whose comorbidities cause daytime somnolence [i.e., psychiatric conditions (other than depression), other sleep disorders, medical or surgical conditions], open label extension studies, and studies published in a language other than English were excluded. The primary outcomes included ESS, maintenance of wakefulness test (MWT), and adverse events. Two authors independently assessed the risk of bias using the revised Cochrane risk-of-bias tool for randomized trials 2.0.ResultsIn total, 14 RCTs studying four WPAs (total N = 2969) including modafinil (six RCTs; 200-400 mg/day), armodafinil (four RCTs; 150-250mg/day), solriamfetol (two RCTs; 37.5-300 mg/day), and pitolisant (two RCTs; 5-40 mg/day) were included. Solriamfetol, modafinil, and armodafinil were efficacious in reducing subjective sleepiness as measured by ESS [mean difference (95% confidence interval) at ≤ 4 weeks: -3.84 (-5.60, -2.07), -2.44 (-3.38, -1.49), and -2.41 (-3.60, -1.21) for solriamfetol, modafinil, and armodafinil, respectively; at > 4 weeks: -4.11 (-6.14, -2.08), -2.88 (-3.85, -1.91), -2.46 (-3.68, -1.24) for solriamfetol, armodafinil, and modafinil, respectively] and clinical global impression of change, as well as the objective MWT [at ≤ 4 weeks: 11.66 min (9.70, 13.61), 3.61 min (2.48, 4.73), and 2.52 min (1.27, 3.76) for solriamfetol, modafinil, and armodafinil, respectively; at > 4 weeks: 10.34 min (4.16, 16.52) for solriamfetol]. Pitolisant showed later improvements in ESS [at > 4 weeks: -2.70 (-3.66, -1.73)], with limited data on MWT. Sensitivity analyses restricted to U.S. Food and Drug Administration-approved solriamfetol dosages (37.5-150 mg/day) still showed higher efficacy, but lower anxiety risk.ConclusionsAmong all WPAs, solriamfetol demonstrated the highest efficacy on ESS and MWT, with the latter being significant. Modafinil demonstrated the best clinician impression, albeit not statistically significant. All four WPAs were associated with a low risk of serious or adverse events.RegistrationPROSPERO registration number, CRD42022359237.

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Modafinil is approved for excessive daytime sleepiness in narcolepsy, obstructive sleep apnoea (OSA), and shift work sleep disorder (SWSD), but its widespread off-label use raises safety concerns. We evaluated the risk of adverse events (AEs) associated with both labelled and off-label use of modafinil. A systematic search of PubMed, Embase, and Cochrane identified 54 studies that met the inclusion criteria. In labelled uses, narcolepsy patients had significantly elevated risks of diarrhoea (risk ratio [RR]: 2.16, 95% confidence interval [CI]: 1.06-4.41) and nausea compared to those with placebo (RR: 2.44, 95% CI: 1.05-5.72). OSA/hypopnea syndrome patients had higher risks of insomnia (RR: 5.82), anxiety/nervousness (RR: 3.26), and headache (RR: 1.92). SWSD patients had elevated risks of insomnia (RR: 4.09), anxiety/nervousness (RR: 3.85), and nausea (RR: 2.93). Among off-label users, patients with attention deficit hyperactivity disorder had higher risks of insomnia (RR: 4.97) and decreased appetite (RR: 4.21). Patients with major depressive disorder showed higher risks of anxiety/nervousness (RR: 1.95). While modafinil users share common AEs, specific risks vary across patient groups. Our findings on condition-specific AE profiles would support cautious prescribing of modafinil and careful consideration of alternative treatments.

Abstract licence: CC BY-NC

PurposeDuring pregnancy, it is unclear whether women with attention deficit hyperactivity disorder (ADHD) should stop prescribed medication - risking relapse - or continue - risking harm to themselves and their baby. We aimed to conduct a systematic review to examine whether ADHD medications should be continued during pregnancy.MethodsWe searched MEDLINE, Embase, PsycINFO, PubMed, CINAHL, AMED, CENTRAL, Cochrane Library, NHS Knowledge and Library Hub from 1st July 2019 to 1st July 2024, without any restrictions on language, setting, or study type. We supplemented this with relevant studies identified from the references of retrieved studies. Two authors used the Newcastle-Ottawa Scale (NOS) to independently rate the quality of included studies.ResultsTwelve cohort studies were included in the qualitative review. All were deemed high quality (NOS ≥ 7). Seven studies found ADHD medication use during pregnancy had no significant negative effect on maternal or offspring outcomes. One study found continuing ADHD medication reduced the risk of various negative outcomes, and another found stopping ADHD medication may increase the risk of threatened abortion. Three studies concluded that ADHD medication use was associated with negative outcomes: pre-eclampsia, gastroschisis, omphalocele, and transverse limb deficiency. Modafinil was identified as significantly increasing the risk of congenital malformations.ConclusionWomen taking modafinil should consider stopping it prior to pregnancy. Clinicians should discuss the risks, benefits, and uncertainties of other ADHD medications with women who are pregnant, or considering pregnancy, keeping in mind that the benefits of continuing ADHD medications- where it is effective for an individual- are likely to outweigh the risks.

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