Modafinil 100mg/5ml oral solution

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.

Abstract licence: CC BY

BackgroundModafinil is a wakefulness-promoting agent widely used for narcolepsy and other sleep disorders. Although considered relatively safe, psychotic episodes associated with its use have been reported. However, no systematic review has focused on modafinil-associated psychosis.ObjectivesTo synthesize and describe the clinical characteristics, diagnostic backgrounds, and treatment outcomes of modafinil-associated psychosis through a systematic review of case reports and series.DesignSystematic review of published case reports and case series.Data sources and methodsA systematic literature search was conducted using PubMed and Web of Science. Case reports and series in English describing psychosis related to modafinil or armodafinil use were included. Age, sex, dose, diagnosis, symptoms, treatment, and outcomes were extracted and descriptively analyzed.ResultsTwenty-four patients (13 men and 11 women, mean age 37.4 years) from 21 articles were included. The most common symptoms were hallucinations (66.7%) and delusions (58.3%). Median modafinil dose was 250 mg/day; however, some patients received excessive doses. The diagnoses included narcolepsy (33.3%), schizophrenia (20.8%), and depression (20.8%). Eighteen patients (75.0%) were treated with antipsychotics, and 16 (66.7%) discontinued modafinil. Most patients (70.8%) showed marked improvement.ConclusionModafinil-associated psychosis can develop across wide diagnostic and age ranges, and sometimes even at therapeutic doses. Although the potential risk factors remain unclear, caution should be exercised regarding the drug's use at high doses, in patients with comorbid psychiatric conditions, and in cases of off-label usage for cognitive enhancement. Long-term follow-up is necessary to monitor outcomes and transition to schizophrenia. Further research is needed to identify the predictive factors and elucidate the underlying neurobiological mechanisms.Trial registrationNot registered.

Abstract licence: CC BY-NC