armodafinil / Generic mfg. - LARVOL DELTA

A Case Report: Lisdexamfetamine-Induced Delusional Parasitosis. (PubMed, Cureus) - "Although stimulant treatment with methylphenidate or mixed amphetamine salts has been associated with delusional parasitosis, there is yet a case in the literature illustrating delusional infestation secondary to lisdexamfetamine. The following case is unique in that lisdexamfetamine caused delusional parasitosis in a 53-year-old man with ADHD who previously tolerated mixed amphetamine salts and armodafinil without side effects. The discontinuation of lisdexamfetamine, coupled with a second-generation antipsychotic, quickly resolved the delusion. For those who may prescribe lisdexamfetamine or treat patients with ADHD, it is crucial to carefully assess medication use, as discontinuation or dose adjustment of the suspected causative drug can have a positive impact on the course of delusional parasitosis."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Dermatology • Psychiatry • Restless Legs Syndrome

Comparative Efficacy and Safety of Multiple Wake-Promoting Agents for the Treatment of Residual Sleepiness in Obstructive Sleep Apnea Despite Continuous Positive Airway Pressure: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, CNS Drugs) - "Among 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."

Journal • Retrospective data • Review • CNS Disorders • Depression • Mood Disorders • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Disorder

RARE PRESENTATION OF ARMODAFINIL-INDUCED CARDIOMYOPATHY COMPLICATED BY VENTRICULAR FIBRILLATION ARREST - Praveen Prabhu (ACC 2025) - "Clinicians should conduct a thorough cardiovascular (CV) evaluation before prescribing armodafinil to decrease the risk of developing ventricular arrhythmias or cardiomyopathy. In this patient, alternative therapies may have been utilized if LVH was seen on an echocardiogram. Thorough medication reconciliation is prudent, and stimulants must be immediately discontinued as this has led to remission of arrhythmias in prior documented cases."

Cardiomyopathy • Cardiovascular • Coronary Artery Disease • Heart Failure • Hypertension • Myocardial Infarction • Obstructive Sleep Apnea • Pulmonary Embolism • Respiratory Diseases • Sleep Disorder

Management options for excessive daytime sleepiness in patients with obstructive sleep apnea. (PubMed, Expert Rev Respir Med) - "Solriamfetol and pitolisant are wake-promoting agents (WPA) recently approved for use in sleepy OSA patients accepting or refusing OSA treatment...However, it is still uncertain which subgroups of patients should be treated for the symptom of EDS while maintaining a low-risk profile in terms of consequences of OSA on health. Until such data are available, use of WPA in OSA patients should be managed by Sleep Specialists."

Journal • Review • Cardiovascular • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial (AAN 2025) - "Stable concurrent modafinil/armodafinil use was allowed. AXS-12 met its primary endpoint, leading to a substantial, statistically significant reduction in weekly cataplexy attacks. Improvements in EDS and cognition were also observed, suggesting AXS-12 may offer effective treatment for multiple narcolepsy symptoms with a favorable safety profile."

P3 data • P3 data: top line • Alzheimer's Disease • Cataplexy • Cognitive Disorders • Constipation • Excessive Daytime Sleepiness • Gastroenterology • Gastrointestinal Disorder • Narcolepsy • Sleep Disorder • Xerostomia

Apotex acquires US rights to PROVIGIL (modafinil) and NUVIGIL (armodafinil) (Canada Newswire) - "Apotex Inc...today announced that its affiliate Nuvo Pharmaceuticals (Ireland) DAC has acquired the United States rights to PROVIGIL (modafinil) and NUVIGIL (armodafinil)...PROVIGIL and NUVIGIL each improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work sleep disorder, and are prescribed by psychiatrists, endocrinologists, internists, sleep specialists, and primary care physicians."

Commercial • CNS Disorders • Narcolepsy • Sleep Disorder

Armodafinil as Monotherapy in Treating Narcolepsy with Cataplexy. (PubMed, Cureus) - "In narcolepsy with cataplexy, sodium oxybate and the recently FDA-approved drug pitolisant are preferred medications. Armodafinil, a longer-acting, non-amphetamine stimulant, is often used in patients who have narcolepsy without cataplexy...It is known that sodium oxybate, through its gamma-aminobutyric acid type B (GABA-B) receptor agonist activity, helps in cataplexy and EDS. However, in some instances, like this patient, armodafinil alone improves the symptoms of cataplexy and maintains wakefulness."

Journal • Monotherapy • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Serotonin Norepinephrine Reuptake Inhibitor is Associated with Lower Mortality Among Patients Presenting with Takotsubo Cardiomyopathy (AHA 2024) - "Patients with a history of myocarditis, pheochromocytoma, acute myocardial infarction, cocaine-related disorders, opioid-related disorders, and patients on with an active prescription for 5-fluorouracil, capecitabine, gemcitabine, and trastuzumab were excluded. Additionally, patients on selective serotonin reuptake inhibitors, tricyclic antidepressants, modafinil, armodafinil, methylphenidate, bupropion and atomoxetine were excluded...The final study population was divided into two cohorts: Patients on SNRIs (duloxetine, venlafaxine, and desvenlafaxine) and patients not on SNRIs... The use of SNRIs among patients presenting with takotsubo cardiomyopathy is associated with lower mortality and lower takotsubo cardiomyopathy-related complications."

Clinical • Addiction (Opioid and Alcohol) • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • CNS Disorders • Depression • Endocrine Cancer • Inflammation • Myocardial Infarction • Neuralgia • Oncology • Pain • Psychiatry • Solid Tumor

Comparative efficacy, safety and benefit/risk of alerting agents for excessive daytime sleepiness in patients with obstructive sleep apnoea: a network meta-analysis. (PubMed, EClinicalMedicine) - "The aim of this study is to compare the relative efficacy and safety of medications authorised for this indication in Europe and/or the United States (modafinil/armodafinil, solriamfetol, and pitolisant) for OSA. The overall and cardiovascular safety risk ratios suggest that pitolisant might be the best candidate for patients with OSA with multiple cardiovascular comorbidities. Bioprojet."

Benefit-risk assessment • Journal • Retrospective data • Cardiovascular • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Excessive daytime sleepiness in obstructive sleep apnea: Indirect treatment comparison of wake-promoting agents in patients adherent/nonadherent to primary OSA therapy. (PubMed, Sleep Med Rev) - "This network meta-analysis evaluated the efficacy and safety of wake-promoting agents (WPAs), namely solriamfetol, pitolisant, modafinil, and armodafinil, for treating residual EDS in patients with OSA. Our analysis comprehensively compared the effects and adverse reactions of different WPAs in treating residual EDS in treated patients with OSA. This has significant implications for the practical clinical use of WPAs and future research."

Journal • Review • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Efficacy and Safety of Modafinil/Armodafinil for Post-Traumatic Hypersomnia: A Systematic Review and Meta-analysis (EAN 2024) - "Treatment with modafinil or armodafinil was associated with a significant reduction in somnolence in post-TBI patients when compared to placebo. However, this therapy also increased the risk of insomnia. Further research is warranted to optimize the risk-benefit profile of these agents in this population."

Retrospective data • Review • CNS Disorders • Excessive Daytime Sleepiness • Infectious Disease • Insomnia • Pain • Sleep Disorder • Vascular Neurology

EEG evaluation of the influence of rTMS in the rehabilitation of patients with ischemic stroke. (EAN 2024) - " The main trend of influence of rTMS on the brain activity is associated with a clear increase in the share of alpha rhythm, especially FIGURE 1 In patients with post-traumatic hypersomnia, somnolence, as measured by the Epworth Sleepiness Scale, was significantly reduced in the modafinil/armodafinil when compared to placebo... rTMS appears to be a promising therapeutic method to improve functional recovery in patients with ischemic stroke. The routine use of EEG is an invaluable technique for monitoring and optimizing the individual effect of each patient during the course of treatment."

Clinical • Cardiovascular • Ischemic stroke • Sleep Disorder

Evaluating pharmacological treatments for excessive daytime sleepiness in obstructive sleep apnea: A comprehensive network meta-analysis and systematic review. (PubMed, Sleep Med Rev) - "Solriamfetol, followed by Pitolisant and modafinil, exhibited the greatest ESS reduction, while Danavorexton, followed by Solriamfetol and MK-7288, had the strongest impact on MWT. MK-7288 had the most total adverse events (AEs), followed by Danavorexton and armodafinil. Pharmacological Interventions significantly alleviate EDS in OSA patients but with heterogeneity across medications. Treatment decisions should involve a personalized assessment of patient factors and desired outcomes."

Journal • Retrospective data • Review • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Modafinil / Armodafinil in Bipolar Disorder: Lesson Learned, Roadmap Forward (ASCP 2024) - "bimodal mood stabilization quetiapine, cariprazine), were co-prescribed with an antimanic agent (i.e. olanzapine fluoxetine combination), or generally assumed to have antimanic properties as a class effect in bipolar disorder (i.e. lurasidone, lumataperone). Better understand design challenges in a non-mood stabilizer being investigated for bipolar depression 2. Appreciate subtypes of bipolar depression that may prove useful for subsequent narrower investigation Literature"

Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Revisiting Modafinil / Armodafinil in Bipolar Disorder Targeting Cognition, Depression, and Sleep Circadian Rhythm (ASCP 2024) - "To review the methodological limitations of developing modafinil / armodafinil for bipolar depression 2. Better understand cognitive impairment and sleep circadian rhythm in bipolar disorder and as a target for modafinil / armodafinil Literary"

Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Narcolepsy • Obstructive Sleep Apnea • Psychiatry • Sleep Disorder

Effectiveness of biomedical interventions on the chronic stage of traumatic brain injury: a systematic review of randomized controlled trials. (PubMed, Front Neurol) - "Our search results indicate that despite the largest volume of literature, pharmacological interventions, especially using neurostimulant medications to treat physical, cognitive, and mental fatigue, as well as daytime sleepiness, have yielded inconsistent results, such that some studies found improvements in fatigue (e.g., Modafinil, Armodafinil) while others failed to yield the improvements after the intervention. Conversely, brain stimulation techniques (e.g., transcranial magnetic stimulation, blue light therapy) and exercise interventions were effective in ameliorating mental health symptoms and cognition. However, given that most RCTs are equipped with small sample sizes, more high-quality, larger-scale RCTs is needed."

Review • Alzheimer's Disease • CNS Disorders • Fatigue • Sleep Disorder • Vascular Neurology

Armodafinil as a Potential Pharmacological Treatment for Attention Deficit Hyperactivity Disorder in Adults: A Review. (PubMed, Curr Neuropharmacol) - "Armodafinil could be useful for the treatment of ADHD in adults, according to the review of the literature from both pre-clinical and clinical studies."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Fatigue • Psychiatry • Sleep Disorder

A Review of Current and Future Pharmacologic Treatments for Narcolepsy (EPA 2024) - " Treatment historically has included medications developed for the treatment of other conditions such as psychostimulants (methylphenidate, modafinil/armodafinil, pemoline) and antidepressants (SSRIs,TCAs)...Pitolisant, a histamine H3 receptor inverse agonist, is approved for the treatment of EDS or cataplexy in adult patients with narcolepsy (and children> 6 years in European Union) (Keam SJ.Paediatr Drugs...Solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI) is indicated to improve wakefulness in adult patients with EDS associated with narcolepsy or obstructive sleep apnea (OSA) (Winter Y, et al... Despite limited understanding of the pathophysiology of narcolepsy there have been substantial advances in the pharmacotherapy, including medications now approved for children. Early diagnosis and treatment are associated with better outcomes. In view of the chronic and disabling morbidity associated with narcolepsy further research and better access to..."

Review • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Obstructive Sleep Apnea • Sleep Disorder

Drug repurposing as add-on treatment strategy for mania and bipolar depression: systematic synthesis and qualitative appraisal of the existing meta-analytic evidence (EPA 2024) - "In bipolar depression, modafinil/armodafinil (for response, remission, and symptoms reduction at 6-8 weeks) and pramipexole (for response and symptoms reductionat 6 weeks) were superior to placebo, with low-quality evidence. Results on celecoxib and N-acetylcysteine were of low quality and limited to certain outcomes. Overall, the lack of evidence of high and moderate quality does not allow firm conclusions on the clinical utility of repurposed drugs as adjunctive treatments for mania and bipolar depression, limiting recommendations for their use in clinical practice. However, since some lines of evidence seem to hold some potential, and standard treatments for mania and bipolar depression remain not entirely satisfactory, the search for novel therapeutic targets and strategies for the management of BD warrants further research in the field."

Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and safety of established and off-label ADHD drug therapies for cognitive impairment or attention-deficit hyperactivity disorder symptoms in bipolar disorder: A systematic review by the ISBD Targeting Cognition Task Force. (PubMed, Bipolar Disord) - "Methylphenidate or mixed amphetamine salts may improve ADHD symptoms in BD. However, there is limited evidence regarding the effectiveness on cognition. The medications produced no increased mania risk when used alongside mood stabilizers. Further robust studies are needed to assess cognition in BD patients receiving psychostimulant treatment alongside mood stabilizers."

Journal • Review • ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry

Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: M.D. Anderson Cancer Center | Phase classification: P2 ➔ P1/2

Phase classification • Fatigue • Head and Neck Cancer • Oncology • Solid Tumor

The Nuvigil and Provigil Pregnancy Registry (clinicaltrials.gov) - P=N/A | N=191 | Terminated | Sponsor: Cephalon, Inc. | N=300 ➔ 191 | Trial completion date: Jan 2027 ➔ Nov 2023 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2027 ➔ Nov 2023; The study is no longer feasible.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Narcolepsy • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Insights into the management of Lewy body dementia: a scoping review. (PubMed, Ann Med Surg (Lond)) - "Donepezil, rivastigmine, memantine, and galantamine were the commonly used drugs for LBD. Together with that, levodopa, antipsychotics, armodafinil, piracetam, and traditional medications like yokukansan were also used, when indicated...Talking about recent advances in the treatment of LBD, various disease-modifying therapies like ambroxol, neflamapimod, irsenontrine, nilotinib, bosutinib, vodobatinib, clenbuterol, terazosin, elayta, fosgonimeton, and anle138b are emerging out...With the different pharmacological and nonpharmacological modalities we have for treatment of LBD, all of them offer symptomatic relief only. Being a degenerative disease, definite cure of the disease can only be possible with regenerative measures."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease

COMPARATIVE ANALYSIS OF EFFECTIVENESS OF OBESITY TREATMENT IN PRIMARY CARE USING PATIENT-ORIENTED APPROACH WITH MOTIVATIONAL COUNSELING FOR LIFESTYLE CORRECTION AND ITS COMBINATION WITH ARMODAFINIL THERAPY IN PATIENTS WITH CONCOMITANT SHIFT WORK SLEEP DISORDER. (PubMed, Pol Merkur Lekarski) - " The use of armofafinil in addition to patientoriented motivational counseling in lifestyle correction ("5 As" and "5R") in patients with obesity connected with shift work disorder and excessive daytime sleepiness allows to reduce body weight by more than 16,52%, in contrast to isolated use of the same technique of motivational counseling in obese patients without sleep disorder (only 5,51%)."

Journal • CNS Disorders • Depression • Diabetes • Excessive Daytime Sleepiness • Genetic Disorders • Metabolic Disorders • Mood Disorders • Obesity • Psychiatry • Sleep Disorder • LEP

NARCOLEPSY WITH CATAPLEXY PRESENTING AS LONGSTANDING SEIZURES (CHEST 2023) - "This case details a patient presenting with recurrent seizures since childhood who, at the age of 58, had resolution of "seizures" with diagnosis and treatment for narcolepsy type I. CASE PRESENTATION: A 59-year-old female presented to her cardiologist for supraventricular tachycardia and autonomic dysfunction treated with propranolol and midodrine with complaints of persistent syncope...She was diagnosed with narcolepsy with cataplexy and subsequently started on sodium oxybate and armodafinil with complete resolution of her cataplexy... This 59-year-old female presented with recurrent syncope in the setting of SVT and hypotension. The patient endorsed a history of chronic hypersomnolence, and her astute physician referred the patient to sleep medicine for further evaluation. Her childhood seizure disorder turned out to be a classic tale of narcolepsy with cataplexy, undiagnosed and untreated for 58 years."

Atrial Fibrillation • Cardiovascular • Cataplexy • CNS Disorders • Epilepsy • Excessive Daytime Sleepiness • Hypotension • Narcolepsy • Obstructive Sleep Apnea • Rare Diseases • Respiratory Diseases • Sleep Disorder • Ventricular Tachycardia