We use essential cookies (authentication, your saved goals/stack) by default. With your permission we'll also enable privacy-respecting analytics (Vercel Web Analytics, anonymous load-time metrics) and error-replay diagnostics (Sentry — DOM snapshots only when an error fires) so we can fix bugs faster. Learn more about cookies
Arm5.0
Armodafinil (Nuvigil) Research
Mostly mechanism / observationalLimited safety
8 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Armodafinil (Nuvigil) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 2006–2020 with a typical study size of 254 participants.
Based on 8 studies · 1 meta-analysis · 4 RCTs · 883 total participants
Confidence
Moderate
By outcome
Wakefulness & sleep/wake disorders
Mostly mechanism / observational5 studies
Cognition & off-label use
Mostly mechanism / observational3 studies
Safety profile
Too few graded studies1 study
Older research base
Newest study from 2020 · Latest meta-analysis: 2017
200620132020
1RCTn=196 · medium study2006
Armodafinil significantly increased MWT mean sleep latency compared with placebo and improved the Clinical Global Impression of Change in patients with excessive sleepiness associated with narcolepsy.
Harsh, Hayduk, Rosenberg, Wesnes, Walsh, Arora · Current medical research and opinion (2006)
Pivotal 12-week, multicenter, double-blind, placebo-controlled RCT in 196 narcolepsy patients (armodafinil 150 mg, 250 mg, or placebo once daily)
Significantly increased Maintenance of Wakefulness Test sleep latency, including late-day (1500–1900) latency, versus placebo (p < 0.01)
Improved the Clinical Global Impression of Change and subjective (Epworth) sleepiness
Armodafinil 150 or 250 mg QD significantly improved wakefulness and clinical condition as adjunctive treatment for residual excessive sleepiness associated with OSA/HS in patients adherent to nCPAP.
12-week, 37-center, double-blind, placebo-controlled RCT of armodafinil 150 or 250 mg as adjunct in nCPAP-adherent OSA/hypopnea patients with residual excessive sleepiness
Significantly improved objective wakefulness (Maintenance of Wakefulness Test) and Clinical Global Impression of Change versus placebo
Reduced subjective (Epworth) sleepiness without compromising adherence to nCPAP
Armodafinil, 150 mg, significantly improved physiologic sleep propensity, clinician-rated condition, and cognitive performance during night-shift hours in patients with shift work disorder.
Czeisler, Walsh, Wesnes, Arora, Roth · Mayo Clinic proceedings (2009)
12-week, 42-site, randomized, double-blind, placebo-controlled RCT in 254 night-shift workers with moderate-or-greater shift work disorder (armodafinil 150 mg vs placebo before each shift)
Improved physiologic sleep propensity during night-shift hours and Clinical Global Impression of severity versus placebo
Improved patient-reported sleepiness and cognitive performance across the night shift
Adjunctive armodafinil 150 mg significantly improved symptoms of major depressive episodes associated with bipolar I disorder versus placebo (Cohen d therapeutic effect size = 0.28) and was generally well tolerated.
Calabrese, Frye, Yang, Ketter, Armodafinil Treatment Trial Study Network · The Journal of clinical psychiatry (2014)
Randomized, double-blind, placebo-controlled multicenter trial of adjunctive armodafinil 150 mg in 433 adults with bipolar I depression
Significantly greater decrease in IDS-C30 depressive-symptom score at week 8, but the effect was MODEST (Cohen d ≈ 0.28)
Response rate higher than placebo (46% vs 34%); remission rate did not differ significantly
Psychostimulants are insufficiently studied as adjunctive or monotherapy in adults with mood disorders; most published studies have significant methodological limitations.
A review of modafinil (and of its prodrug adrafinil and its enantiomer armodafinil) pharmacokinetics, pharmacodynamics and clinical and forensic aspects.
Sousa, Dinis-Oliveira · Substance abuse (2020)
Pharmacokinetic/pharmacodynamic review that frames adrafinil explicitly as the prodrug of modafinil
Wakefulness is driven by the modafinil metabolite acting on catecholamine, orexin, and histamine arousal systems
Covers the clinical and forensic (doping) context in which adrafinil is now mostly encountered
Wakefulness-promoting agents including armodafinil are available to treat the excessive sleepiness associated with sleep/wake disorders such as narcolepsy, shift work disorder, and treated obstructive sleep apnea.
Schwartz, Roth, Drake · Neuropsychiatric disease and treatment (2010)
Clinical review of armodafinil across its approved sleep/wake indications (narcolepsy, shift-work disorder, residual sleepiness in treated OSA)
Summarizes the pivotal RCT evidence and the once-daily, longer-acting R-enantiomer rationale
Frames identification and treatment of excessive sleepiness as a public-health priority
We present the case of a 21-year-old woman in whom Stevens-Johnson syndrome developed after initiation of armodafinil; this case and a post-marketing label update support the link between armodafinil and SJS.
Holfinger, Roy, Schmidt · Journal of clinical sleep medicine (2018)
Case report of Stevens-Johnson syndrome developing after initiation of armodafinil in a 21-year-old woman
First literature-reported SJS case for armodafinil, corroborating the label's serious skin-reaction warning
Authors advise high clinical suspicion and immediate discontinuation at the first symptoms