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A position that adrafinil is an unapproved drug was indicated in a warning letter [1] by the FDA in 2019: “Your [particular] products [subject to this warning] [including] Adrafinil…are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are 'new drugs' under section 201(p) of the Act.
Besides their potential medical use, modafinil analogues, including adrafinil, flmodafinil, fladrafinil, and modafiendz, are also sold online as substances that are believed to improve cognitive functions such as memory and focus (nootropics or "cognitive enhancers"). [1] [9] [10] [11]
Chemically, fladrafinil is a derivative of adrafinil (N-hydroxymodafinil) and is also known as bisfluoroadrafinil (it is the bis(4-fluoro) phenyl ring-substituted derivative of adrafinil). [1] It is closely related to flmodafinil (CRL-40,940; bisfluoromodafinil).
The wakefulness-promoting agent modafinil and its analogues (e.g., adrafinil, armodafinil) have been approved to treat narcolepsy and shift work sleep disorder. [6] These act as weak DRIs, [7] but this effect does not correlate with wakefulness-promoting effects, suggesting the effect is too weak to be of clinical significance.
Modafinil, sold under the brand name Provigil among others, is a central nervous system (CNS) stimulant and eugeroic (wakefulness promoter) medication used primarily to treat narcolepsy, [3] [8] [15] a sleep disorder characterized by excessive daytime sleepiness and sudden sleep attacks. [16]
Adrafinil acts as a prodrug of modafinil and hence shares its mechanism of action. [13] Certain other drugs acting as atypical DRIs with known or potential wakefulness-promoting effects include solriamfetol (also a norepinephrine reuptake inhibitor ), [ 14 ] [ 15 ] vanoxerine , [ 16 ] phenylpiracetam , [ 17 ] [ 18 ] [ 19 ] and mesocarb .
Armodafinil, sold under the brand name Nuvigil, is a wakefulness-promoting medication which is used to treat excessive daytime sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work disorder. [1]
Modafinil acid is also a metabolite of the modafinil prodrug, adrafinil, and the (R)-(–)-enantiomer is a metabolite of armodafinil, the (R)-(–)-enantiomer of modafinil. [2] Between 30 - 60% of modafinil is converted to modafinil acid and its half life is roughly half that of modafinil (about 7 hours). [3]