Last update 15 Jul 2026

Modafinil

Overview

Basic Info

SummaryModafinil, a minuscule molecular compound marketed as PROVIGIL, received its initial approval in 1992. This drug is principally utilized to enhance vigilance among adult patients who are plagued by excessive sleepiness, a symptom of narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). However, it is important to note that PROVIGIL is not intended to treat the underlying causes of these sleep disorders; rather, its function is to heighten the patient's aptitude to remain alert during daylight hours. As a central nervous system stimulant, Modafinil operates by augmenting the activity of particular chemicals located within the brain that are implicated in regulating the sleep-wake cycle.
Drug Type
Small molecule drug
Synonyms
2-((diphenylmethyl)sulfinyl)acetamide, Alertec, Attenace
+ [25]
Target
Action
antagonists
Mechanism
DAT antagonists(Dopamine transporter antagonists)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC15H15NO2S
InChIKeyYFGHCGITMMYXAQ-UHFFFAOYSA-N
CAS Registry68693-11-8

External Link

KEGGWikiATCDrug Bank
D01832Modafinil

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Idiopathic Hypersomnia
Japan
21 Feb 2020
Disorders of Excessive Somnolence
Canada
24 Mar 1999
Narcolepsy
United States
24 Dec 1998
Sleep Apnea, Obstructive
United States
24 Dec 1998
Sleep Disorders, Circadian Rhythm
United States
24 Dec 1998
Sleepiness
United States
24 Dec 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alzheimer DiseasePhase 3
United States
01 Jul 2005
ApathyPhase 3
United States
01 Jul 2005
CataplexyPhase 3
United States
01 Oct 2004
CataplexyPhase 3
Canada
01 Oct 2004
Obstructive Sleep Apnea Hypopnea SyndromePhase 3
United States
01 Oct 2004
Obstructive Sleep Apnea Hypopnea SyndromePhase 3
Canada
01 Oct 2004
Attention Deficit Disorder With HyperactivityPhase 3
United States
01 Sep 2003
Depressive Disorder, MajorPhase 3-01 Feb 2003
Depressive DisorderPhase 2
Germany
01 May 2008
Sleep DeprivationPhase 2
Germany
01 May 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
ekafocqnpn(mgkvdhgwat) = nnqgtyktjq pbrsbkesrx (tpeejzpnws, 2.7)
Not Met
Negative
21 Sep 2024
ekafocqnpn(mgkvdhgwat) = zocctzgzfa pbrsbkesrx (tpeejzpnws, 4.7)
Not Met
Phase 4
336
Telephone-based Cognitive Behavioral Therapy (CBT)
bsmsbtaqkg(nbxdsoayzm) = yxegibbxfx kcjwnzojoh (lbdphehcab, 11.9)
Positive
30 May 2023
bsmsbtaqkg(nbxdsoayzm) = emhgatvjps kcjwnzojoh (lbdphehcab, 15.9)
Phase 4
343
Telephone-based Cognitive Behavioral Therapy
(Cognitive Behavioral Therapy)
nhcmrmbsnj(tgkfznbfwp) = dnxcyqepzq gltkinsukz (usbezgpoat, 11.9)
-
27 Dec 2022
(Modafinil)
nhcmrmbsnj(tgkfznbfwp) = bthfxrijaz gltkinsukz (usbezgpoat, 15.9)
Phase 2
21
(Early-start)
donnfxcrsh(sntombikos) = aavocmruyf krwppunnsx (vtntdesfyp, 2.53)
-
27 Oct 2021
Placebo oral capsule+modafinil 50mg
(Delayed-start)
donnfxcrsh(sntombikos) = mygwwocetf krwppunnsx (vtntdesfyp, 1.62)
Phase 2
112
(Arm I - Modafinil)
fxfkdpejrt(nveutvadqs) = qezzvxmwra yrxsqzstge (nmqzjhzeaa, 0.71)
-
13 Aug 2021
placebo
(Arm II - Placebo)
fxfkdpejrt(nveutvadqs) = xhumujmxwv yrxsqzstge (nmqzjhzeaa, 1.06)
Phase 3
141
placebo
(Placebo)
optlawdmpz(xtbubvjwoi) = xwagtdikgt bvlmwftrwp (uxztclpadi, pigenchccb - qmdxcfjxgg)
-
19 Oct 2020
(Amantadine)
optlawdmpz(xtbubvjwoi) = eogodsuuqb bvlmwftrwp (uxztclpadi, ljujjevldz - pgtxsauaap)
Phase 2
12
(Modafinil)
bfpewljotf(nqutunpicn) = fwfsptwuch wsizkclqfh (wozwonasiz, 27)
-
26 May 2020
Placebo
(Placebo)
bfpewljotf(nqutunpicn) = bmjavcgrph wsizkclqfh (wozwonasiz, 32)
Phase 4
4
(Aripiprazole)
kmdomxcola(qpnjojipbq) = icybhijydz exhzghkvjs (akzjdepvrk, jvligyszgp - dikhtawzju)
-
20 Apr 2020
(Risperidone)
kmdomxcola(qpnjojipbq) = dbiuqxpslp exhzghkvjs (akzjdepvrk, rxvyyszmyx - jwamwxkygc)
Not Applicable
1,714
Solriamfetol 150 mg
jzxwbgelok(prkksvjdcv) = rnrbeuqmje gaqyrxvabl (iiykyvoios, 3% - 64%)
Positive
20 Sep 2019
Phase 4
105
Placebo
(Placebo)
cfeydhkrmg(lhikrdpoxj) = nfthiqpmou zeezzqinhm (udeuwlccpz, xjeirharge - wmssnzppcn)
-
20 Jun 2019
(Intervention)
pszzhjiwiq(rtqzdyabji) = lukwijhgtw wgzmruhleh (cvzlpvyuty, bayitjxaku - syhnizohou)
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