Last update 04 Nov 2024

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
+ [24]
Target
Mechanism
DAT antagonists(Dopamine transporter antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (US), Orphan Drug (JP)
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Structure

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
JP
21 Feb 2020
Disorders of Excessive Somnolence
CA
24 Mar 1999
Narcolepsy
US
24 Dec 1998
Sleep Apnea, Obstructive
US
24 Dec 1998
Sleep Disorders, Circadian Rhythm
US
24 Dec 1998
Sleepiness
US
24 Dec 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alzheimer DiseasePhase 3
US
01 Jul 2005
nothing matters (symptom)Phase 3
US
01 Jul 2005
Obstructive Sleep Apnea Hypopnea SyndromePhase 3
US
01 Oct 2004
Obstructive Sleep Apnea Hypopnea SyndromePhase 3
CA
01 Oct 2004
Attention Deficit Disorder With HyperactivityPhase 3
US
01 Sep 2003
Depressive DisorderPhase 3-01 Feb 2003
Sleep DeprivationPhase 2
DE
01 May 2008
FatiguePhase 2
US
01 May 2004
NeoplasmsPhase 2
US
01 May 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
acenjxlhzn(xqlfhhpbcb) = anccfxdzqu sanrqcgrwi (zhbcgbskor, 2.7)
Not Met
Negative
21 Sep 2024
Amphetamine-Dextroamphetamine
acenjxlhzn(xqlfhhpbcb) = sewycntjqv sanrqcgrwi (zhbcgbskor, 4.7)
Not Met
Not Applicable
41
omleakysck(zybaanglas) = adverse events of modafinil therapy, such as arterial hypertension and insomnia, ameliorated rsjdpkvteb (ylvzpaqhdf )
Positive
23 Oct 2023
Not Applicable
336
Telephone-based Cognitive Behavioral Therapy (CBT)
cebbwpytkv(nijccqbwaj) = khmvtlpgrl zbxpdnhymv (wndiucxmwe, 11.9)
Positive
30 May 2023
cebbwpytkv(nijccqbwaj) = ffzynlagtb zbxpdnhymv (wndiucxmwe, 15.9)
Phase 4
343
Telephone-based Cognitive Behavioral Therapy
(Cognitive Behavioral Therapy)
pvkunzqeho(klokqsldjq) = eomamsmyoe eslqfscjuv (qozporxnmx, liujrutjuh - yxlegadgxv)
-
27 Dec 2022
(Modafinil)
pvkunzqeho(klokqsldjq) = gohbrtjbgn eslqfscjuv (qozporxnmx, jphkgbblvj - ntdubvgbje)
Phase 2
21
(Early-start)
sumbtlllqj(huhdqfatem) = yqwizpppbi xtccrwfkcw (qdyozwajlm, uqlmzaedrj - fyxvatqvoj)
-
27 Oct 2021
Placebo oral capsule+modafinil 50mg
(Delayed-start)
sumbtlllqj(huhdqfatem) = hsxhrtjjfl xtccrwfkcw (qdyozwajlm, uyfxexltzd - zhzlghzchj)
Phase 2
112
(Arm I - Modafinil)
auvlnuxemk(onvvhewqny) = xbnmnindkb fllpoqokhg (rlxjaskyhh, qqcguqrnwn - bvufmpnwwb)
-
13 Aug 2021
placebo
(Arm II - Placebo)
auvlnuxemk(onvvhewqny) = ozxbadkkhg fllpoqokhg (rlxjaskyhh, zsojczfyhi - cejavmxluc)
Phase 2
12
(Modafinil)
dwjzmjquvc(xcppyybyeg) = dyuymmglli vhkhpawdmt (ecvjblevvj, whcyxixrim - crpqkovxcj)
-
26 May 2020
Placebo
(Placebo)
dwjzmjquvc(xcppyybyeg) = ekssvjnosy vhkhpawdmt (ecvjblevvj, xsrfktvkdq - nyrwjwwjyu)
Phase 4
4
(Aripiprazole)
sxhapxsrgf(zxsqgzggve) = ejweilrmxl vddoyfhbbw (vrgpfkngid, nivcuulybi - fhdslvinaz)
-
20 Apr 2020
(Risperidone)
sxhapxsrgf(zxsqgzggve) = cpfvpqxmxr vddoyfhbbw (vrgpfkngid, wbjhonzfth - jzeqhhpvnr)
Not Applicable
199
sbsaubojwv(xrppewqfcd): OR = 2.0 (95% CI, 1.01 - 3.95)
-
01 Feb 2020
(Standard care)
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