Page last updated: 2024-10-31

modafinil and Idiopathic Hypersomnia

modafinil has been researched along with Idiopathic Hypersomnia in 20 studies

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.

Idiopathic Hypersomnia: A sleep disorder of central nervous system origin characterized by prolonged nocturnal sleep and periods of daytime drowsiness. Affected individuals experience difficulty with awakening in the morning and may have associated sleep drunkenness, automatic behaviors, and memory disturbances. This condition differs from narcolepsy in that daytime sleep periods are longer, there is no association with CATAPLEXY, and the multiple sleep latency onset test does not record sleep-onset rapid eye movement sleep. (From Chokroverty, Sleep Disorders Medicine, 1994, pp319-20; Psychiatry Clin Neurosci 1998 Apr:52(2):125-129)

Research Excerpts

ExcerptRelevanceReference
"Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time."9.41Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study. ( Inoue, Y; Tabata, T; Tsukimori, N, 2021)
"In 2010 the European Medicines Agency withdrew the indication of modafinil for the treatment of obstructive sleep apnea, shift work sleep disorder and for idiopathic hypersomnia (IH)."9.20Modafinil in the treatment of idiopathic hypersomnia without long sleep time--a randomized, double-blind, placebo-controlled study. ( Benes, H; Bitterlich, M; Mayer, G; Rodenbeck, A; Young, P, 2015)
"We present the case of a 21-year-old woman in whom Stevens-Johnson syndrome (SJS) developed after initiation of armodafinil."7.88Stevens-Johnson Syndrome After Armodafinil Use. ( Holfinger, S; Roy, A; Schmidt, M, 2018)
"To evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs."7.77Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy. ( Arnulf, I; Dauvilliers, Y; Drouot, X; Franco, P; Golmard, JL; Lavault, S; Lecendreux, M; Leu-Semenescu, S, 2011)
"Modafinil is a well-tolerated psychostimulant drug with low addictive potential that is used to treat patients with narcolepsy and other excessive sleepiness."5.42Evaluation of the Effect of Modafinil on Cognitive Functions in Patients with Idiopathic Hypersomnia with P300. ( Aydin, T; Güzel, Hİ; Karakaya, F; Kayaalp, D; Mayda, H; Yaman, M, 2015)
"Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time."5.41Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study. ( Inoue, Y; Tabata, T; Tsukimori, N, 2021)
"In 2010 the European Medicines Agency withdrew the indication of modafinil for the treatment of obstructive sleep apnea, shift work sleep disorder and for idiopathic hypersomnia (IH)."5.20Modafinil in the treatment of idiopathic hypersomnia without long sleep time--a randomized, double-blind, placebo-controlled study. ( Benes, H; Bitterlich, M; Mayer, G; Rodenbeck, A; Young, P, 2015)
"Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia."5.19Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial. ( Capelli, A; Chaufton, C; Coste, O; Léger, D; Moore, N; Philip, P; Sagaspe, P; Taillard, J, 2014)
"We recommend that clinicians use modafinil for the treatment of narcolepsy in adults."5.12Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. ( Hashmi, SD; Kotagal, S; Maski, K; Robert Auger, R; Rowley, JA; Trotti, LM; Watson, NF, 2021)
" Two pharmaceutical company-sponsored trials compared modafinil with placebo, involving 102 participants, nearly all of whom had idiopathic hypersomnia without long sleep time."5.12Medications for daytime sleepiness in individuals with idiopathic hypersomnia. ( Becker, LA; Friederich Murray, C; Hoque, R; Trotti, LM, 2021)
"We present the case of a 21-year-old woman in whom Stevens-Johnson syndrome (SJS) developed after initiation of armodafinil."3.88Stevens-Johnson Syndrome After Armodafinil Use. ( Holfinger, S; Roy, A; Schmidt, M, 2018)
"To evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs."3.77Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy. ( Arnulf, I; Dauvilliers, Y; Drouot, X; Franco, P; Golmard, JL; Lavault, S; Lecendreux, M; Leu-Semenescu, S, 2011)
" Pharmacodynamic endpoints included the maintenance of wakefulness test (MWT), the Karolinska Sleepiness Scale (KSS), and the psychomotor vigilance task (PVT)."3.30Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia. ( Bogan, RK; Emsellem, H; Faessel, H; Foldvary-Schaefer, N; Mignot, E; Naylor, M; Neuwirth, R; Olsson, T; Swick, T, 2023)
"Modafinil, which was approved for idiopathic hypersomnia until 2011 in Europe, is the most commonly used treatment and improved sleepiness in two recent randomized placebo-controlled trials."3.01Update on the treatment of idiopathic hypersomnia: Progress, challenges, and expert opinion. ( Arnulf, I; Dauvilliers, Y; Roy, A; Thomas, R, 2023)
"Idiopathic hypersomnia (IH) includes a clinical phenotype resembling narcolepsy (with repeated, short restorative naps), and a phenotype with an excess of sleep, sleep drunkenness, drowsiness, and infrequent long, nonrestorative naps."2.82Precision Medicine for Idiopathic Hypersomnia. ( Arnulf, I; Dodet, P; Leu-Semenescu, S, 2022)
"Excessive daytime sleepiness (EDS) is related to medical and social problems, including mental disorders, physical diseases, poor quality of life, and so forth."2.66Pharmacologic Management of Excessive Daytime Sleepiness. ( Nishino, S; Takenoshita, S, 2020)
"Idiopathic hypersomnia is most often a chronic condition though spontaneous remission may occur."2.53Idiopathic hypersomnia. ( Billiard, M; Sonka, K, 2016)
"Central disorders of hypersomnolence include narcolepsy type 1, narcolepsy type 2, idiopathic hypersomnia and hypersomnia associated with medical or mental disorders."1.91[Potential teratogenicity of modafinil - Conflicting evidence, need for research]. ( Arnulf, I; Beghin, D; Coulm, B; Dauvilliers, Y; Elefant, E; Latour, M; Marin, B; Vauzelle, C, 2023)
"Modafinil was the most common drug used as a first-line treatment (93%) and in combination therapy (70%)."1.48Effectiveness and side-effect profile of stimulant therapy as monotherapy and in combination in the central hypersomnias in clinical practice. ( D'ancona, G; Drakatos, P; Kent, BD; Leschziner, GD; Nesbitt, A; Patel, K; Rosenzweig, I; Selsick, H; Steier, J; Thakrar, C; Williams, AJ, 2018)
"Modafinil is a well-tolerated psychostimulant drug with low addictive potential that is used to treat patients with narcolepsy and other excessive sleepiness."1.42Evaluation of the Effect of Modafinil on Cognitive Functions in Patients with Idiopathic Hypersomnia with P300. ( Aydin, T; Güzel, Hİ; Karakaya, F; Kayaalp, D; Mayda, H; Yaman, M, 2015)
"Methylphenidate was most commonly used as a first-line agent prior to December 1998, but subsequently, modafinil became the most common first drug."1.35Idiopathic hypersomnia: clinical features and response to treatment. ( Ali, M; Auger, RR; Morgenthaler, TI; Slocumb, NL, 2009)

Research

Studies (20)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (10.00)29.6817
2010's10 (50.00)24.3611
2020's8 (40.00)2.80

Authors

AuthorsStudies
Maski, K1
Trotti, LM2
Kotagal, S1
Robert Auger, R1
Rowley, JA1
Hashmi, SD1
Watson, NF1
Arnulf, I5
Leu-Semenescu, S3
Dodet, P2
Marin, B1
Latour, M1
Vauzelle, C1
Coulm, B1
Beghin, D1
Dauvilliers, Y5
Elefant, E1
Mignot, E1
Bogan, RK1
Emsellem, H1
Foldvary-Schaefer, N1
Naylor, M1
Neuwirth, R1
Faessel, H1
Swick, T1
Olsson, T1
Thomas, R1
Roy, A2
Takenoshita, S1
Nishino, S1
Inoue, Y1
Tabata, T1
Tsukimori, N1
Becker, LA1
Friederich Murray, C1
Hoque, R1
Thakrar, C1
Patel, K1
D'ancona, G1
Kent, BD1
Nesbitt, A1
Selsick, H1
Steier, J1
Rosenzweig, I1
Williams, AJ1
Leschziner, GD1
Drakatos, P1
Holfinger, S1
Schmidt, M1
Sagaspe, P2
Micoulaud-Franchi, JA1
Coste, O2
Léger, D2
Espié, S1
Davenne, D1
Lopez, R1
Philip, P2
Chaufton, C1
Taillard, J1
Capelli, A1
Moore, N1
Mayer, G1
Benes, H1
Young, P1
Bitterlich, M1
Rodenbeck, A1
Yaman, M1
Karakaya, F1
Aydin, T1
Mayda, H1
Güzel, Hİ1
Kayaalp, D1
Billiard, M1
Sonka, K1
Paquereau, J1
Bastuji, H1
Drouot, X2
Weil, JS1
Viot-Blanc, V1
Ali, M1
Auger, RR1
Slocumb, NL1
Morgenthaler, TI1
Lavault, S1
Golmard, JL1
Lecendreux, M1
Franco, P1
Quinnell, TG1
Smith, IE1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Clarithromycin for the Treatment of Hypersomnia[NCT01146600]Phase 226 participants (Actual)Interventional2010-07-31Completed
A Multi-Signal Based Monitoring System for CNS Hypersomnias : A 10-year Longitudinal Study[NCT05443373]600 participants (Anticipated)Observational2020-06-04Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Epworth Sleepiness Scale

"Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness." (NCT01146600)
Timeframe: baseline, then after 1 week and 2 weeks on each study drug

Interventionunits on a scale (Mean)
Clarithromycin10.1
Placebo14.1
Baseline15.0

FOSQ

"Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness." (NCT01146600)
Timeframe: baseline, then after 1 week and 2 weeks on each study drug

Interventionunits on a scale (Mean)
Clarithromycin16.6
Placebo14.4
Baseline13.9

PSQI

"Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality." (NCT01146600)
Timeframe: baseline, then after 1 week and 2 weeks on each study drug

Interventionunits on a scale (Mean)
Clarithromycin5.8
Placebo6.3
Baseline6.7

Psychomotor Vigilance Task (PVT) Reaction Time

"Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)" (NCT01146600)
Timeframe: week 2 of each intervention

InterventionMsec (Mean)
Clarithromycin279.1
Placebo311.6
Baseline333.8

PVT Median Reaction Time at Week 1

"median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)" (NCT01146600)
Timeframe: week 1

InterventionMsec (Mean)
Clarithromycin285.4
Placebo308.4
Baseline333.8

PVT Number of Lapses

Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance. (NCT01146600)
Timeframe: baseline, then after 1 week and 2 weeks on each study drug

InterventionNumber of lapses (Mean)
Clarithromycin5.7
Placebo10.3
Baseline6.5

SF-36, Vitality Subscale

"The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality." (NCT01146600)
Timeframe: baseline, then after 1 week and 2 weeks on each study drug

Interventionunits on a scale (Mean)
Clarithromycin48.9
Placebo28.0
Baseline25.0

Reviews

7 reviews available for modafinil and Idiopathic Hypersomnia

ArticleYear
Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2021, 09-01, Volume: 17, Issue:9

    Topics: Adult; Child; Disorders of Excessive Somnolence; Humans; Idiopathic Hypersomnia; Modafinil; Narcolep

2021
Precision Medicine for Idiopathic Hypersomnia.
    Sleep medicine clinics, 2022, Volume: 17, Issue:3

    Topics: Clarithromycin; Disorders of Excessive Somnolence; Female; Humans; Idiopathic Hypersomnia; Modafinil

2022
Update on the treatment of idiopathic hypersomnia: Progress, challenges, and expert opinion.
    Sleep medicine reviews, 2023, Volume: 69

    Topics: Disorders of Excessive Somnolence; Expert Testimony; Humans; Idiopathic Hypersomnia; Modafinil; Narc

2023
Pharmacologic Management of Excessive Daytime Sleepiness.
    Sleep medicine clinics, 2020, Volume: 15, Issue:2

    Topics: Central Nervous System Stimulants; Disorders of Excessive Somnolence; Humans; Idiopathic Hypersomnia

2020
Medications for daytime sleepiness in individuals with idiopathic hypersomnia.
    The Cochrane database of systematic reviews, 2021, 05-25, Volume: 5

    Topics: Bias; Clarithromycin; Disorders of Excessive Somnolence; Humans; Idiopathic Hypersomnia; Modafinil;

2021
Precision Medicine for Idiopathic Hypersomnia.
    Sleep medicine clinics, 2019, Volume: 14, Issue:3

    Topics: Central Nervous System Stimulants; Clarithromycin; Flumazenil; GABA Modulators; Humans; Idiopathic H

2019
Idiopathic hypersomnia.
    Sleep medicine reviews, 2016, Volume: 29

    Topics: Benzhydryl Compounds; Diagnosis, Differential; Humans; Idiopathic Hypersomnia; Modafinil; Narcolepsy

2016

Trials

5 trials available for modafinil and Idiopathic Hypersomnia

ArticleYear
Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia.
    Sleep, 2023, 09-08, Volume: 46, Issue:9

    Topics: Adult; Benzhydryl Compounds; Cross-Over Studies; Disorders of Excessive Somnolence; Humans; Idiopath

2023
Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study.
    Sleep medicine, 2021, Volume: 80

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence; Double-B

2021
Maintenance of Wakefulness Test, real and simulated driving in patients with narcolepsy/hypersomnia.
    Sleep medicine, 2019, Volume: 55

    Topics: Adult; Automobile Driving; Computer Simulation; Cross-Over Studies; Double-Blind Method; Humans; Idi

2019
Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.
    Sleep, 2014, Mar-01, Volume: 37, Issue:3

    Topics: Adolescent; Adult; Aged; Automobile Driving; Benzhydryl Compounds; Cross-Over Studies; Double-Blind

2014
Modafinil in the treatment of idiopathic hypersomnia without long sleep time--a randomized, double-blind, placebo-controlled study.
    Journal of sleep research, 2015, Volume: 24, Issue:1

    Topics: Adolescent; Adult; Benzhydryl Compounds; Double-Blind Method; Female; Humans; Idiopathic Hypersomnia

2015

Other Studies

8 other studies available for modafinil and Idiopathic Hypersomnia

ArticleYear
[Potential teratogenicity of modafinil - Conflicting evidence, need for research].
    Gynecologie, obstetrique, fertilite & senologie, 2023, Volume: 51, Issue:3

    Topics: Central Nervous System Stimulants; Disorders of Excessive Somnolence; Female; Humans; Idiopathic Hyp

2023
Effectiveness and side-effect profile of stimulant therapy as monotherapy and in combination in the central hypersomnias in clinical practice.
    Journal of sleep research, 2018, Volume: 27, Issue:4

    Topics: Adult; Central Nervous System Stimulants; Drug Therapy, Combination; Female; Follow-Up Studies; Head

2018
Stevens-Johnson Syndrome After Armodafinil Use.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2018, 05-15, Volume: 14, Issue:5

    Topics: Female; Humans; Idiopathic Hypersomnia; Modafinil; Skin; Stevens-Johnson Syndrome; Wakefulness-Promo

2018
Evaluation of the Effect of Modafinil on Cognitive Functions in Patients with Idiopathic Hypersomnia with P300.
    Medical science monitor : international medical journal of experimental and clinical research, 2015, Jun-27, Volume: 21

    Topics: Adolescent; Adult; Benzhydryl Compounds; Cognition; Event-Related Potentials, P300; Female; Humans;

2015
Psychological health in central hypersomnias: the French Harmony study.
    Journal of neurology, neurosurgery, and psychiatry, 2009, Volume: 80, Issue:6

    Topics: Adult; Antidepressive Agents; Benzhydryl Compounds; Cataplexy; Central Nervous System Stimulants; Co

2009
Idiopathic hypersomnia: clinical features and response to treatment.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2009, Dec-15, Volume: 5, Issue:6

    Topics: Actigraphy; Adult; Benzhydryl Compounds; Caffeine; Central Nervous System Stimulants; Dextroamphetam

2009
Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.
    Sleep medicine, 2011, Volume: 12, Issue:6

    Topics: Adult; Benzhydryl Compounds; Cataplexy; Central Nervous System Stimulants; Cohort Studies; Databases

2011
Narcolepsy, idiopathic hypersomnolence and related conditions.
    Clinical medicine (London, England), 2011, Volume: 11, Issue:3

    Topics: Antidepressive Agents, Tricyclic; Benzhydryl Compounds; Catalepsy; Central Nervous System Stimulants

2011