Page last updated: 2024-10-31

modafinil and Sleep Disorders, Circadian Rhythm

modafinil has been researched along with Sleep Disorders, Circadian Rhythm in 36 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.

Sleep Disorders, Circadian Rhythm: Dyssomnias associated with disruption of the normal 24 hour sleep wake cycle secondary to travel (e.g., JET LAG SYNDROME), shift work, or other causes.

Research Excerpts

ExcerptRelevanceReference
"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)
"This 12-month, open-label, flexible-dose study with an extension period evaluated the tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy."9.14Tolerability and efficacy of armodafinil in naïve patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder, or narcolepsy: a 12-month, open-label, flexible-dose study with an extension period. ( Khan, A; McCall, WV; Schwartz, JR; Tiller, J; Weintraub, J, 2010)
"Patients with ES associated with treated OSA, SWD, or narcolepsy who completed one of four 12-week, double-blind studies were eligible for this multicenter, open-label study of > or = 12 months' duration of treatment with armodafinil (50 to 250 mg/day)."9.14The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study. ( Black, JE; Harsh, JR; Hull, SG; Tiller, J; Yang, R, 2010)
"This study indicates that modafinil is effective and well tolerated in the treatment of posttraumatic EDS but not of fatigue."9.14Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury. ( Bassetti, CL; Baumann, CR; Kaiser, PR; Meier, J; Stocker, R; Thomann, J; Valko, PO; Werth, E, 2010)
"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)
"This 12-month, open-label, flexible-dose study with an extension period evaluated the tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy."5.14Tolerability and efficacy of armodafinil in naïve patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder, or narcolepsy: a 12-month, open-label, flexible-dose study with an extension period. ( Khan, A; McCall, WV; Schwartz, JR; Tiller, J; Weintraub, J, 2010)
"Patients with ES associated with treated OSA, SWD, or narcolepsy who completed one of four 12-week, double-blind studies were eligible for this multicenter, open-label study of > or = 12 months' duration of treatment with armodafinil (50 to 250 mg/day)."5.14The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study. ( Black, JE; Harsh, JR; Hull, SG; Tiller, J; Yang, R, 2010)
"This study indicates that modafinil is effective and well tolerated in the treatment of posttraumatic EDS but not of fatigue."5.14Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury. ( Bassetti, CL; Baumann, CR; Kaiser, PR; Meier, J; Stocker, R; Thomann, J; Valko, PO; Werth, E, 2010)
"Armodafinil is a wake-promoting agent developed by Cephalon that was approved in mid-2007 for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder."4.84Armodafinil: a new treatment for excessive sleepiness. ( Lankford, DA, 2008)
" Pharmacokinetic studies suggest that armodafinil achieves higher plasma concentrations than modafinil late in a dose interval following equal oral doses."2.77Armodafinil and modafinil in patients with excessive sleepiness associated with shift work disorder: a pharmacokinetic/pharmacodynamic model for predicting and comparing their concentration-effect relationships. ( Bond, M; Darwish, M; Ezzet, F, 2012)
"Armodafinil was generally well tolerated."2.76Efficacy and tolerability of armodafinil: effect on clinical condition late in the shift and overall functioning of patients with excessive sleepiness associated with shift work disorder. ( Dammerman, R; Erman, MK; Seiden, DJ; Yang, R, 2011)
"Treatment with modafinil significantly attenuated the performance decrements seen for several parameters including cognitive-psychomotor speed, visual attention and reaction times both with progressive hours awake and when working at adverse circadian phases."2.75Effect of modafinil on impairments in neurobehavioral performance and learning associated with extended wakefulness and circadian misalignment. ( Aeschbach, D; Czeisler, CA; Grady, S; Wright, KP, 2010)
"Armodafinil was well tolerated and did not affect daytime sleep, as measured by polysomnography."2.74Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. ( Arora, S; Czeisler, CA; Roth, T; Walsh, JK; Wesnes, KA, 2009)
"Past modafinil use was reported by 2."2.74Modafinil and zolpidem use by emergency medicine residents. ( Ankel, FK; Asplin, BR; Flottemesch, TJ; Ling, LJ; Mason, EJ; McBeth, BD; McNamara, RM, 2009)
"Modafinil has recently been approved for the treatment of shift work sleep disorder, making it potentially available for shift-working emergency physicians."2.72Cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a double-blind randomized crossover study. ( Gill, M; Godenick, KL; Haerich, P; Tucker, JA; Westcott, K, 2006)
"Modafinil remained effective and well tolerated as an adjunct therapy for residual daytime sleepiness even after 12 weeks of daily dosing in patients with OSA receiving nCPAP therapy."2.71Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea: a 12-week, open-label study. ( Erman, MK; Hirshkowitz, M; Schmidt-Nowara, W; Schwartz, JR, 2003)
"Treatment with modafinil, as compared with placebo, resulted in a modest improvement from baseline in mean (+/-SEM) nighttime sleep latency (the interval between the time a person attempts to fall asleep and the onset of sleep) (1."2.71Modafinil for excessive sleepiness associated with shift-work sleep disorder. ( Arora, S; Czeisler, CA; Dinges, DF; Hughes, RJ; Kingsbury, L; Niebler, GE; Roth, T; Schwartz, JR; Walsh, JK; Wright, KP, 2005)
"Modafinil is a nonamphetamine nootropic drug with an increasingly therapeutic interest due to its different sites of action and behavioral effects in comparison to cocaine or amphetamine."2.66Pharmacokinetic and pharmacodynamic of the cognitive enhancer modafinil: Relevant clinical and forensic aspects. ( Dinis-Oliveira, RJ; Sousa, A, 2020)
"Modafinil probably has similar effects on sleepiness (KSS) (MD -0."2.50Pharmacological interventions for sleepiness and sleep disturbances caused by shift work. ( Costa, G; Driscoll, TR; Isotalo, LK; Liira, J; Ruotsalainen, JH; Sallinen, M; Verbeek, JH, 2014)
"Clinical trials in these sleep disorders demonstrated an enhanced efficacy for wake promotion (wake sustained for a longer time period using doses lower than those of modafinil)."2.44Armodafinil for excessive daytime sleepiness. ( Nishino, S; Okuro, M, 2008)
"Oral modafinil promotes wakefulness in patients with OSA/HS and SWSD."2.43Modafinil : a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder. ( Keating, GM; Raffin, MJ, 2005)
"Modafinil is a novel wakefulness-promoting agent that has been shown to improve cognitive performance and promote wakefulness among shift workers."1.33Modafinil, sleep deprivation, and cognitive function in military and medical settings. ( Westcott, KJ, 2005)

Research

Studies (36)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's19 (52.78)29.6817
2010's13 (36.11)24.3611
2020's4 (11.11)2.80

Authors

AuthorsStudies
Nicholson, PJ1
Savarese, M1
Di Perri, MC1
Sousa, A1
Dinis-Oliveira, RJ1
Sholtes, D1
Kravitz, HM1
Deka, A1
Westrick, J1
Fogg, LF1
Gottlieb, M1
Harsh, J1
Yang, R3
Hull, SG2
Liira, J1
Verbeek, JH1
Costa, G1
Driscoll, TR1
Sallinen, M1
Isotalo, LK1
Ruotsalainen, JH1
Mayer, G1
Benes, H1
Young, P1
Bitterlich, M1
Rodenbeck, A1
Drake, C1
Gumenyuk, V1
Roth, T4
Howard, R1
Burgess, HJ1
Reid, KJ1
Nishino, S1
Okuro, M1
Siegel, JM1
Russo, MB1
Stetz, MC1
Jenkins, CM1
Folen, RA1
Garnock-Jones, KP1
Dhillon, S1
Scott, LJ1
Rose, SH1
Curry, TB1
Czeisler, CA3
Walsh, JK3
Wesnes, KA1
Arora, S2
McBeth, BD1
McNamara, RM1
Ankel, FK1
Mason, EJ1
Ling, LJ1
Flottemesch, TJ1
Asplin, BR1
Thorpy, MJ1
Grady, S1
Aeschbach, D1
Wright, KP2
Schwartz, JR4
Khan, A1
McCall, WV1
Weintraub, J1
Tiller, J2
Black, JE1
Harsh, JR1
Kaiser, PR1
Valko, PO1
Werth, E1
Thomann, J1
Meier, J1
Stocker, R1
Bassetti, CL1
Baumann, CR1
Thorpy, M1
Darwish, M1
Bond, M1
Ezzet, F1
Erman, MK2
Seiden, DJ1
Dammerman, R1
Hirshkowitz, M1
Schmidt-Nowara, W1
Randazzo, AC1
Stone, KL1
Schweitzer, PK1
Westcott, KJ1
Hughes, RJ1
Kingsbury, L1
Niebler, GE1
Dinges, DF1
Basner, RC1
Keating, GM1
Raffin, MJ1
Hart, CL1
Haney, M1
Vosburg, SK1
Comer, SD1
Gunderson, E1
Foltin, RW1
Gill, M1
Haerich, P1
Westcott, K1
Godenick, KL1
Tucker, JA1
Neubauer, DN1
Lankford, DA1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder[NCT00080288]Phase 3254 participants (Actual)Interventional2004-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients [NCT01080807]Phase 4385 participants (Actual)Interventional2010-03-31Completed
Operational Evaluation of a Photic Countermeasure to Improve Alertness, Performance, and Mood During Nightshift Work on a 105-day Simulated Human Exploration Mission to Mars[NCT01169233]25 participants (Actual)Interventional2008-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Clinical Global Impression of Change (CGI-C)

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. (NCT00080288)
Timeframe: up to 12 weeks

InterventionParticipants (Number)
Armodafinil 150 mg/Day112
Placebo104

Multiple Sleep Latency Test (MSLT)

The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit). (NCT00080288)
Timeframe: up to 12 weeks

InterventionMinutes (Mean)
Armodafinil 150 mg/Day3.1
Placebo0.4

Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil9.4
Matching Placebo5.0

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score

FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.5

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.6

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.6
Matching Placebo0.5

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.6
Matching Placebo0.5

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score

FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15. (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil3.3
Matching Placebo2.6

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.5

Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.8
Matching Placebo-1.8

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-6.6
Matching Placebo-4.2

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.5

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.5
Matching Placebo-0.4

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.4
Matching Placebo-0.7

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation (or last observation after baseline))

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.5

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.2

Change From Baseline to Week 3 in Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and Week 3

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil6.9
Matching Placebo3.7

Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 3

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.6
Matching Placebo-1.6

Change From Baseline to Week 6 in Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and Week 6

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil9.8
Matching Placebo4.9

Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 6

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.9
Matching Placebo-1.8

Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint

The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil77
Matching Placebo57

Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3

The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home). (NCT01080807)
Timeframe: Baseline and week 3

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil78
Matching Placebo51

Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6

The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home). (NCT01080807)
Timeframe: Baseline and week 6

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil80
Matching Placebo56

Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil82.5
Matching Placebo80.7

Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil65.7
Matching Placebo46.1

Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil59.9
Matching Placebo44.1

Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil88.3
Matching Placebo96.3

Reviews

11 reviews available for modafinil and Sleep Disorders, Circadian Rhythm

ArticleYear
Excessive sleepiness in shift work disorder: a narrative review of the last 5 years.
    Sleep & breathing = Schlaf & Atmung, 2020, Volume: 24, Issue:1

    Topics: Adult; Circadian Rhythm; Disability Evaluation; Disorders of Excessive Somnolence; Female; Humans; M

2020
Pharmacokinetic and pharmacodynamic of the cognitive enhancer modafinil: Relevant clinical and forensic aspects.
    Substance abuse, 2020, Volume: 41, Issue:2

    Topics: Anxiety; Diarrhea; Drug Eruptions; Drug Interactions; Erythema Multiforme; Forensic Sciences; Headac

2020
Optimising sleep and performance during night float: A systematic review of evidence and implications for graduate medical education trainees.
    Journal of sleep research, 2021, Volume: 30, Issue:4

    Topics: Adaptation, Physiological; Attention; Caffeine; Education, Medical, Graduate; Energy Drinks; Fatigue

2021
Pharmacological interventions for sleepiness and sleep disturbances caused by shift work.
    The Cochrane database of systematic reviews, 2014, Aug-12, Issue:8

    Topics: Azabicyclo Compounds; Benzhydryl Compounds; Caffeine; Humans; Hypnotics and Sedatives; Melatonin; Mo

2014
Armodafinil for excessive daytime sleepiness.
    Drugs of today (Barcelona, Spain : 1998), 2008, Volume: 44, Issue:6

    Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Humans; Modafinil; Narcolepsy; Sle

2008
Armodafinil.
    CNS drugs, 2009, Volume: 23, Issue:9

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Clinical Trials as Topic; Humans; Modafinil

2009
Managing the patient with shift-work disorder.
    The Journal of family practice, 2010, Volume: 59, Issue:1 Suppl

    Topics: Benzhydryl Compounds; Combined Modality Therapy; Diet; Environment; Exercise; Female; Humans; Life S

2010
Understanding and diagnosing shift work disorder.
    Postgraduate medicine, 2011, Volume: 123, Issue:5

    Topics: Adult; Amphetamines; Benzhydryl Compounds; Central Nervous System Stimulants; Circadian Rhythm; Diag

2011
Modafinil : a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder.
    CNS drugs, 2005, Volume: 19, Issue:9

    Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence;

2005
Shift work sleep disorder: burden of illness and approaches to management.
    Drugs, 2006, Volume: 66, Issue:18

    Topics: Benzhydryl Compounds; Caffeine; Central Nervous System Stimulants; Circadian Rhythm; Cost of Illness

2006
Armodafinil: a new treatment for excessive sleepiness.
    Expert opinion on investigational drugs, 2008, Volume: 17, Issue:4

    Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Drug and Narcotic Control; Drugs,

2008

Trials

16 trials available for modafinil and Sleep Disorders, Circadian Rhythm

ArticleYear
The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder.
    Current medical research and opinion, 2014, Volume: 30, Issue:5

    Topics: Adult; Benzhydryl Compounds; Disorders of Excessive Somnolence; Double-Blind Method; Female; Humans;

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
Effects of armodafinil on simulated driving and alertness in shift work disorder.
    Sleep, 2014, Dec-01, Volume: 37, Issue:12

    Topics: Adult; Attention; Automobile Driving; Benzhydryl Compounds; Cognition; Creativity; Cross-Over Studie

2014
Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study.
    Mayo Clinic proceedings, 2009, Volume: 84, Issue:11

    Topics: Academic Medical Centers; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Diso

2009
Modafinil and zolpidem use by emergency medicine residents.
    Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2009, Volume: 16, Issue:12

    Topics: Adult; Akathisia, Drug-Induced; Amnesia; Anorexia; Benzhydryl Compounds; Central Nervous System Stim

2009
Effect of modafinil on impairments in neurobehavioral performance and learning associated with extended wakefulness and circadian misalignment.
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2010, Volume: 35, Issue:9

    Topics: Adult; Analysis of Variance; Benzhydryl Compounds; Body Temperature; Cognition Disorders; Double-Bli

2010
Tolerability and efficacy of armodafinil in naïve patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder, or narcolepsy: a 12-month, open-label, flexible-dose study with an extension period.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2010, Oct-15, Volume: 6, Issue:5

    Topics: Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Female; Follow-Up Studies; Hea

2010
The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2010, Oct-15, Volume: 6, Issue:5

    Topics: Adult; Benzhydryl Compounds; Blood Pressure; Central Nervous System Stimulants; Double-Blind Method;

2010
Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury.
    Neurology, 2010, Nov-16, Volume: 75, Issue:20

    Topics: Adult; Aged; Benzhydryl Compounds; Brain Injuries; Disorders of Excessive Somnolence; Double-Blind M

2010
Armodafinil and modafinil in patients with excessive sleepiness associated with shift work disorder: a pharmacokinetic/pharmacodynamic model for predicting and comparing their concentration-effect relationships.
    Journal of clinical pharmacology, 2012, Volume: 52, Issue:9

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Double-Blind Method; Humans; Modafinil; Mod

2012
Efficacy and tolerability of armodafinil: effect on clinical condition late in the shift and overall functioning of patients with excessive sleepiness associated with shift work disorder.
    Journal of occupational and environmental medicine, 2011, Volume: 53, Issue:12

    Topics: Adult; Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence; D

2011
Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea: a 12-week, open-label study.
    Chest, 2003, Volume: 124, Issue:6

    Topics: Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Chemotherapy, Adjuvant; Contin

2003
Modafinil improves alertness, vigilance, and executive function during simulated night shifts.
    Sleep, 2004, May-01, Volume: 27, Issue:3

    Topics: Adolescent; Adult; Aged; Arousal; Benzhydryl Compounds; Body Mass Index; Central Nervous System Stim

2004
Modafinil for excessive sleepiness associated with shift-work sleep disorder.
    The New England journal of medicine, 2005, Aug-04, Volume: 353, Issue:5

    Topics: Adult; Attention; Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive So

2005
Modafinil attenuates disruptions in cognitive performance during simulated night-shift work.
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2006, Volume: 31, Issue:7

    Topics: Affect; Analysis of Variance; Area Under Curve; Benzhydryl Compounds; Cognition Disorders; Dose-Resp

2006
Cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a double-blind randomized crossover study.
    Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2006, Volume: 13, Issue:2

    Topics: Adult; Attention; Benzhydryl Compounds; Central Nervous System Stimulants; Cognition; Double-Blind M

2006

Other Studies

9 other studies available for modafinil and Sleep Disorders, Circadian Rhythm

ArticleYear
Night work, sleepiness and modafinil.
    Occupational medicine (Oxford, England), 2021, 12-24, Volume: 71, Issue:9

    Topics: Benzhydryl Compounds; Disorders of Excessive Somnolence; Humans; Modafinil; Sleep Disorders, Circadi

2021
Keeping on the straight and narrow.
    Sleep, 2014, Dec-01, Volume: 37, Issue:12

    Topics: Attention; Automobile Driving; Benzhydryl Compounds; Female; Humans; Male; Modafinil; Motor Skills;

2014
Gaps that wake you up.
    Sleep, 2008, Volume: 31, Issue:12

    Topics: Animals; Arousal; Benzhydryl Compounds; Central Nervous System Stimulants; Evoked Potentials, Audito

2008
Armodafinil for the treatment of excessive sleepiness.
    Aviation, space, and environmental medicine, 2009, Volume: 80, Issue:8

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Dose-Response Relationship, Drug; Humans; J

2009
Fatigue, countermeasures, and performance enhancement in resident physicians.
    Mayo Clinic proceedings, 2009, Volume: 84, Issue:11

    Topics: Academic Medical Centers; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Fati

2009
Sleepiness versus sleeplessness: shift work and sleep disorders.
    The Journal of clinical psychiatry, 2004, Volume: 65, Issue:7

    Topics: Amphetamines; Benzhydryl Compounds; Central Nervous System Stimulants; Circadian Rhythm; Diagnosis,

2004
Modafinil, sleep deprivation, and cognitive function in military and medical settings.
    Military medicine, 2005, Volume: 170, Issue:4

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Cognition; Humans; Military Personnel; Moda

2005
Shift-work sleep disorder--the glass is more than half empty.
    The New England journal of medicine, 2005, Aug-04, Volume: 353, Issue:5

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence; Humans;

2005
Does modafinil safely and effectively treat shift-work sleep disorder?
    Nature clinical practice. Neurology, 2006, Volume: 2, Issue:3

    Topics: Adolescent; Adult; Arousal; Benzhydryl Compounds; Central Nervous System Stimulants; Double-Blind Me

2006