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.
Excerpt | Relevance | Reference |
---|---|---|
"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)." | 9.20 | Modafinil 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." | 9.14 | 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. ( 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)." | 9.14 | 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. ( 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." | 9.14 | Modafinil 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)." | 5.20 | Modafinil 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." | 5.14 | 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. ( 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)." | 5.14 | 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. ( 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." | 5.14 | Modafinil 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." | 4.84 | Armodafinil: 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." | 2.77 | 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. ( Bond, M; Darwish, M; Ezzet, F, 2012) |
"Armodafinil was generally well tolerated." | 2.76 | 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. ( 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." | 2.75 | Effect 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." | 2.74 | Armodafinil 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." | 2.74 | Modafinil 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." | 2.72 | Cognitive 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." | 2.71 | Modafinil 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." | 2.71 | Modafinil 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." | 2.66 | Pharmacokinetic 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." | 2.50 | Pharmacological 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)." | 2.44 | Armodafinil for excessive daytime sleepiness. ( Nishino, S; Okuro, M, 2008) |
"Oral modafinil promotes wakefulness in patients with OSA/HS and SWSD." | 2.43 | Modafinil : 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." | 1.33 | Modafinil, sleep deprivation, and cognitive function in military and medical settings. ( Westcott, KJ, 2005) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 19 (52.78) | 29.6817 |
2010's | 13 (36.11) | 24.3611 |
2020's | 4 (11.11) | 2.80 |
Authors | Studies |
---|---|
Nicholson, PJ | 1 |
Savarese, M | 1 |
Di Perri, MC | 1 |
Sousa, A | 1 |
Dinis-Oliveira, RJ | 1 |
Sholtes, D | 1 |
Kravitz, HM | 1 |
Deka, A | 1 |
Westrick, J | 1 |
Fogg, LF | 1 |
Gottlieb, M | 1 |
Harsh, J | 1 |
Yang, R | 3 |
Hull, SG | 2 |
Liira, J | 1 |
Verbeek, JH | 1 |
Costa, G | 1 |
Driscoll, TR | 1 |
Sallinen, M | 1 |
Isotalo, LK | 1 |
Ruotsalainen, JH | 1 |
Mayer, G | 1 |
Benes, H | 1 |
Young, P | 1 |
Bitterlich, M | 1 |
Rodenbeck, A | 1 |
Drake, C | 1 |
Gumenyuk, V | 1 |
Roth, T | 4 |
Howard, R | 1 |
Burgess, HJ | 1 |
Reid, KJ | 1 |
Nishino, S | 1 |
Okuro, M | 1 |
Siegel, JM | 1 |
Russo, MB | 1 |
Stetz, MC | 1 |
Jenkins, CM | 1 |
Folen, RA | 1 |
Garnock-Jones, KP | 1 |
Dhillon, S | 1 |
Scott, LJ | 1 |
Rose, SH | 1 |
Curry, TB | 1 |
Czeisler, CA | 3 |
Walsh, JK | 3 |
Wesnes, KA | 1 |
Arora, S | 2 |
McBeth, BD | 1 |
McNamara, RM | 1 |
Ankel, FK | 1 |
Mason, EJ | 1 |
Ling, LJ | 1 |
Flottemesch, TJ | 1 |
Asplin, BR | 1 |
Thorpy, MJ | 1 |
Grady, S | 1 |
Aeschbach, D | 1 |
Wright, KP | 2 |
Schwartz, JR | 4 |
Khan, A | 1 |
McCall, WV | 1 |
Weintraub, J | 1 |
Tiller, J | 2 |
Black, JE | 1 |
Harsh, JR | 1 |
Kaiser, PR | 1 |
Valko, PO | 1 |
Werth, E | 1 |
Thomann, J | 1 |
Meier, J | 1 |
Stocker, R | 1 |
Bassetti, CL | 1 |
Baumann, CR | 1 |
Thorpy, M | 1 |
Darwish, M | 1 |
Bond, M | 1 |
Ezzet, F | 1 |
Erman, MK | 2 |
Seiden, DJ | 1 |
Dammerman, R | 1 |
Hirshkowitz, M | 1 |
Schmidt-Nowara, W | 1 |
Randazzo, AC | 1 |
Stone, KL | 1 |
Schweitzer, PK | 1 |
Westcott, KJ | 1 |
Hughes, RJ | 1 |
Kingsbury, L | 1 |
Niebler, GE | 1 |
Dinges, DF | 1 |
Basner, RC | 1 |
Keating, GM | 1 |
Raffin, MJ | 1 |
Hart, CL | 1 |
Haney, M | 1 |
Vosburg, SK | 1 |
Comer, SD | 1 |
Gunderson, E | 1 |
Foltin, RW | 1 |
Gill, M | 1 |
Haerich, P | 1 |
Westcott, K | 1 |
Godenick, KL | 1 |
Tucker, JA | 1 |
Neubauer, DN | 1 |
Lankford, DA | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 3 | 254 participants (Actual) | Interventional | 2004-03-31 | Completed | ||
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 4 | 385 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
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) | Interventional | 2008-08-31 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | Participants (Number) |
---|---|
Armodafinil 150 mg/Day | 112 |
Placebo | 104 |
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
Intervention | Minutes (Mean) |
---|---|
Armodafinil 150 mg/Day | 3.1 |
Placebo | 0.4 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 9.4 |
Matching Placebo | 5.0 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 0.7 |
Matching Placebo | 0.5 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 0.7 |
Matching Placebo | 0.6 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 0.6 |
Matching Placebo | 0.5 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 0.6 |
Matching Placebo | 0.5 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 3.3 |
Matching Placebo | 2.6 |
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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 0.7 |
Matching Placebo | 0.5 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.8 |
Matching Placebo | -1.8 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -6.6 |
Matching Placebo | -4.2 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.2 |
Matching Placebo | -1.5 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -0.5 |
Matching Placebo | -0.4 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -1.4 |
Matching Placebo | -0.7 |
"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))
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.2 |
Matching Placebo | -1.5 |
"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)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.2 |
Matching Placebo | -1.2 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 6.9 |
Matching Placebo | 3.7 |
"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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.6 |
Matching Placebo | -1.6 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 9.8 |
Matching Placebo | 4.9 |
"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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | -2.9 |
Matching Placebo | -1.8 |
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)
Intervention | Percentage of participants (Number) |
---|---|
150 mg/Day Armodafinil | 77 |
Matching Placebo | 57 |
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
Intervention | Percentage of participants (Number) |
---|---|
150 mg/Day Armodafinil | 78 |
Matching Placebo | 51 |
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
Intervention | Percentage of participants (Number) |
---|---|
150 mg/Day Armodafinil | 80 |
Matching Placebo | 56 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 82.5 |
Matching Placebo | 80.7 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 65.7 |
Matching Placebo | 46.1 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 59.9 |
Matching Placebo | 44.1 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|---|
150 mg/Day Armodafinil | 88.3 |
Matching Placebo | 96.3 |
11 reviews available for modafinil and Sleep Disorders, Circadian Rhythm
Article | Year |
---|---|
Excessive sleepiness in shift work disorder: a narrative review of the last 5 years.
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.
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.
Topics: Adaptation, Physiological; Attention; Caffeine; Education, Medical, Graduate; Energy Drinks; Fatigue | 2021 |
Pharmacological interventions for sleepiness and sleep disturbances caused by shift work.
Topics: Azabicyclo Compounds; Benzhydryl Compounds; Caffeine; Humans; Hypnotics and Sedatives; Melatonin; Mo | 2014 |
Armodafinil for excessive daytime sleepiness.
Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Humans; Modafinil; Narcolepsy; Sle | 2008 |
Armodafinil.
Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Clinical Trials as Topic; Humans; Modafinil | 2009 |
Managing the patient with shift-work disorder.
Topics: Benzhydryl Compounds; Combined Modality Therapy; Diet; Environment; Exercise; Female; Humans; Life S | 2010 |
Understanding and diagnosing shift work disorder.
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.
Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence; | 2005 |
Shift work sleep disorder: burden of illness and approaches to management.
Topics: Benzhydryl Compounds; Caffeine; Central Nervous System Stimulants; Circadian Rhythm; Cost of Illness | 2006 |
Armodafinil: a new treatment for excessive sleepiness.
Topics: Animals; Benzhydryl Compounds; Central Nervous System Stimulants; Drug and Narcotic Control; Drugs, | 2008 |
16 trials available for modafinil and Sleep Disorders, Circadian Rhythm
Article | Year |
---|---|
The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder.
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.
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.
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.
Topics: Academic Medical Centers; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Diso | 2009 |
Modafinil and zolpidem use by emergency medicine residents.
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.
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.
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.
Topics: Adult; Benzhydryl Compounds; Blood Pressure; Central Nervous System Stimulants; Double-Blind Method; | 2010 |
Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury.
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.
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.
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.
Topics: Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Chemotherapy, Adjuvant; Contin | 2003 |
Modafinil improves alertness, vigilance, and executive function during simulated night shifts.
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.
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.
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.
Topics: Adult; Attention; Benzhydryl Compounds; Central Nervous System Stimulants; Cognition; Double-Blind M | 2006 |
9 other studies available for modafinil and Sleep Disorders, Circadian Rhythm
Article | Year |
---|---|
Night work, sleepiness and modafinil.
Topics: Benzhydryl Compounds; Disorders of Excessive Somnolence; Humans; Modafinil; Sleep Disorders, Circadi | 2021 |
Keeping on the straight and narrow.
Topics: Attention; Automobile Driving; Benzhydryl Compounds; Female; Humans; Male; Modafinil; Motor Skills; | 2014 |
Gaps that wake you up.
Topics: Animals; Arousal; Benzhydryl Compounds; Central Nervous System Stimulants; Evoked Potentials, Audito | 2008 |
Armodafinil for the treatment of excessive sleepiness.
Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Dose-Response Relationship, Drug; Humans; J | 2009 |
Fatigue, countermeasures, and performance enhancement in resident physicians.
Topics: Academic Medical Centers; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Fati | 2009 |
Sleepiness versus sleeplessness: shift work and sleep disorders.
Topics: Amphetamines; Benzhydryl Compounds; Central Nervous System Stimulants; Circadian Rhythm; Diagnosis, | 2004 |
Modafinil, sleep deprivation, and cognitive function in military and medical settings.
Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Cognition; Humans; Military Personnel; Moda | 2005 |
Shift-work sleep disorder--the glass is more than half empty.
Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Disorders of Excessive Somnolence; Humans; | 2005 |
Does modafinil safely and effectively treat shift-work sleep disorder?
Topics: Adolescent; Adult; Arousal; Benzhydryl Compounds; Central Nervous System Stimulants; Double-Blind Me | 2006 |