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PubMed2000

Problems associated with switch to modafinil - a novel alerting agent in narcolepsy.

Modafinil is a novel medication recently approved for the treatment of narcolepsy and idiopathic hypersomnia. Commonly, patients had already been prescribed medications for their syndrome. This report outlines difficulties encountered in the clinical practice of switching patients to modafinil. Naïve subjects accepted modafinil best. Subjects withdrawn from amphetamine had the most problems and failure to withdraw. Venlafaxine hydrochloride combined well with modafinil to control cataplectic attacks. Usage of a progressive withdrawal protocol may ease the difficulties observed.

Adult↗
PubMed2000

Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults.

Our objective was to compare the efficacy of the new wake-promoting drug modafinil to that of dextroamphetamine for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. Twenty-two adults who met DSM-IV criteria for ADHD participated in a randomized, double-blind, placebo-controlled, three-phase crossover study comparing placebo, modafinil, and dextroamphetamine for the treatment of ADHD. The twice-daily study medications were titrated to doses of optimum efficacy over 4-7 days and then held constant during the rest of each 2-week treatment phase. Measures of improvement included the DSM-IV ADHD Behavior Checklist for Adults, the Controlled Oral Word Association Test (COWAT, using the letters C, F, and L version), Stroop, and Digit Span (Wechsler Adult Intelligence Scale version). For the 21 (96%) completers, the mean (+/- SD) optimum doses of modafinil and dextroamphetamine were 206.8 mg/day +/- 84.9 and 21.8 mg/day +/- 8.9, respectively. Scores on the DSM-IV ADHD Checklist (p < 0.001) were significantly improved over the placebo condition following treatment with both active medications. Performance on the COWAT (p < 0.05) reached trend levels of significance. Both medications were generally well tolerated. This preliminary study suggests that modafinil may be a viable alternative to conventional stimulants for the treatment of adults with ADHD.

Adolescent↗
PubMed1990

Electroencephalographic effects of modafinil, an alpha-1-adrenergic psychostimulant, on the sleep of rhesus monkeys.

An electroencephalographic (EEG) study on the rhesus monkey, primate model of human sleep, showed the significant wakening effect of a new psychostimulant, Modafinil. The first experiment, with single administration of three increasing doses of Modafinil (3, 6, and 12 mg/kg), was to determine the efficient threshold dose; the second experiment, with repeated administration of 22.5 mg/kg during 4 days, was to determine whether continuous wakefulness could be obtained without apparent behavioral disorders. Results of the first experiment showed a wakening effect above 6 mg/kg, but 12 mg/kg induced a sharp wakening effect with a significant decrease in all sleep stages. The second experiment induced important insomnia in all subjects for 4 days and 4 nights. No behavioral disorder was observed. Modafinil has a wakening effect at the dose of 6 mg/kg in rhesus monkeys and induces quasicontinuous wakefulness for 4 total days and nights with daily administration of 22.5 mg/kg, with no behavioral disorders. Modafinil should therefore find interesting applications in sleep disorder treatments.

Animals↗
PubMed1996

Modafinil decreases hypersomnolence in the English bulldog, a natural animal model of sleep-disordered breathing.

The English bulldog is a natural model of sleep-disordered breathing (SDB). This condition is marked by 1) hypersomnolence and 2) disordered breathing episodes that are most frequent and severe during rapid eye movement (REM) sleep. Modafinil has been found to increase arousal levels in animals and decrease excessive daytime sleepiness in humans. Therefore, in this study we focused mainly on the effects of the drug on total sleep time and sleep latency and secondarily assessed its effect on REM SDB. Five English bulldogs were implanted with subcutaneous electroencephalographic/electrooculographic (EEG/EOG) electrodes and instrumented with respiratory oscillation belts to measure abdominal and rib cage movements and an ear oximeter to measure saturation. The dogs were studied for approximately 8 hours each subsequent day on two consecutive days. On the first day, they received the vehicle dimethyl sulfoxide (DMSO) i.v. as a control. On the following day they received 10 mg/kg body weight of modafinil i.v. dissolved in the DMSO vehicle. Our findings indicate that modafinil significantly alleviates hypersomnolence (p < 0.05) in the bulldog, as evidenced by dramatically decreased mean total sleep time (from a control value of 50.5% to 8.3% with the drug) and increased mean sleep latency (from a control value of 71.0 minutes to a value of 346.6 minutes with the drug). We obtained limited data on the effect of modafinil on SDB because the drug either greatly diminished or entirely eradicated REM sleep in all five dogs.

Animals↗
PubMed1993

Effects of modafinil on symptomatology of human narcolepsy.

We studied the effects of modafinil, a putative central alpha-1 agonist, on the excessive daytime sleepiness (EDS) of 10 narcoleptic patients while using a double-blind design and objective measurements of vigilance. There were two treatment periods, in which either modafinil or placebo was used; each lasted four weeks and was preceded by a 2-week "run-in" period and separated by a 2-week "wash-out" period. The effects of treatment on EDS were evaluated by daily home questionnaires and a psychomotor performance test, the Four Choice Reaction Time Test (FCRTT). Modafinil reduced the daily number of sleep attacks significantly, and markedly improved performances during the FCRTT. Results of this study suggest that modafinil is effective in treating EDS in narcolepsy, and that noradrenergic mechanisms could be involved in the physiopathology of EDS in that disorder.

Adult↗
PubMedDate not supplied

Treatment of excessive daytime sleepiness in patients with Parkinson's disease with modafinil.

Excessive daytime sleepiness (EDS) may limit the symptomatic treatment of Parkinson's disease and can alter the patient's lifestyle significantly. Ten consecutive patients with Parkinson's disease on various dopaminergic drugs and EDS were recruited to a 4-week open-label trial of modafinil. Patients were evaluated using the Epworth Sleepiness Scale and Unified Parkinson's Disease Rating Scale part III. All but three patients, with previous history of intolerability of a dopamine agonist caused by EDS, remained on their baseline medications. Modafinil was titrated as needed to a maximum of 400 mg/day. The mean Epworth Sleepiness Scale score at baseline of patients completing the study (n = 9) was 14.22 (+/- 3.03). After completing the study on an average dose of 172 mg/day, the Epworth Sleepiness Scale score was 6.0 (+/- 4.87). Unified Parkinson's Disease Rating Scale scores were not affected by this medication. Side effects encountered were headache, generalized paresthesias, and hallucinations (n = 1 each, the patient developing hallucinations dropped out of the trial before completing 4 weeks of the study drug). The three patients who did not tolerate any increments of dopamine agonist before modafinil were able to tolerate further upward titration of the dopamine agonist. Modafinil may be effective in reducing EDS in patients with Parkinson's disease treated with dopaminergic drugs. It does not seem to worsen parkinsonian symptoms and may allow further increase in dopaminergic therapy in patients previously unable to tolerate this because of EDS.

Aged↗
PubMed1995

Interest of modafinil, a new psychostimulant, during a sixty-hour sleep deprivation experiment.

Modafinil, a new psychostimulant, was evaluated in eight healthy volunteers subjected to 60 hours of sleep deprivation. During continued wakefulness, vigilance was evaluated by self-assessment questionnaires, analogue visual scales, multiple sleep latency tests (MSLT), sleep logs, and continuous ambulatory electroencephalographic recordings (EEG). Modafinil (200 mg) or a placebo was given every 8 hours for three days; the sessions were separated by a 15 day wash out period. Results indicated a satisfactory level of vigilance, both subjective and objective, after the administration of modafinil, characterised by the quasi total absence of microsleep episodes which gradually occurred under placebo conditions. The confirmed wakening potency of modafinil makes this substance suitable for therapeutic use in patients with sleep disorders such as Gelineau's syndrome and hypersomnia.

Adult↗
PubMed2002

Effects of modafinil on heat thermoregulatory responses in humans at rest.

The effects of modafinil on heat thermoregulatory responses were studied in 10 male subjects submitted to a sweating test after taking 200 mg of modafinil or placebo. Sweating tests were performed in a hot climatic chamber (45 degrees C, relative humidity <15%, wind speed = 0.8 m x s(-1), duration 1.5 h). Body temperatures (rectal (Tre) and 10 skin temperatures (Tsk)), sweat rate, and metabolic heat production (M) were studied as well as heart rate (HR). Results showed that modafinil induced at the end of the sweating test higher body temperatures increases (0.50 +/- 0.04 versus 0.24 +/- 0.05 degrees C (P < 0.01) for deltaTre and 3.64 +/- 0.16 versus 3.32 +/- 0.16 degrees C (P < 0.05) for deltaTsk (mean skin temperature)) and a decrease in sweating rate throughout the heat exposure (P < 0.05) without change in M, leading to a higher body heat storage (P < 0.05). AHR was also increased, especially at the end of the sweating test (17.95 +/- 1.49 versus 12.52 +/- 1.24 beats/min (P < 0.01)). In conclusion, modafinil induced a slight hyperthermic effect during passive dry heat exposure related to a lower sweat rate, probably by its action on the central nervous system, and this could impair heat tolerance.

Adult↗
PubMed2005

Dose effects of modafinil in sustaining wakefulness in narcolepsy patients with residual evening sleepiness.

Excessive sleepiness associated with narcolepsy lasts throughout the waking day. The authors conducted two randomized, double-blind studies to compare the efficacy of modafinil once-daily versus split doses in maintaining wakefulness throughout the day. Fifty-six patients received modafinil. The split-dose regimens were significantly more effective than the 200-mg once-daily regimen for sustaining wakefulness in the late afternoon/evening. All modafinil dosing regimens were well tolerated. In patients who experience excessive sleepiness in the late afternoon/evening, despite satisfactory treatment earlier in the day, a split dose of modafinil may promote wakefulness throughout the waking day.

Adolescent↗
PubMed2006

Modafinil for drooling in cerebral palsy.

Two patients with spastic cerebral palsy recently treated with modafinil at the Walter Reed Army Medical Center child neurology clinic have stopped drooling. This occurred after starting modafinil for spasticity and without other changes in the patients' treatment programs. The decrease in drooling is to a remarkable degree. Both patients had a chronic problem with drooling. One patient has gone from wearing a bib or bandanna, which was constantly wet from drooling to being essentially dry. After starting modafinil, both patients stopped drooling. The parents initially observed decreased drooling at home. Clinic appointment examinations and evaluations at physical therapy confirmed these observations. Better coordination and speech have been noted in each patient. Modafinil improves drooling in at least some patients with spastic cerebral palsy. The decreased drooling is due to improvements noted in swallowing.

Adolescent↗
PubMedDate not supplied

Modafinil to treat fatigue in amyotrophic lateral sclerosis: an open label pilot study.

An open label trial of modafinil was conducted to determine whether it would be tolerated and effective in treating fatigue for people with amyotrophic lateral sclerosis (ALS). Fifteen patients with ALS were treated for two weeks with either 200 mg or 400 mg of modafinil. Reported side effects of the medication were mild and included diarrhea, headache, nervousness, and insomnia. Side effects did not result in any study dropouts. Following treatment, mean scores on the Fatigue Severity Scale (FSS) decreased from 51.3 (SD 9.2) to 42.8 (SD 10.2). On the Epworth Sleepiness Scale (ESS), mean scores decreased from 8.2 (SD 2.0) to 4.5 (SD 2.4). Reductions in both the FSS and the ESS were significant at p < 0.001. Mean scores on the self-report version of the Functional Independence Measure (FIM-SR) increased from 115.2 (SD 5.6) to 118.1 (SD 5.4), with p < 0.01. This pilot study suggests that modafinil is well-tolerated and may reduce symptoms of fatigue in ALS. Further blinded, controlled studies of modafinil in larger numbers of ALS patients are warranted.

Amyotrophic Lateral Sclerosis↗
PubMed2005

Double-blind, placebo-controlled study of modafinil for fatigue and cognition in schizophrenia patients treated with psychotropic medications.

OBJECTIVE: To assess the effects of modafinil on fatigue, symptoms, attention, working memory, and executive functioning in schizophrenia patients treated with psychotropic medications. METHOD: Twenty-four patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder (10 men and 14 women) were randomly assigned to modafinil up to 200 mg a day (N = 13) or placebo (N = 11) as an adjunct therapy in an 8-week, double-blind, placebo-controlled study. Data were collected from May 18, 2001 to September 11, 2003. RESULTS: Four subjects terminated the study early, including one because of worsening of psychosis during the first week taking modafinil. In the modafinil (N = 10) and placebo (N = 10) groups, fatigue improved significantly over time (p < .01), but there were no differences between groups on changes in fatigue, positive and negative symptoms, or cognition. CONCLUSION: Fatigue improved in both groups, and there were no differences between groups on changes in fatigue, symptoms, attention, working memory, or executive functioning. Lack of differences between groups may be due to small sample size or possible regression to the mean in the placebo group.

Adult↗
PubMed1998

[Effect of modafinil on electroretinograms of Lycosa tarentula in relation visual circadian rhythm (Araneae, Lycosidae)].

Injections of modafinil, a drug able to induce in vertebrates an awakening effect via an effective central alpha 1-adrenergic tone, induce modifications of the amplitude and latency of electroretinograms (ERGs) in the spider Lycosa tarentula, during dark adaptation. Results of experiments are different from one eye type to another as circadian activity rhythms of the retinae also differ. Modafinil induces a decrease of diurnal amplitudes and has no effect on nocturnal amplitudes of ERGs of anterior-lateral eyes; in the case of posterior-median eyes, the amplitudes are increased in daytime as well as at night. Prazosin, antagonist of alpha 1-adrenergic receptors, injected after modafinil, induces a decrease of the amplitudes of ERGs in the same eyes. These results are discussed in relation to the visual activity of this species, both diurnal and nocturnal. The concepts of waking state versus sleep are not precisely characterized in arachnids, so that the effects of modafinil on L. tarentula may not be considered like those described in vertebrates.

Animals↗
PubMed1999

Effects of modafinil and amphetamine on sleep-wake cycle after sleep deprivation in cats.

AIM: The effects of modafinil and amphetamine on sleep-wake cycle and cortical power spectrum were assessed in the cats before and after sleep deprivation. METHODS: The sleep deprivation in the cats was used with the water tank technique. Cats were administrated with modafinil (5 mg.kg-1 p.o.) or amphetamine (1 mg.kg-1) before and after sleep deprivation. RESULTS: The waking effect of 8-10 h induced by modafinil before and after sleep deprivation was similar and was not followed by an increase in sleep rebound. On the contrary, the arousal effect about 8 h evoked by amphetamine after sleep deprivation was less lasting than that of 10-12 h observed in normal conditions and followed by an amplified rebound in both deep slow wave sleep and paradoxical sleep. CONCLUSION: These results suggest the efficiency of modafinil against somnolence and hypersomnia without increasing subsequent sleep.

Amphetamine↗
PubMed2003

[Effects of modafinil on visual and auditory reaction abilities and subjective fatigue level during 48 h sleep deprivation].

OBJECTIVE: To investigate the effects of modafinil, a new central stimulant, on visual and auditory motion reaction ability and subjective fatigue level during 48 h sleep deprivation (SD). METHOD: Six male healthy young volunteers were exposed to two 48 h periods of continuous wakefulness during the crossover experiment. In one period, three 200 mg doses of modafinil were given and in the other, separated by two weeks, matching placebos were administered. The SD time started from 7:00 of the first day to 7:00 of the third day. Drugs were given at 0:00, 16:00 of the second day and 0:00 of the third day. Variables, including visual and auditory motion reaction time, attention distribution, critical flicker fusion frequency (CFF), Stanford sleepiness scale (SSS) and rating of perceived exertion (RPE), were tested at 21:00 of the first day and 1, 3, 5, 7 h after each drug administration. RESULT: After 2-3 does of modafinil, the CFF level was obviously enhanced while the scores of Stanford sleepiness scale and RPE were markedly reduced. The visual and auditory motion reaction ability, as well as the attention distribution, showed no significant change. CONCLUSION: Modafinil can effectively reduced the subjective fatigue and sleepiness levels during SD.

Adolescent↗
PubMed2005

Psychostimulants and G tolerance in rhesus monkeys: effects of oral modafinil and injected caffeine.

INTRODUCTION: Caffeine and modafinil are psychostimulants that may be taken by fighter aircraft pilots to reduce fatigue. Fighter pilots are subjected to high positive G loads that reduce cerebral blood flow and consequently may induce G-LOC. The aim of the experiment was to determine whether these drugs may reduce tolerance to G stress. METHODS: Seven adult male rhesus monkeys participated in the experiment. Five were equipped with ECoG and ECG wires and underwent two G tests (A and B). Each experiment consisted of five centrifuge runs. Before the runs, the monkeys received no drug (control) or were given either 7.5 mg x kg(-1) caffeine IM or 64 mg x kg(-1) modafinil PO or the corresponding vehicles. The runs were performed up to +13 Gz with an onset rate of 0.1 G x s(-1) (test A) or 3 G x s(-1) (test B). The run was ended when the electrical activity of one ECoG channel had disappeared (i.e., G-LOC). RESULTS: In experiment A, drug administration had no significant effect. In experiment B, the injection of the caffeine-free solvent caused a delay in G-LOC compared with the control condition (no administration). Caffeine solvent also induced an increase in plasma osmolality. DISCUSSION: Modafinil administration has no significant effect on the G tolerance of rhesus monkeys. Regarding caffeine, the drug seems to have caused the reverse effect compared with the solvent. CONCLUSIONS: Caffeine and modafinil administration had no significant effect on the G-tolerance of rhesus monkeys when compared with controls. This result needs to be confirmed in humans.

Acceleration↗
PubMed1989

Differential effects of the new central adrenergic agonist modafinil and d-amphetamine on sleep and early morning behaviour in elderlies.

Modafinil (CRL 40476) is a new central alpha-adrenergic agonist with vigilance-promoting properties. In a double-blind, placebo-controlled sleep laboratory study its single-dose effects on sleep and early morning behaviour were investigated and compared with d-amphetamine. Ten elderly healthy volunteers (mean age: 68 years) spent 12 nights in the sleep laboratory: one adaptation night, one baseline night, five drug nights (100 mg and 200 mg modafinil; 10 mg and 20 mg d-amphetamine; placebo) and five subsequent washout nights. The drugs were administered orally in one week intervals at 10:00 p.m., and all-night somnopolygraphic investigations were performed between 10:30 p.m. and 6:00 a.m. A self-rating scale for sleep and awakening quality as well as psychometric tests were completed in the morning. d-amphetamine caused a dose-dependent impairment of sleep maintenance and sleep architecture, while modafinil did not. Thus, a significant reduction of total sleep time, REM-sleep and sleep stage 2 was seen after d-amphetamine when compared to placebo and 100 mg modafinil. Corresponding with these objective results, subjective sleep quality deteriorated significantly only after 20 mg d-amphetamine as compared to placebo. Morning investigations revealed an increase of CFF after 20 mg d-amphetamine. Pulse rate, evening and morning blood pressure remained unchanged. These findings suggest a different mode of action of the two compounds.

Aged↗
PubMed2000

Effect of modafinil on cerebral blood flow of anaesthetised rats. Comparison with amphetamine.

This experiment compares the cardio- and cerebrovascular effects of modafinil and amphetamine administered to rats. Injections of 300 mg/kg and 600 mg/kg modafinil i.p. had no major effect. In contrast, injection of D-amphetamine sulfate (5 mg/kg i.v.) induced a long-lasting rise in heart rate and in mean arterial blood pressure (MABP). Amphetamine administration also elicited a 70-min-long increase in cortical cerebral blood flow which was proportional to the increase in MABP. We conclude that, contrary to amphetamine, modafinil has no effect on perfusion in the cerebral cortex of anaesthetised rats.

Amphetamine↗