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Administration of modafinil results in electrophysiological changes indicative of increased alertness and improvements in objective measures of ability to sustain wakefulness. The efficacy of modafinil in patients with obstructive sleep apnoea OSA exhibiting excessive day time sleepiness despite treatment with continuous positive airways pressure CPAP has been studied in short term randomised controlled clinical trials. In light of this, and because of its known safety profile, the demonstrated benefit is outweighed by the risks.

Three epidemiological studies all utilizing a long-term observational inception cohort design were conducted in administrative databases assessing the cardiovascular risk of modafinil. One of the three studies suggested an increase in the incidence rate of stroke in modafinil treated patients compared to patients not treated with modafinil, however, results across the three studies were not consistent. The pharmacokinetic properties of modafinil are linear and time-independent.

Systemic exposure increases in a dose proportional manner over the range of mg. Food has no effect on overall modafinil bioavailability; however, absorption t max may be delayed by approximately one hour if taken with food. Modafinil is metabolized by the liver. The dosage of modafinil should be reduced by half in patients with severe hepatic impairment. For patients 6 to 7 years of age, the estimated half-life is approximately 7 hours and increases with increase in age until half-life values approach those in adults approximately 15 hours.

Higher concentrations of one of the circulating metabolites, modafinil sulfone, are present in children and adolescents as compared to adults. Once steady-state is reached, the pharmacokinetic properties of modafinil do not appear to change with continued administration for up to 1 year. Toxicology studies by single and repeated dosing have revealed no particular toxic action in animals. There was no effect on fertility and no evidence of teratogenic potential at systemic exposures equivalent to the maximum recommended human dose.

Reproduction toxicity studies revealed no effect on fertility, nor any teratogenic effect, nor any effect on viability, growth or development of the offspring. Animal exposure to modafinil, based on actual plasma levels in the general toxicology, reproductive and carcinogenicity studies, was less than or similar to that expected in humans. This circumstance is the result of metabolic auto-induction noted in the pre-clinical studies. In the rat peri-post-natal study, modafinil concentration in milk was about Any unused product or waste material should be disposed of in accordance with local requirements.

Continue typing to refine. Active ingredient modafinil. Qualitative and quantitative composition 3. Pharmacological properties 5. Pharmaceutical particulars 6. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. Tablet White to off-white, capsule shaped, uncoated tablets, debossed with '41' on one side and 'J' on the other side.

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