Federal Schedule Listing Schedule Iv Dea no 1680 USA Availability Prescription Pregnancy Category C

Uses. This drug is a medical treatment for narcolepsy and other conditions involving difficulty in staying awake. The substance also improves vigilance. In the 1990s U.S. Air Force researchers called for exploration of the drug's potential in assisting military missions. Investigators have found that the compound may assist aircraft pilots in maintaining a better performance level when deprived of sleep for extended periods. An experiment indicated that the drug can help military personnel engage in sustained operations for 64 hours without sleep, with fewer unwanted effects than amphetamine has. A French military experiment showed the drug could be used along with short naps to permit extended operations without normal sleep periods. Additional study has shown, however, that people using the compound are less aware of reduced quality of performance; in comparison, sleep-deprived individuals who use dextroamphetamine or a placebo have a more accurate assessment of their capabilities. Thus, from a practical standpoint, sleep-deprived persons using modafinil may be overconfident and try to do things that should not be attempted.

Modafinil is used against obstructive sleep apnea, in which people have temporary breathing stoppages while asleep and which can make them sleepy the next day. Experiments find that although modafinil helps people stay awake, it does not interfere with the quality of their sleep, as dextroamphet-amine does. Modafinil has helped patients respond better to antidepressant therapy while also reducing their feelings of weariness. Favorable results have been seen in experiments using the drug against attention deficit hyperactivity disorder (ADHD) and against organic brain problems caused by alcoholism. An animal study indicates the substance may have potential for treating Parkinson's disease. Some authorities speculate that the compound may reduce brain problems caused by aging. Modafinil makes animals more active.

Drawbacks. Modafinil can produce euphoria in humans. Headache, dry mouth, sore throat, appetite loss, nausea, diarrhea, uneasiness, depression, insomnia, fever, infection, and weakness have been reported by modafinil users. Among cardiac patients, unwanted actions may include heart palpitations, chest pain, and breathing difficulty. High doses have caused tremors, faster pulse rate, high blood pressure, peevishness, confusion, and aggression. Although the compound is a stimulant, it has a risk of adversely affecting skills needed for operating dangerous machinery such as automobiles.

A modafinil dose lasts a shorter time in young females than in young males.

Abuse factors. Modafinil's chemical properties reduce or even eliminate its effects if injected or smoked, reducing its convenience for abuse. Studies indicate the drug has less abuse potential than many other stimulants, but monkeys will self-administer modafinil, a traditional sign of addictive potential in a substance. Scientists running one monkey experiment noted, however, that only massive doses would interest the animals; even an amount of modafinil 200 times the size of a dextroamphetamine dose was not enough to get them to self-administer the two drugs at the same rate. In a rat test the rodents acted like modafinil has some effects reminiscent of cocaine. In one scientific study persons with a history of drug abuse found modafinil's actions pleasurable and similar to those of methylphenidate. People using modafinil daily for 9 weeks showed no dependence; and a study of 140 patients who used the drug for varying amounts of time, ranging from 1 month to almost 10 years, revealed no dependence. Tests of humans taking modafinil daily for 40 weeks indicated no development of tolerance.

Drug interactions. Modafinil can make birth control pills and implants less effective. A laboratory test indicated that the drug may reduce blood levels of cyclosporine, an immunosuppressant used to help organ transplant patients. Modafinil may raise blood levels of diazepam, tricyclic antidepressants, the anti-blood clot medicine warfarin, and the epilepsy medicine phenytoin.

Cancer. Laboratory tests have not found indications that modafinil causes cancer.

Pregnancy. Fetal injury emerged in pregnant rats receiving 10 times the normal maximum human dose of modafinil, but pregnant rabbits receiving the same dosage did not show fetal damage attributable to the substance. At lower doses rat offspring appeared normal, and milk from nursing rats receiving the drug did not seem to harm the pups. Effects on human pregnancy and milk are uncertain.

Additional scientific information may be found in:

Akerstedt, T., and G. Ficca. "Alertness-Enhancing Drugs as a Countermeasure to Fatigue in Irregular Work Hours." Chronobiology International 14 (1997): 145-58. Baranski, J.V., and R.A. Pigeau. "Self-Monitoring Cognitive Performance during Sleep Deprivation: Effects of Modafinil, D-Amphetamine and Placebo." Journal of Sleep Research 6 (1997): 84-91. Lyons, T.J., and J. French. "Modafinil: The Unique Properties of a New Stimulant."

Aviation, Space, and Environmental Medicine 62 (1991): 432-35. "Modafinil for Narcolepsy." Medical Letter on Drugs and Therapeutics 41 (1999): 30-31. Rugino, T.A., and T.C. Copley. "Effects of Modafinil in Children with Attention-Deficit/Hyperactivity Disorder: An Open-Label Study." Journal of the American Academy of Child and Adolescent Psychiatry 40 (2001): 230-35.

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