CLINICAL STUDIES ON MODAFINIL

In a study by the University of Vienna in 1989, the effects of d-amphetamine and Modafinil were compared. Ten elderly patients whose average age was 68, spent 12 nights in a sleep laboratory. The results were that d-amphetamine caused deterioration in the quality of sleep, a reduction in total sleep time and REM sleep. Those patients taking Modafinil did not experience these side effects.

A second study used volunteers of a younger age group for twelve nights, and evaluated the quality of sleep, and morning awakening and behavior after taking an amphetamine versus Modafinil. The total sleep time and quality of sleep decreased after taking the amphetamine but this result did not occur after taking Modafinil.

Both studies showed that the amphetamine caused a drug induced impairment but Modafinil did not. The problem with taking regular amphetamines to increase alertness during the day means a loss of sleep time and a poorer quality of sleep, which causes more tiredness during the day. Thus, the patient will require larger and larger doses of the amphetamine.

Modafinil does not create deterioration in sleep time or sleep quality, so the two drugs use different methods to control alertness. Modafinil does not prevent the patient from sleeping if this is desired, but it will allow the person to remain awake and alert for long periods of time.

In the 1980’s, many studies of the effects of Modafinil were conducted on animals. These studies showed that Modafinil could improve alertness without creating an addiction or other negative side effects.

One study in 1993 in Paris, France, was carried out on rats. The result showed an increase in wakefulness and a decrease in feeding, which led to weight loss. Dosage levels were between 20 and 40 mg per kilogram. However, the drink-to-feeding ratio was not affected, showing Modafinil had no negative effect on water intake. The researchers concluded there was a link between sleep, eating, and metabolism.

In another study in 1995, eighty volunteer were sleep deprived for sixty hours. Either a placebo or 200 mg of Modafinil was administered every eight hours for three days. Throughout this time, the alertness of the volunteers was tested with a series of questionnaires. Those taking the Modafinil had been able to remain alert and coherent during the tests, but the group taking the placebo needed short micro-sleeps or naps to remain awake and their performance on the evaluation declined. These results confirmed that Modafinil is a suitable treatment for narcolepsy and hypersomnia.

In 1998, the French conducted a study on Modafinil as a treatment for narcolepsy and hypersomnia. Sleepiness and drowsiness were significantly reduced in 83% of the patients with hypersomnia and in 71% of the patients with narcolepsy. After using Modafinil for a period of three years, it was found that this medication did not create drug dependence or interfere with sleep patterns.

Another study on Modafinil was conducted by the French in 1996. In this research, one hundred and forty patients with narcolepsy participated, and ranged in age from eight to eighty. The duration of this study averaged 22 to 24 months. The participants were asked to evaluate the effectiveness of Modafinil in reducing excessive daytime drowsiness, and its side effects. Over 64% of the participants scored the benefit of Modafinil as good or excellent.

In a study involving 123 patients suffering from hypersomnia, the doctors administered Modafinil and found that 17% of the participants reported an excellent response, 63% reported a good response, 17% had fair results, and 3% showed no affects. The group showing side effects was small.

Other studies in 1994 and 1997 have also confirmed that Modafinil is an excellent drug to treat narcolepsy, hypersomnia, and cataplexy (a sleep disorder whose symptoms include Excessive Daytime Sleepiness, sleep attacks, sleep paralysis, and disturbed nighttime sleep). It was shown to improve long term memory in those with sleep apnea, while Modafinil did not decrease the quality or quantity of nocturnal sleep. It also had no effects on blood pressure or heart rate.

These studies confirm that Modafinil is a unique stimulant and is effective in treating a number of sleep conditions.

Military use of Modafinil

Several countries, including Belgian, Dutch, and US air forces, have used Modafinil in military operations. Stimulants of many types have been used over the years to maintain alertness in the troops.

The British used stimulants in the Falklands war, and the US Air Force used them during the Libyan air strikes. During the Gulf war, the French Foreign Legion used Modafinil for its operations in Iraq.
A French professor, Michel Jouvet, who is an authority on sleep disorders, claimed that “Modafinil could keep an army on its feet and fighting for three days and nights with no major side effects.”

Negative side effects of Modafinil

In clinical studies of three years or more, Modafinil has shown very minimal side effects. These include headaches and nausea. In some occasions, Modafinil has also caused hyper-salivation and a slightly increased pulse rate. Those with heart conditions should consult a doctor before using this medication. As well, those women who are pregnant or nursing should not use Modafinil.

Some drugs that may interfere with Modafinil include prazosin, phentolamine, or beta-blockers such as propranolol. These drugs are used to treat high blood pressure. As well, anti-depressants and mood altering drugs should also be used carefully when taking Modafinil. As well, it should be noted that Modafinil may increase the strength of anti-epileptic drugs (phenytoin, Dilantin / Epanutin).

Generally, the amount of Modafinil to take is 100 mg in a dose. The frequency of doses depends on the requirement to remain alert. If you need to stay alert all day, then taking 100 mg in the morning and afternoon may be required, or once every eight hours. The importance of taking the drug at the same time each day is high.

For those with serious sleep disorders such as narcolepsy, hypersomnia, or cataplexy, the dosage recommended is slightly higher. One hundred to 200 mg should be taken in the morning and afternoon, but when taking over 500 mg daily insomnia may result.

A comparison between Adrafinil and Modafinil

These two drugs are both eugeroics and seem to be very similar, except Adrafinil is less potent than Modafinil. Adrafinil is a mood enhancer and sharpens the ability to focus, and Modafinil is also a mood brightening and memory enhancing drug.

The recommended dosages of Adrafinil are between 600 mg to 1200 mg per day, whereas Modafinil is between 200 mg and 400 mg daily.

The cost of Adrafinil is substantially less than Modafinil, although it has some negative side effects such as stomach irritation, skin rashes, and when used for periods of three months or more, liver enzyme levels increase (although this effect is reversed when the medication is stopped). Long term use of Adrafinil requires regular blood testing to monitor the effects on the liver, which is an inconvenience for its users. None of these side effects have been seen with the use of Modafinil.

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