Several agencies and researchers have conducted several tests to find out the safety assessment of Provigil. The discussion on this aspect of the medicine provides initial results that indicate this medicine may be a good alternative for an effective treatment for fatigue in the users. The final conclusion of the tests indicates that Provigil is ideally a very significant addition to the pharmacological treatment options that are currently available for fatigue management.
However, there are a few other trials that are ongoing to assess the safety aspect of Provigil in the long term along with its efficacy in treating fatigue.
- The test results showed that nearly 90% of the patients enrolled completed all four phases of the treatment during the study.
- It was noted that during the treatment process the most frequent and common adverse events of Provigil were headache, anxiety and nausea.
- The adverse events experienced by the patients were however reported to be very mild by at least 63% of the participants.
- On the other hand there were only 37% patients that said that they experienced effects that are moderate in nature.
- No one however said that they experienced serious effects of the treatments and needed further medical assistance.
These facts indicate clearly that the medication is safe to use and has little to no downsides when patients are treated with only 200 mg of the medication every day.
Side effects on higher dose
On the other hand, when the dose of treatment was raised to 400 mg per day it was noticed that the most common and frequent side effects happed to be asthenia. This is a specific situation that is described as worsened fatigue.
- While the patients taking 400 mg a day were found to number 14% of the total respondents
- It was 3% when the patients were treated with 200 mg of the pill per day and
- When compared with the patients given a placebo run in, it was found to be 8%.
Other common and frequent side effects were found to be nausea, headache and nervousness. In such specific side effects, it was found that out of all the patients treated with 400 mg of Provigil 58% said they experienced mild effects and 39% experienced moderate effects. Once again, there were no reports of any serious adverse effects experienced by any of the patients all though the four phases of the treatment with 400 mg of Provigil.
Need and reason for discontinuation
No matter the above facts signify the safety aspect of Waklert or Provigil it cannot be said that the tests did not show any serious effects at all. Since this is a comparative and most authentic study, the researchers also produced the more serious nature of the side effects of Provigil. This helped them to arrive at a more decisive and accurate conclusion.
- It was found that during the tests, there were about 10 to 15 % patients that reported that they found their conditions and symptoms worsening after taking Provigil 200 mg in a day.
- Though the moderate effects were found to be more than the mild effects, the reasons for these serious adverse events were found to be possibly related to treatment.
However, it did not need any immediate initiation of additional treatment with the likes of steroids. In most of the times the issues were resolved even without requiring making any adjustments to the dosage of Provigil.
On the other hand, when the patients on a placebo run were considered it was found that a few patients reported severe conditions to the extent of continued exacerbation of symptoms. In some patients it was even required to discontinue the treatment and put an end to the study.
That is not all. Considering the patients under placebo run there were a few who required receiving steroid treatment for 5 days. There were even a few patients who even reported to experience worsening of the symptoms during the placebo wash out period. This however was considered to be insignificant and unrelated to the study.
In the end, out of all the results and after compilation and comparison of these all it was concluded that the most common symptoms of side effects irrespective of its degree and nature are:
- Headache experienced by 25% of patients
- Dry mouth by another 25% respondents
- Anxiety by 25% patients the most.
The other patients reported of different symptoms such as:
- Agitation and
- Sexual function abnormality.
This leads to the discussion phase of the results of the tests to further emphasize on the safety aspect of Provigil.
The researchers unanimously agreed that whether it is bought from RXShopMD.com or any other store of its repertoire, the treatment with 200 mg a day of Provigil produced no serious side effects. That means if the user follows the instructions for its dosage and usage, there is little to no chance of any side effects.
When all the three fatigue scales are considered there has been a significant improvement seen in the fatigue scores when compared with scores that are got from the placebo run in phase.
The researchers also considered the results for 400 mg dosage of Provigil. They found that the mean fatigue scores were not maintained with the 400 mg a day dosage with the 200 mg dosage a day. Though the reasons for this are particularly unclear, there are several explanations and probabilities for it, said the researchers. It includes:
- The development of tolerance by the users or tachyphylaxis
- The higher doses masked the adverse effects and even any possible benefits on fatigue and
- The possibility of the effect of the treatment being self-limited was not also ruled out by the researchers.
All these results and inferences prove that the safety profile of Provigil is high and the treatment of it with the patients was well tolerated as well. As far as the adverse effects are concerned, these are all mild and transient in nature, provided the user uses it within limits.