DOCTORS HAVE been warned to severely restrict their use of a wakefulness promoting drug with a history of abuse by students seeking to boost exam performance because of new concerns about its safety.
In its latest Drug Safety newsletter, the Irish Medicines Board has advised prescribers that the drug Modafinil must no longer be used to treat excessive sleepiness associated with sleep apnoea (a condition where breathing stops during sleep), chronic shift work sleep disorder and other causes of hypersomnia.
Modafinil, which is marketed under the trade name Provigil, may now only be prescribed for adults with excessive drowsiness due to narcolepsy.
Although never sanctioned by global drugs regulators for short-term use by students preparing for exams or facing imminent project deadlines, there is some evidence that Modafinil has been used in this way.
A 2009 survey of Cambridge University students found 10 per cent of students had said they used performance-enhancing drugs to help them study.
In the US, it has been reported that up to 25 per cent of students at some US universities have been purchasing drugs such as Ritalin and Provigil in an effort to boost memory and concentration.
A recent systematic review by German doctors found Modafinil improved attention for well-rested individuals, while maintaining wakefulness, memory and executive functions to a significantly higher degree in sleep-deprived individuals than did a placebo (dummy pill).
However, repeated doses of Modafinil appeared to induce overconfidence in a person’s own cognitive performance and the drug lost its potency as sleep deprivation increased.
But the European Medicines Agency has carried out a safety review of the wakefulness drug and concluded that the risk-benefit balance was positive only for patients with the sleep disorder narcolepsy.
It has also expressly forbidden the use of Modafinil in people up to the age of 18 and in patients with uncontrolled high blood pressure.
It wants doctors to carry out an electrocardiogram of the heart before starting the drug and it wants those prescribed Modafinil to have their blood pressure and heart rate monitored regularly.
The IMB advises that the drug must be used with caution in patients with a history of psychosis, depression or mania.
It also wants doctors to review the treatment of patients taking Modafinil at their next routine appointment.
“Modafinil should be withdrawn in patients who experience skin reactions or psychiatric symptoms,” the regulator says.