Safety concerns with modafinil

I am concerned by the statement from researchers promoting their work that modafinil is world’s first safe “smart drug”. Understandably, this was the headline in The Pharmaceutical Journal’s news item. Newspapers and journals have repeated the same message and I have challenged the statement in The BMJ.

The conclusion about the safety of modafinil is based on small studies, many of which involved subjects taking only one tablet. My letter to the editor of The BMJ describes the methodological bias (The BMJ 2015;351:h4573).

I co-wrote a British Medical Association review of cognitive enhancers that was published in August 2015. It summarises (on page 9) the evidence relating to safety concerns about modafinil that caused the European Medicines Agency to restrict its use. As we know, there is increased interest in and use of “smart drugs” despite expectations exceeding benefits. Advocating that a drug is safe outside of its approved indications when the wider and more appropriate evidence is to the contrary could be harmful.

Paul J Nicholson OBE

Chairman, British Medical Association Occupational Medicine Committee