Job Safety

April 19, 2006

Provigil Is the Answer?

As many of my readers already know, there is a new and wildly popular drug called Provigil by Cephalon (generic name modfinal and is also marketed as “Alertec” by a rival company) to combat fatigue. Revenues from Provigil were $1.2 billion in 2005 and are growing. It is currently promoted to treat specific medical conditions such as narcolepsy but it is also being used as a “lifestyle drug” of choice for fighting drowsiness and fatigue.

So far the drug appears to be non-addictive and it does not cause hand shaking and heart racing like caffeine. Still the FDA is being cautious until more is know. Off-label prescriptions seem to be fueling the run up in demand. It has been used for over ten years so there should be a lot of reports on its down side. But a search of the internet shows only a few reported problems. For example: Anxiety, depression, diarrhea, difficulty sleeping, dizziness, dry mouth, headache, infection, loss of appetite, loss of muscle strength, lung problems, nausea, nervousness, prickling or tingling feeling, runny nose, sore throat. That’s not too bad for a drug that gives you a lift and keeps you working. It obviously does not bother a lot of people.

Is this the magic elixir, the solution to the alertness problem? Pilots report staying awake for three days with this product. It worries me because of the potential for psychological addiction and the long term effects of not getting enough sleep. Will it lead to more stressed out workers when the effects wear off? What happens to human performance after extended use? Does it affect judgement?

We will be conducting sleep deprivation trials this summer to calibrate the BLT alertness test. Maybe our next trial should include Provigil.

Just after I wrote the above, I found this interesting reference to a 2005 study.
Note the very substantial number of subjects and the severity of the sleep deprivation (85 hrs!).

Journal of Sleep Research
Volume 14 Page 255 – September 2005
doi:10.1111/j.1365-2869.2005.00468.x
Volume 14 Issue 3

Performance and alertness effects of caffeine, dextroamphetamine, and modafinil during sleep deprivation
NANCY J. WESENSTEN, WILLIAM D. S. KILLGORE and THOMAS J. BALKIN
Summary
Stimulants may provide short-term performance and alertness enhancement during sleep loss. Caffeine 600 mg, d-amphetamine 20 mg, and modafinil 400 mg were compared during 85 h of total sleep deprivation to determine the extent to which the three agents restored performance on simple psychomotor tasks, objective alertness and tasks of executive functions. Forty-eight healthy young adults remained awake for 85 h. Performance and alertness tests were administered bi-hourly from 8:00 hours day 2 to 19:00 hours day 5. At 23:50 hours on day 4 (after 64 h awake), subjects ingested placebo, caffeine 600 mg, dextroamphetamine 20 mg, or modafinil 400 mg (n = 12 per group). Performance and alertness testing continued, and probe tasks of executive function were administered intermittently until the recovery sleep period (20:00 hours day 5 to 8:00 hours day 5). Bi-hourly postrecovery sleep testing occurred from 10:00 hours to 16:00 hours day 6. All three agents improved psychomotor vigilance speed and objectively measured alertness relative to placebo. Drugs did not affect recovery sleep, and postrecovery sleep performance for all drug groups was at presleep deprivation levels. Effects on executive function tasks were mixed, with improvement on some tasks with caffeine and modafinil, and apparent decrements with dextroamphetamine on others. At the doses tested, caffeine, dextroamphetamine, and modafinil are equally effective for approximately 2–4 h in restoring simple psychomotor performance and objective alertness. The duration of these benefits vary in accordance with the different elimination rates of the drugs. Whether caffeine, dextroamphetamine, and modafinil differentially restore executive functions during sleep deprivation remains unclear.