Should We Be Wary of Magic Pills for Shift Work Sleep Disorder?

by LaertesCTB/via Flickr

Nurses of course work shifts—in my first year in the ER, I rotated monthly: one month on days, one on evenings, and one on nights. Nights were the hardest—coming to work at 11:30 pm when everyone else was still partying or heading to bed. Then trying to sleep in a 3^rd floor apartment on Second Avenue in Manhattan—you could still hear all the street noises with the windows closed. You never quite felt yourself on a night shift.

But eventually you found ways to deal with sleeping—you got used to the noise and the light (earplugs and sleep masks helped). And then there was coffee or Coke or Pepsi and chocolate; for some it was NoDoz because they didn’t like coffee. Many of us found it worked well to sleep once kids went off to school and until they got home; that allowed for some errands to get done and for some family time at dinner. Then, a quick “laydown” for a nap around  9 pm for an hour or so was enough to get us through the night shift. Colleagues without children would head right out to do chores early in the morning and then head home to sleep from 1 pm to 9 pm. Summers were great—we’d all head to the beach right off shift at 8 am, have the beach to ourselves until noon, and then head home to sleep. We all eventually found our method or “drug of choice.”

But now there is a real drug that’s being marketed to nurses and other health and shift workers. Apparently “shift work sleep disorder” is a real diagnosis and the FDA has approved Nuvigil (armodafanil) as a treatment. (In fact, treating shift work fatigue with prescription drugs isn’t as new as I’d thought: Nuvigil is the company’s chemically similar successor to Provigil

At first I thought it was cynical to market a drug to treat ordinary sleepiness due to shift work—a condition we didn’t use to describe as a “disorder.” But as I thought more about it, I wondered what the difference really is between taking an FDA-approved prescription and drinking four or five cups of coffee, or popping some NoDoz caffeine pills?

I did check the drug information about armodafanil. It was studied in four clinical trials involving 1,100 people; trials did not last longer than 12 weeks (so no long-term study).

I learned that, while the chance of adverse effects seems relatively minimal,

“NUVIGIL is a federally controlled substance (C-IV) because it has the potential to be abused or lead to dependence. And patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that NUVIGIL therapy will not adversely affect their ability to engage in such activities.”

So I wonder: does manipulating multiple central lines count as “hazardous machinery”? Does working with ventilators and arterial lines and calculating dosages for vasoactive medications for neonates count as hazardous machinery? Perhaps before prescribing this medication for shift workers, one should do a clinical trial evaluating the drug in real world use, where the real world problems will occur. Or maybe hospitals could have nap rooms where workers could take a break and get a bit of sleep to refresh themselves. (And how many of us have never taken an opportunity to catch a short nap on our break? Researchers say it’s time we acknowledge it and openly allow it.)

And then there’s this: as a pharma-watchdog blog pointed out just yesterday, European regulators have expressed concerns about Provigil, pointing to “safety concerns over psychiatric disorders, skin and subcutaneous tissue reactions . . . ” For now they are restricting the drug’s use to just the treatment of narcolepsy, while ruling it out for the treatment of excessive sleepiness associated with shift work sleep disorder, hyerpsomnia, and sleep apnea. Will Nuvigil be next?

We know medication errors occur when people are tired and overworked. But we must be careful that, in our intent to minimize one factor, we don’t introduce another problem.