Nightmare on Provigil Street
I love to sleep. I love going to sleep, I love sleeping, and I love waking up after a great night’s sleep. The only thing I don’t like about sleep is how much time it takes, but other than that I’ll take as much as I can get. That said, I often wonder how much more I would get done in a day if I didn’t have to sleep. That would be a whole other 8 hours (well, maybe 6) that I would get that I could do other things — that’s just shy of 2 full days over the course of a week for me, a whole weekend of time.
There are many people who, for whatever reason, can’t easily partake in sleep due to a condition known as chronic insomnia. A number of drugs have been created in order to help with the condition, including Ambien, Lunesta and Sonata. A recent article published on Web MD found that while all are effective, none stands out as the best medication. Additional studies are needed for those who suffer from insomnia, and a better understanding of which drug treats which underlying symptom best. To read more from Web MD, click here, and to read more about the herbal remedies on Sleeping Pills Reviewed.com, click here.
But you probably have heard me talking about this before, in my article called “Sleepless Beauty,” where I explore the impact of sleep deprivation based on a study done at Northwestern University. What prompted my post today was an article published in October 28th’s News-Medical.Net, which describes a new warning issued by the U.S. Food and Drug Administration (FDA) against Provigil, a “stay awake” drug sold by drug manufacturer Cephalon.
The original intent of Provigil was to treat people suffering from narcolepsy and obstructive sleep apnea, conditions characterized by the sudden onset of sleep at seemingly random moments throughout the day, regardless of how well-rested the person is. In addition, the drug has been prescribed by doctors for several “off-label” uses such as treatment for age-related memory decline, attention deficit disorder, depression, high-pressure job fatigue, memory problems associated with Alzheimer’s disease, and other indications related to sleepiness and short-term memory loss. It even has been used to treat cocaine addiction and as a performance enhancer in the military for pilots and soldiers in combat situations to help them stay awake and alert for extended periods of time.
Now, I couldn’t imagine why one would take a drug to avoid sleep, given how much I love it, and the FDA’s warning provides yet another reason to avoid its use if you share my opinion. According to government scientists studying statistics from the drug and its use, side effects can include hallucinations, anxiety and suicidal thoughts, but the most frightening are the instances of Stevens-Johnson Syndrome, which starts as a small red rash on the skin but can rapidly blossom into a condition where skin literally peels off the body. The resulting raw skin layer invites deadly infections to enter the body easily and effectively, and could result in additional complications for the patient.
The FDA says patients taking the drug should cease its use immediately. While most of the off-label treatments can be treated with other drugs, Provigil is the only FA-approved prescription medicine for treatment of excessive sleepiness associated with Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD), and it is one of Cephalon’s biggest-selling drugs. You can read more about the warning and its consequences here.
I wonder if this kind of drug will get the black box label (see my article, “Death by Black Box,” for more information on this special FDA label)? Unfortunately, the News-Medical.net article had no statistics indicating what percentage of the test group experienced the side-effects described above, regardless of their severity. Clearly, however, they were abundant enough to warrant a warning from the FDA.
I am abundantly thankful I don’t suffer from any condition that would require that I take Provigil, as I’m sure I’d be in distress now from the FDA’s communication. But for those people who were taking it for “off-label” conditions, how do you feel about their dilemma? Do you think they should have been taking the drug in the first place? What other drugs are used for “off-label” symptoms, and are you using any of them? How would you feel if they took the drug away, or issued a statement to indicate that their use was not permitted for anything but the condition described on the label?
As always, your comments are welcome.
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I was prescribed Provigil by a psychiatrist because I had decreased energy as a symptom of my depression. This was just before the latest warning came out in late October of 2007. When the warning came out, my psychiatrist did not inform me DESPITE my history of depression, so I happily kept taking Provigil. Provigil DOES impair one’s thinking and ability to act rationally. Three months later, after serious degeneration of my mind, I very impulsively sliced my wrists. Thankfully my roommate found me. Provigil did give me more energy – it also increased my anxiety, nervousness, made me paranoid, and I was unable to sleep any more than three hours at a time. I became a walking skeleton- I lost 20 pounds in a month and a half, making me terribly underweight. 2 days after being taken off the drug, the ‘craziness’ subsided and my appetite returned.
Maybe Provigil does well for some people, but for me it was BAD BAD BAD news. I just think it is important to know all of the risks involved with taking the drug. I didn’t know them, and thought it was all due to my depression. At least the warning is out now and people will know.