Millions of people around the world rely on antidepressants in the treatment of clinical depression and, to a lesser extent, bipolar disorder. Over a dozen such medications exist, and many are also available in generic form.
But for reasons that scientists can’t yet adequately explain, some people don’t respond to many antidepressant drugs. And the drugs they do respond to may carry unwanted side effects that make taking the drug for any length of time downright challenging.
So drug companies are constantly looking for new drugs, new uses for old drugs, and new formulations of old drugs to help improve their batting average. Sadly for this effort, though, we can cross off another potential drug — Nuvigil (armodafinil).
Nuvigil (armodafinil) is an already-existing and FDA-approved drug for the treatment of “excessive sleepiness” due to narcolepsy, shift work, or obstructive sleep apnea. Its not an antidepressant in any traditional sense. Instead it’s something like a stimulant or a “wakefulness-promoting agent.” ((Like its cousin, modafinil, Nuvigil is already prescribed for many of the same reasons — to promote wakefulness in people who are fatigued, can’t concentrate, or feel lethargic.))
Since sleep problems and lethargy are common complaints of people with depressive symptoms, its manufacturer was trying to get an add-on approved treatment for depression symptoms in bipolar I disorder.
The news was released yesterday by the drug’s researchers at Teva Pharmaceuticals. Nuvigil’s final Phase III studies showed statistical significance in “several important secondary endpoints” (which is drug-speak for “the massaged data show some significance, but clinically, you’d be hard pressed to find any benefit”). But it failed to show it was any better than a placebo or sugar pill.
Which is a pretty big deal. In the past few years, drug companies have been called on the carpet for designing studies that underestimate the impact of placebo versus medications (or otherwise cloud the results to minimize placebo data).
Because, as it turns out, the “placebo effect” — being treated with an inactive ingredient — is a pretty big thing in depression. The amount of professional care one receives as well as the simple belief that this pill will help change one’s mood, well, seems to work for some. They get better while taking the placebo.
And as Teva found out, they got better in this study at roughly the same rates as those who were taking the actual medication.
“While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system,” said Michael Hayden, Teva’s president of global R&D.
Nuvigil was likely not going to be a blockbuster anyway, because it was an “add on” drug for the treatment of major depression associated with bipolar I disorder. This is a serious area of concern, but it is not an especially large market.
Furthermore, psychiatrists can already prescribe Nuvigil for depressive symptoms associated with bipolar I disorder as an off-label use. So while not shown to be particularly effective, a psychiatrist can still give it a try if warranted.
Read the news release: Teva Reports Top-Line Results from Final Phase III Study of Armodafinil (NUVIGIL®) in Patients with Major Depression Associated with Bipolar I Disorder
11 comments
I would be interested if anyone could tell me the difference between Armodafinil and Modafinil from a personal experience? THanks
My doctor (psychiatrist) gave me a sample of Nuvigil (7 pills). I have tried just about everything for PTSD, depression and chronic insomnia. Nuvigil within hours made me feel wonderful. I also have had a sleep test done to see if I had sleep apnea and various other medical tests, lab work and everything comes back normal. So because I don’t fit the parameters for what Nuvigil can be prescribed for I can not get my insurance to cover and the drug is costly. I am extremely disappointed!
I had a similar problem getting Medicaid to pay.My pdoc did some research and found a covered dx that would fit my symptoms.It is so expensive you have to get creative.
To whom it may concern and to overly educated “so called” physcians,
I would be very surprised if the pockets of well known authors/ physcians weren’t lined by mega health insurance companies to keep the medication experimental! This helps insurance companies save billions of dollars a year at the suffering, cost of many people who get denied daily on a proven life saver in many cases.
To the “so called “well educated”, who are really ‘ignorant’, THINK BEYOND YOURSELVES!
God forbid people and drs. get to choose what works best. Insurance companies are so much more informed about what works. Of course, there’s no marketing or skewed results ever used to help insurance determine what will or won’t be covered. If you can try one of these (there are one month free coupons for nuvigil) and it works, odd work hours will usually get coverage. Even if I didn’t have split shifts, I’d say I worked some nights to get this med. It’s worth it to me.
Nuvigil was prescribed for my delayed sleep phase problems. I am bipolar 2. I had no preconceived ideas thatthis med would do anything other than help regulate my sleep. Three years later it is still controlling my mood disorder and depression. I’m lucky to work strange hours because otherwise ins. wouldn’t cover it. I don’t know about provigil but if it’s as good for mood disorders, those who have these disorders should get creative so ins. will cover a med that works. As for the placebo effect, that onlyworks if the subject thinks the med is for whatever issue is on the table. That means that there is no possible placebo effect because I was using it for staying awake, not mood issues. Placebo, schlamebo
I am diagnosed Borderline Personality Disorder, dysthymia, and Major Depressive Disorder. I have been on every kind of anti-depressant and cocktail, and nuvigil is what is working to get me up and going. I am on parnate to stop the suicidal urges and gabapentin for pain and it helps quiet the incessant negative thoughts.
So, definitely working, not placebo, because one day I took a zyrtec thinking it was my nuvigil (they look the same) and I was not good.
So, maybe not bipolar, but for treatment resistant depression/borderline, it is good stuff.
Nuvigil is actually used to stay active in daytime. It controls your sleep and makes you fresh to work during office hours. As I am working and I had sleep disorder. Due to sleep issues I used to sleep into the office and every time I became lazy. It had bad impact on my work. Due to this I just consult with my physician and he consult that I am suffering from sleep apnea. So based on my problem he suggests me to take nuvigil dosages which are mainly used to control sleep and keep you active. So today I am under this medication process which gives me better relief in my life.
Just recently started lower dose of Nuvigil. It works. I still have depression symptoms but I can get out of bed and take care of business. Without this medication everything I do is so much effort. So it may not treat all depression symptoms but definitely hellps for fatigue, cognition and to a lesser extent memory.
Maybe if the author of the article actually did clinical work and talked to patients, he would find what is being shared in this article. It DOES work in a myriad of ways for depression and it’s accompanying issues of fatigue, low motivation, et. al., that result from sleep disturbance associated with it. There are too many people who do the bidding of insurance companies that keep these meds out of reach of the people who really need it and who’s lives change because of them.
At age 60, a psychiatrist prescribed Nuvigil for me after 25 years of treatment resistant depression and all the meds, ect, tms etc. Within 1 hour of taking it (and very skeptical) I actually giggled at something on TV. I was startled, as it had been so long since that had happened. I can’t say enough about the ways Nuvigil saved my life – peace of mind, pleasure, contentment, renewed passion for my husband, hobbies, social life, etc. I’d forgotten how wonderful life can be. And no side effects! I had my life back. Long story short – I need to have it increased as time goes on. Now, 2 years later I’m going back to where I was because 250mg, which is the recommended dose for narcolepsy isn’t enough. I’ve contacted the drug companies but they are’t interested in helping people like me – BECAUSE THERE’S NOT A BIG ENOUGH MARKET TO MAKE THE MONEY FOR THEM!!! My psychiatrist prescribed more because he’d seen what I’d been through, but he won’t go any higher due to the greed and lack of compassion of the drug companies. This is a sin. I had my life back and now I just want to die rather than exist as before. I probably won’t be around long enough for this to change. PLEASE, someone listen before it;s too late for me and the others who can attest to this. I swear by Nuvigil – no more depression or anxiety. Is that too much to ask?