What a difference a couple of years make. In 2004 or so I tried Provigil, but it greatly aggrevated my spasms. Last year, as I was complaining to the same doctor who had given me Provigil four years earlier, of how tired the meds were making me and he suggested that I give it another shot. And it hasn't aggrevated the RSD/CRPS a bit, but then, for me, neither does coffee.

BUT, a few months ago, around the time I was bumped up to Methadone* by my pm doc and not even Provigil wasn't cutting the mustard, so my shrink suggested that I try a varient of the molecule by the same manufacturer (and I don't believe its patent is set to expire anytime soon, but I may be wrong) this one called Nuvigil (armodafinil). It worked wonderfully, the only problem was that a month later, both ends of my blood pressure had jumped 30 points. I stopped taking it at once (the only new drug in a long time) and the BP went back to normal: using a very slick home health monitor that wasn't terribly expensive, all things considering. Then, as an experiment, I took one more pill a few days later and up again everything went. The physician's insert (which someone intentionally made impossible to block and copy) mentions that:

Blood pressure monitoring in short-term (≤ 3 months) controlled trials showed only small average increases in mean systolic and diastolic blood pressure in patients resceiving NUVIGIL as compared to placebo (1.2 to 4.3 mmHg in the various experimental groups). There was also a slightly greater proportion of patients on NUVIGIL requiring new or increases use of anti hypertensive medications (2.9%) compared to patients on placebo (1.8%). [Only a 37.9% increase.] Increased monitoring of blood pressure may be appropriate in patients on Nuvigil.

http://www.nuvigil.com/media/Full_Pr...nformation.pdf

What's odd is that while I apparently tollerate Provigil, its prescribing information sheet has not only the same admonition regarding the monitoring of blood pressure, but even worse stats on the increased use of blood pressure meds, especially in patients with obstructive sleep apnea - which I've got - going from 1.1% with patients on placebos to a whopping 3.4 with Provigil, or an increase of 67.6%.

Finally, in a condensed form, here are the basic warnings for Nuvigil. Note that most if it is based on studies on modafinil (Provigil) but there's some scarrier stuff in there than a mere rise in BP although the "consolation" for me is that once you're on it for more than a few weeks, you're highly unlikely to get the potentially fatal rashes of which they speak, only thing is, they have yet to figure out who's at a greater risk going in:

Important Information for Physicians

Indications
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSA), shift work sleep disorder and narcolepsy.

In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice, the encouragement of and periodic assessment of CPAP compliance is necessary and a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is important. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

Important Safety Information
Warnings
Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients; these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). No serious skin rashes have been reported in adult clinical trials of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children taking modafinil in postmarketing experience. Although benign rashes occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated with NUVIGIL. Angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis.

Multi-organ hypersensitivity reactions, including at least 1 fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. If a multi-organ hypersensitivity reaction is suspected, NUVIGIL should be discontinued.

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Precautions
•Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that NUVIGIL therapy will not adversely affect their ability to engage in such activities.
•Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. NUVIGIL should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on NUVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on NUVIGIL.
•NUVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome P450 isoenzymes.
•The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.
•The concomitant use of NUVIGIL and alcohol has not been studied and should be avoided.

http://www.nuvigil.com/hcp/index.php

I've got to say, the last line about never studying its use with alcohol (which also appear in the Provigil literature) would crack me up if it wasn't for the fact that some people could conceivably become quite ill (or worse) because of what could be described as an extreme case of willful blindness on the part of Cephalon. It's like a judge once admonished me after I asked the opposing party/witness a question in a bench trial and got response that completely undercut one of my lines of attack: Never ask a question to which you don't know the answer!

Mike

*For me, an unmitigated disaster.