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Many of my therapist colleagues complain that it is difficult to know about and/or understand new drug releases before their clients. The Internet gives patients access to good and erroneous information about pharmaceuticals often before their FDA approvals. Patients then expect their therapists to render informed opinions about these drugs. To this end, we will periodically review new entries in the marketplace so that our opinions will appear "informed." Antidepressants Cymbalta and Pexeva represent the newest antidepressant entries. Pexeva is an alternative to generic paroxetine (Paxil) with a slightly different formulation of the active ingredient. Its selling point is that it is priced between generic and branded Paxil for patients who cannot tolerate the generic. Cymbalta is a facilitator of serotonin and norepinephrine transport in the brain. It has been found to be an effective antidepressant with the suggestion of lower sexual side effects in many patients, especially females. It may help with physical symptoms of depression such as pain. It is FDA approved for diabetic peripheral neuropathy pain and is used off label for a variety of painful syndromes such as fibromyalgia, headaches and pinched nerves in the back or neck. Nausea is the main side effect. A new technology, implantable vagus nerve stimulators, is seeking to add a surgical alternative to antidepressants. This will be discussed in a future column. Antianxiety/Sleep Aids In the antianxiety arena, the focus has been on taking older drugs and marrying them to different delivery systems that would allow for quicker performance. Thus we have two older compounds, alprazolam (Xanax) and clonazepam (Klonopin) that were placed in orally dissolvable wafers for more rapid onset of action. Niravam is the alprazolam wafer and Klonopin wafers speak for themselves. These drugs are particularly helpful in anxiety or panic situations where water is not available —such as rush hour in a car—as they dissolve on the tongue. Niravam is more short acting (4-6 hours) than Klonopin wafers (6-8 hours). Sedation or short-term memory difficulties can be side effects. Lunesta is a drug that is designed for sedation, as it is a sleeping pill. It is designed for long-term usage whereas the other sleeping pills are FDA approved for shorter terms of usage (though they are also used off label for longer periods of time). Feeling drowsy in the morning after usage is the most common side effect. ADHD Again the focus here is on a new delivery system for an older drug. Focalin has existed for several years as a "chirally switched" form of methylphenidate (active ingredient in Ritalin). This means that it possessed the active molecule (isomer) of methylphenidate without the inactive molecule that was therapeutically inert. The thinking here was that a more "purified" molecule would be more effective at a lower dosage with less side effects. Focalin, however, would only work for 2-4 hours and was never popular due to the need for multiple daily doses. Focalin XR is the "new" focalin with a sustained release delivery system that allows it to work for 8-10 hours on average, leading to one dose per day. Provigil is also pursuing FDA approval at the time of this writing for ADHD. Several studies have indicated that a metabolite of Provigil may be effective for ADHD at higher dosages (300mg/ day). The new drug was supposed to be called Attenace, but the FDA has asked for a different name if approved. It will represent another non-stimulant alternative for ADHD. Provigil is currently indicated for excessive daytime sedation from narcolepsy, sleep apnea or shift work disorder. Alcoholism A truly new drug is Campral, which is FDA approved for alcoholism treatment. It is the only drug that seeks to decrease the desire to drink by decreasing craving. Antabuse would make you sick if you drank. Revia (naltrexone) would block the euphoric effects of drinking (i.e.—no buzz). This drug seeks to keep the patient from drinking in the first place. Its effects are complicated, but seem to revolve around several neurotransmitters, especially glutamate. It has been well tolerated so far. _Michael R. Lyles, M.D., is an AACC Executive Board Member and is in private practice with Lyles & Crawford Clinical Consulting in Roswell, Georgia._
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