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Topamax to treat alcohol dependence

Last updated: September 2010

Almost a third of Americans consume enough beer, wine, or other liquor to be considered "problem drinkers"—meaning they're at risk of becoming alcohol dependent, according to a 2005 study in the American Family Physician journal. That final stage, also known as alcoholism, affects up to 12 percent of the population. The National Institute on Alcohol Abuse and Alcoholism (NIAA) says that symptoms include:

  • A craving for alcohol
  • An inability to stop drinking once it has begun
  • Nausea, sweating, shakiness, restlessness, or anxiety after drinking has stopped
  • The need to drink greater amounts of alcohol to feel "high"

Counseling and 12-step programs have been the mainstays of treatment for alcohol dependence. But medication has assumed an increasingly important role. The Food and Drug Administration has approved three drugs for that purpose: disulfiram (Antabuse and generic), naltrexone (ReVia, Vivitrol, and generic), and acamprosate (Campral). But most studies on their effectiveness have required patients to abstain from drinking before starting the medication. In contrast is topiramate (Topamax and generic), a drug that has been successful in treating volunteers who were still drinking heavily, according to a new analysis by the American Society of Health-Systems Pharmacists. But unlike the other medications, topiramate is not FDA-approved (also called "off-label" prescribing) to treat alcohol dependence.

Available as a tablet or capsule, topiramate is approved to treat certain types of seizures and prevent migraine headaches. It's used off-label to combat alcoholism because in addition to other effects, it appears to correct a chemical imbalance in the brain caused by chronic drinking including a decrease in "rewarding" effects in the brain from continued consumption.

"The advantages of topiramate are that it works well and can be used in people who are actively drinking," says Henry R. Kranzler, M.D., associate scientific director of the Alcohol Research Center at the University of Connecticut. "But it causes troublesome side effects, especially memory and thinking problems and sedation. To minimize them, the dosage must be increased slowly over as long as eight weeks, which requires multiple doctor visits and means patients may not achieve results as quickly as they would with another medication."

How well does topiramate work to treat alcohol dependence?

In two double-blind, randomized, placebo-controlled trials, topiramate decreased drinking and increased abstinence in alcohol-dependent adults. In one of the studies it also reduced alcohol craving, and in additional analyses it improved patients' quality of life as well as their blood pressure, liver-enzyme, and cholesterol levels, which often increase with excessive drinking. But since the original studies were conducted only for 12 to 14 weeks, the long-term effectiveness of the drug could not be determined. Moreover, the trials were fully or partly funded by the manufacturer of Topamax.

In another study, Spanish researchers randomly assigned alcohol-dependent patients to treatment with either topiramate or naltrexone for six months. The patients were not "blinded," meaning they knew which medication they were taking. Both groups showed substantially less drinking, but topiramate proved to be better at reducing craving. And in a small observational study, also from Spain, alcoholic patients who had responded poorly to standard treatment were given topiramate, which reduced drinking and craving.

While those results are promising, longer-term trials are needed to determine which patients would benefit from topiramate, as well as the optimal dosing and duration of treatment. Many clinical trials are in progress to learn more about the role of topiramate in treating alcohol dependence.

In addition to medication therapy, professional counseling has been found to be particularly effective in the early phase of recovery.

What are the risks with topiramate in treating alcohol dependence?

Side effects reported in studies on alcohol dependence include tingling in the extremities, memory and thinking problems, weight loss, fatigue, insomnia, diarrhea, changes in the ability to taste food, and itching. Here are some additional risks and suggestions about how to minimize them:

Decreased sweating. Topiramate can make it more difficult for your body to cool down when it gets very hot. Avoid exposure to heat, drink plenty of fluids, and tell your doctor if you have decreased sweating or increased body temperature.

Eye problems. In rare cases, nearsightedness and glaucoma—a blockage of fluid that causes increased pressure in the eye—were also reported but resolved with discontinuation of the drug. Tell your doctor if you've ever had glaucoma, and report any sudden decrease in vision, eye pain, or redness while taking the drug.

Confusion, difficulty concentrating, dizziness, and drowsiness. Don't drive a car or operate machinery until you know how it affects you.

Drug interactions. Topiramate interacts with many drugs and can decrease the effectiveness of birth-control pills. Tell your doctor what prescription and over-the-counter medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Kidney stones. Drink six to eight glasses of water a day to reduce your chances of getting these, which can be excruciatingly painful.

Too much acid in the blood (acidosis). This is more likely if you have kidney disease, respiratory problems, or diarrhea, or if you consume a high-fat, low-carbohydrate diet. Tell your doctor if you have any of those conditions before or during treatment, and don't follow a high-fat, low-carb diet while taking the medication. Your doctor should do a blood test before treatment and then periodically during treatment to monitor your body's acid balance.

Suicide. Topiramate might increase the risk of becoming suicidal. Call your doctor right away if you experience panic attacks, anxiety, depression, sleep problems, aggression, preoccupying thoughts about death, or any other unusual changes in behavior or mood.

In addition to the conditions specified above, tell your doctor if you've ever had liver problems, osteoporosis, or mood disorders, or if you are pregnant, planning to become pregnant, or breast-feeding.

Don't stop taking topiramate without first talking to a doctor. Suddenly discontinuing the drug can cause serious problems.

Bottom line. Topiramate is one of several drugs currently recommended in national and international guidelines for the treatment of alcohol dependence. But further studies are needed to determine its long-term safety, efficacy, and potential role in the treatment of alcoholism. Our advice: Talk with your doctor about all available treatments for your condition, including counseling, 12-step programs, the management of withdrawal symptoms, and medication for dependence. If approved medications aren’t effective or you can’t tolerate them, or if you are unable to abstain from alcohol during treatment, consider topiramate after its risks and benefits have been thoroughly explained to you. The NIAAA publishes a useful guide to each of the medications. You should know, too, that you might respond better to one type of treatment than another.

For referrals to treatment specialists and programs, contact:

This off-label drug use report is made possible through a collaboration between Consumer Reports Best Buy Drugs and the American Society of Health-System Pharmacists. This is the15th in a series based on professional reports prepared by ASHP.

These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
   

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