Long-term sufferers of insomnia who have not found lasting relief from such sleep aids as Ambien or Sonata should consider researching Rozerem, the only medication of its type approved in the treatment of sleeplessness.

Rozerem (ramelteon) is the first of a new class of insomnia drugs: melatonin receptor agonists. These are similar to the naturally-produced sleep hormone melatonin, which your body needs for healthy sleep cycles. Rozerem, manufactured by Takeda Industries North America, was approved by the FDA in July 2005 for the treatment of delayed-onset insomnia. It emerged against a backdrop of other classes of drugs to treat the condition — and it has some important differences.

Insomnia was historically treated with barbiturates, which were extremely strong and frighteningly addictive. In the Sixties, the benzodiazepines appeared. These drugs (such as Halcion) helped treat insomnia with a much lower rate of serious side effects and addiction, but still had moderate side effects such as dizziness and a hangover effect. In the Nineties, there emerged a new class of non-benzodiazepine sleep aids, including Sonata and Lunesta, which have safely helped many people combat insomnia. Still, as they target several broad areas of the brain that are involved in sleep, they still have considerable side effects on memory and clarity.

In 2005, Rozerem was approved as a treatment for insomnia. It is said to have a different, more precise mechanism than other sleep aids, with an ability to target the “master clock” of the human body, affecting the sleep-wake cycle without unduly interfering with nearby brain functions.

Because it is in a different class than Lunesta and Ambien, Rozerem may be an effective treatment for patients who have not found lasting results on these medications. If you have not reconsidered your insomnia treatment since this important new class of drugs appeared in 2005, it is worth researching these new developments, as they may cure your insomnia more effectively, or do so with fewer side effects.

Side effects: Common side effects on this medication are dizziness, drowsiness, and daytime sleepiness. Sometimes people using this drug sleep-walk or perform other actions in their sleep. More serious side effects involve hormonal changes such as missed periods, nipple discharge, or difficulty becoming pregnant. It is important to tell your doctor immediately if you experience depressed or suicidal thoughts while taking this medication. Finally, be aware of any symptoms of a very serious allergic reaction to Rozerem such as a rash or swelling. Call your doctor immediately if this occurs.

Cautions and contra-indications: Rozerem is not suitable for patients with liver disease. You should not take it if you are also taking fluvoxamine, rifampin, or certain antifungal antibiotics. You should advise your doctor if you suffer from any breathing disorders such as sleep apnea or chronic obstructive pulmonary disease. You should also tell your doctor if you have a history of mental illness, depression, or suicidal thinking. And of these factors might mean that you cannot take Rozerem, or that you might have an adjusted dose. Rozerem is a pregnancy category C drug, so it may be harmful to an unborn baby, or in breast milk. Finally, Rozerem may affect hormonal levels in men and women, with possible effects to the desire and fertility. Talk with your doctor about your reproductive plans if you are considering Rozerem.

As with any drug, please consult your doctor before taking.

Reports have surfaced that pop superstar Michael Jackson was spending as much as $48,000 per month on prescription drugs, including Demerol and Diprivan.

A sidelight of this story is the pharmacy that news reports say filled and delivered many of those orders: Mickey Fine Pharmacy & Grill in Beverly Hills.

Mickey Fine is a pretty snazzy-looking place. It was originally one of those legendary Schwab Pharmacies where starlets were discovered while drinking milkshakes. As recently as March, it was a featured location in the Starz comedy series “Head Case.”

It’s not the kind of place you would normally associate with supplying a prescription drug habit.

Let me be clear: there is absolutely no evidence that Mickey Fine has done anything wrong here. But I hope its involvement in the Michael Jackson case will help us to think twice about preconceptions and stereotypes when it comes to prescription drug abuse.

Opponents of American citizens buying drugs from Canada have worked hard to associate online pharmacies with the increase in prescription drug abuse — although there is absolutely not one shred of statistical evidence to support this claim.

The fact is, while it’s certainly possible to use online pharmacies to feed a drug habit, it’s just as easy to borrow medications from friends, sneak them out of your parents’ medicine cabinet — or to get prescriptions from multiple doctors and fill them at a place like Mickey Fine.

Researchers from the University of Chicago Medical Center report in the Dec. 24/31, 2008 issue of JAMA that more than half of older Americans take five or more prescription medications — and that an alarming number of these seniors risk harmful drug interactions.

We’ve warned of drug interactions here before — and have recommended sites like DoubleCheckMD.com to make sure your drug regimen is safe.  This latest study reinforces the importance of such precautions.

According to the researchers, at least one in 25 older adults take multiple drugs in combinations that can produce a harmful drug interaction.  That’s 2.2 million seniors in the United States.

Nearly half of the drug interactions identified in the study put seniors at risk for bleeding problems. One of the most common was taking warfarin, a medication to prevent blood clots, along with an over-the-counter drug such as aspirin, which also interferes with clotting.

One of the issues the report raises is the importance of being aware of potential drug interactions; be sure to talk with your doctor and pharmacist, and to use online tools like DoubleCheckMD, to ensure that your drug regimen is safe.

AttorneyatLaw.com reports that Wikipedia entries on prescription drugs “may exclude important information about life-threatening side effects and drug interactions,” according to researchers from Nova Southeastern University in Palm Beach Gardens, Florida.

As you know, we at eDrugSearch.com are all about healthcare consumers empowering themselves by learning about drugs online. We think our online pharmacy dictionary is an excellent source for this information, because it is comprised of data from sources like the FDA and, for breaking news updates, the Associated Press. In addition to our online pharmacy dictionary, there are a number of other good sources out there as well.

Unfortunately, Google is in love with Wikipedia — which means that when you search for many prescription drug names, the Wikipedia entry is one of the first selections that will pop up in your browser. Please, resist the urge to base any medical decisions on information on Wikipedia; use it only as a starting point for further research — both online and in consultation with your doctor or pharmacist.

From the Wall Street Journal Law Blog:

After the arguments wrapped up in Wyeth v. Levine…we called around and spoke to a couple lawyers who were present at the scene. Based on those convos, and an AP report, we were able to cobble together an overview of the back-and-forthing…

…the Justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, said Justice Souter. “And it simply didn’t do it.”

But Seth Waxman, who argued the case for Wyeth, argued … that, when the FDA has specifically considered the risk involved and rejected the sort of warning that Diana Levine seeks, then the claim is preempted because it directly conflicts with the FDA’s own determination.

The plaintiffs, on the other hand, argue that the FDA regulations are merely a floor, not a ceiling, and that state tort law augments those regulations by providing companies with incentives to inform of all possible risks…

Indeed, when Justice Kennedy asked Levine’s lawyer when preemption should apply, the lawyer said that if the FDA had adequately weighed the risks and benefits … and included those details on the label, then his client wouldn’t have a case. However, the lawyer argued, those details weren’t provided. Therefore, preemption doesn’t exist in this case.

Sounds to me like the Levine argument is more than reasonable. She was awarded $6 million after having her arm amputated — which also sounds reasonable.

Why on earth would ANYONE favor government deregulation AND the de-fanging of our tort system? Without both of these protections, consumers are completely powerless when they are injured by the actions or negligence of large corporations.

Please, don’t buy into this nonsense about tort reform being about people who are awarded $100 million dollars for spilling hot coffee on themselves. That just doesn’t happen — and in the very rare instance when it does, the monetary award is always subsequently reduced or eliminated (even if this reduction doesn’t make the headlines.)

If you want to know how hard it is for people to collect money from large corporations or wealthy individuals who have wronged them, look at the Exxon Valdez case — or the O.J. Simpson civil case for that matter. Neither Exxon nor Simpson have paid a dime since those big-money judgments made the news.

The tort reform movement is funded by large corporations. They fund tort reform because they want to make more money, plain and simple. If you buy into it, you’re not reducing your costs — you’re just increasing their margins. You’re playing into their hands.

A decision on Wyeth v. Levine is expected this week. Kaiser has a great overview of the case here.

I came across a list of “rules” for safer prescription drug use by the non-profit consumer group Public Citizen, and found some useful ideas in it. I’ve summarized the tips in excerpts below. Go here for the full post.

1. Have “Brown Bag Sessions” with Your Primary Doctor.

Whenever you go to a doctor you have not previously seen or to one with whom you have never had a brown-bag session, gather all prescription and over-the-counter drugs and dietary supplements in your medicine cabinet or anywhere else and bring them to the doctor … Doctors should never prescribe a drug or renew a prescription, nor should you be willing to get a new prescription, without full, up-to-date knowledge of all drugs already being taken or likely to be taken.

2. Make Sure Drug Therapy Is Really Needed.

Often, drugs are prescribed to treat situational problems such as loneliness, isolation, and confusion. Whenever possible, nondrug approaches to these problems should be tried. These include hobbies, socializing with others, and getting out of the house. When a person is suffering from an understandable depression after losing a loved one, for example, support from friends, relatives, or a psychotherapist is often preferable to drugs such as antidepressants. Nondrug therapy, such as weight loss and exercise, is preferable to drug therapy for such problems as mild high blood pressure and mild adult-onset diabetes. Drugs should rarely be prescribed for anxiety or difficulty sleeping, particularly in older adults…

3. If Drug Therapy Is Indicated, in Most Cases, Especially in Older Adults, It Is Safer to Start with a Dose That Is Lower Than the Usual Adult Dose.

More generally, start with as low a dose as possible. In other words, “Start low, go slow.” A lower dose will cause fewer adverse effects, which are almost always related to dose. In the elderly, some experts suggest starting with one-third to one-half the usual adult dose for most drugs and watching for side effects, increasing the dose slowly and only if necessary to get the desired effect.

4. When Adding a New Drug, See If It Is Possible to Discontinue Another Drug.

If your doctor is considering adding a new drug, this is an opportunity to reevaluate existing drugs and eliminate those that are not absolutely essential. The possibility of an adverse drug interaction between the new drug and one of the old ones may lead to discontinuing or changing the use of a drug.

5. Stopping a Drug Is as Important as Starting It.

At least every three to six months, regularly review with your doctor the need to continue each drug being taken. For many mind-affecting drugs, such as sleeping pills, tranquilizers, and antidepressants, and for antibiotics, this reevaluation should be more frequent and sooner. The prevailing principle for doctors and patients should be to discontinue any drug unless it is essential. Many adverse drug reactions have been caused by continuing to use drugs long after they are needed.

6. Find Out If You Are Having Any Adverse Drug Reactions.

If you develop [adverse] reactions after beginning to use any drug, contact your doctor. Ask if you really need a drug in the first place and, if you do, whether a safer drug can be substituted or whether a lower dose could be used to reduce or eliminate the adverse effect.

7. Assume That Any New Symptom You Develop After Starting a New Drug May Be Caused by the Drug.

If you have a new symptom, report it to your doctor.

8. Before Leaving Your Doctor’s Office or Pharmacy, Make Sure the Instructions for Taking Your Medicine Are Clear to You and a Family Member or Friend.

Regardless of how old someone is, the chance of adverse reactions is high enough that at least one other person—a spouse, child, or friend—should know about these possibilities. In the presence of such adverse reactions as confusion and memory loss, this is especially critical … Ask your doctor to make sure that the label on the drug states, if at all possible, the purpose for which the drug is being used. This is especially important when you are using multiple drugs but is always important as a way of increasing your and your family’s or friend’s participation.

9. Discard All Old Drugs Carefully.

Many people are tempted to keep and reuse drugs obtained in the past, even though their condition has changed. Additional drugs used may make the earlier drugs much more dangerous. In addition, you may be tempted to give drugs, such as antibiotics, to a friend or relative who you believe may benefit from them. Resist these temptations and avoid further problems caused by using outdated drugs by throwing them away when you are done with your course of therapy.

10. Ask Your Primary Doctor to Coordinate Your Care and Drug Use.

If you see a specialist and he or she wants to start you on new medicines in addition to the ones you are on, check with your primary doctor first—usually an internist or general or family practitioner. It is equally important to use one pharmacist, if possible.

Watch this informative video from Craig Svensson, dean of Purdue’s College of Pharmacy, Nursing, and Health Sciences, explaining why medication errors are so common and offering solutions for preventing them.

That’s dangerous — and in a world where many of us don’t have long-term relationships with a single doctor or pharmacy, it’s becoming all too common for us to fall into drug regimens where the individual medications either counter each other’s effects or create unexpected, and sometimes even deadly, side effects.

That’s why Health 2.0 sites like DoubleCheckMD and PharmaSurveyor are so valuable; they allow you to enter medications and research possible interactions yourself.

If you don’t want to take the do-it-yourself route, however, the Houston Chronicle recommends the following precautions:

Heidi Bragg, a pharmacist and University of Houston School of Pharmacy professor …recommends two actions to help take control of your own health: keep a list of every prescription, supplement and over-the-counter medicine you take, and use one pharmacy to fill all your prescriptions.

The pharmacy professor said drug interactions are especially significant for elderly patients who often take more medicines.

Bragg said she met with one woman who took four synthetic thyroid medications at one time all prescribed by different doctors, all different dosages and all filled at different pharmacies.

“She could have died,” Bragg said.

Pharmaceutical companies talk fast in commercials when they warn about drug interactions. But for your health’s sake, it’s in your interest to take your time and make sure your regimen is both safe and effective.