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.

Consumer Reports has published a valuable article identifying common prescription drugs that can be dangerous for older patients. Healthcare consumers over age 65 are more than twice as likely to suffer from adverse drug reactions; the publication lists the following drugs as posing a high enough risk that they should be avoided if possible:

• Antianxiety drugs

  Chlordiazepoxide (Librium, Limbitrol); diazepam (Valium); quazepam (Doral)

  Recommended alternatives: alprazolam (Xanax), lorazepam (Ativan), and oxazepam (Serax)

• Antidepressants

  Amitriptyline, doxepin (Sinequan) and Fluoxetine (Prozac)

  Recommended alternatives: citalopram (Celexa), paroxetine (Paxil), and sertraline (Zoloft)

• Antihistamines

  Chlorpheniramine (Chlor-Trimeton); diphenhydramine (Benadryl)

  Recommended alternatives: Cetirizine (Zyrtec); fexofenadine (Allegra); loratadine (Claritin)

• High blood pressure and enlarged prostate drugs

  Doxazosin (Cardura); prazosin (Minipress); terazosin (Hytrin)

  Recommended alternatives: Diuretics for high blood pressure; tamsulosin (Flomax) for enlarged prostate.

• Pain relievers

  Naproxen (Aleve, Naprosyn); oxaprozin (Daypro); piroxicam (Feldene); Meperidine (Demerol)

  Recommended alternatives: acetaminophen (Tylenol); ibuprofen (Advil ); capsaicin cream (Zostrix); morphine

• Sleeping pills

  Barbituates (Butisol, Nembutal, Seconal); diphenhydramine (Sominex); flurazepam (Dalmane)

  Recommended alternatives: zaleplon (Sonata) and zolpidem (Ambien)

• Stomach drugs

  Bisacodyl (Dulcolax); Diphenoxylate (Lomotil)

  Recommended alternatives: Increased intake of fiber and fluids; change in diet; loperamide (Imodium AD)

Specifically, the Consumerist says that “suffix drugs” — the kinds with letters like CD, CR, ER, LA, SR, XL, XR, or XT after the name — are usually just different versions of the same drug that vary only in how the drug releases in the body. The blog then says:

By coming up with different variations on old drugs, pharmaceutical companies can keep the profits rolling on drugs whose patents have expired. Best of all, if they can get the doctor to write one of these letter sequences after the drug’s name, the pharmacy can’t substitute a lower-priced generic (unless a generic of the extended release version is already on the market).

For example, Wellbutrin (bupropion) came out in 1985 requiring 3 pills a day. In 1996, 36 months before the old patent expired, they came up with Wellbutrin SR, only 2 pills a day. In 2003, 5 months before the SR patent expired, Wellbutrin XL was released, only one pill a day.

A 3 month supply of 300 mg of bupropion per day retails on average for $270. You’ll have to pay $693 and $656 for Wellbutrin SR and XL, respectively. Over the course of a year, that’s $1080 extra dollars. Is it really worth paying 2.5 times as much just for one fewer pill?

You know how we feel about Big Pharma’s slimy game-playing with patents, so you know where we stand on this issue; we agree, in principle, with the Consumerist and Dr. Jardini.

But every drug is different — as is every patient’s reaction. The Consumerist handled the issue too glibly, causing it to receive quite a bit of pushback from its commenters. In fact, we found the pushback just as valuable as the blog post itself.

Here are a few choice responses:

Wellbutrin can cause seizures if too high of a dose is given at once. The time release capsules allow a higher dose to be taken because it will be slowly released into your blood stream rather than released all at once (which is what brings on the seizures). For people not at risk for seizures, or for people taking low doses, the SR or XL probably doesn’t matter, but for some people it does…

I take Adderall XR. When I was first prescribed adderall, i was on lower doses, multiple pills per day. There were definite peaks and valleys to my day. At one point I was also on generics, which gave me a headache, so i went back to regular adderall. I then switched to the XR to try and avoid peaks and valleys and I haven’t looked back since. It’s not just as simple as fewer pills, the body chemistry is different, that’s why its a different prescription…

I prefer the Ambien CR. Because with regular Ambien I wake up in less than 5 hours. With CR I can get a full 8 hours…

Totally bad advice. I take the Wellbutrin XL, and have since its release. Prior to that, on the Twice a day SR, I would frequently forget – and suffer the consequences. Anti-depressants are less forgiving than other medications. The time release aspect of the XL really reduces the swings even normal doses of SR can cause…

When an epileptic stops taking his extended release medication because the Consumerist told him the evil pharm companies were ripping him off, don’t be surprised when he hires a lawyer. The consumerist should leave the job of dispensing medical advice to those with medical degrees…

Really, there are two separate issues here. First, choice is good for consumers; the more versions of a drug the better. And clearly from the comments above, those little suffixes can and do make a difference.

The second issue is not really a medical issue; it’s a public policy issue. Why do these different drugs have such different costs? The answer is clearly that Big Pharma is taking advantage of our current drug patenting system’s loopholes; as one commenter correctly puts it:

Remember, the drug companies could have offered all the versions at once, but by delaying releases till patent protection is near expiration helps them control the market for many times longer than traditional patent protection would provide.

This is plainly true. And we, as consumers and members of the public in a democracy, have the power to close these loopholes. We can require the FDA to be stricter in its patent requirements. By not doing so, we’ve effectively allowed pharmaceutical companies to keep new versions of a drug off the market simply in order to extend their patents and avoid generic competition.

The (understandable) mistake the Consumerist has made here is underestimating how completely the tentacles of Big Pharma control our behavior as drug consumers — and how difficult it is for us to extract ourselves from their grasp.

By the way, eDrugSearch.com’s own e-book on saving money on prescription drugs will be coming out soon. Be on the lookout.

1. MARILYN MONROE. Elton John’s “Candle in the Wind” died from an overdose of sleeping pills — specifically, Nembutal and chloral hydrate [pictured]. Although Monroe’s death was officially listed as a suicide in 1962, many forensic experts and investigators now say the overdose was more likely to have been accidental.

2. ELVIS PRESLEY. Perhaps the most famous prescription-drug abuser of all time, Elvis died in 1977 from an overdose of medications while on the toilet in his Graceland mansion. Presley’s ex-wife wrote: “Presley was taking Placidyls [pictured] to combat severe insomnia in ever increasing doses and later took Dexedrine to counter the sleeping pills’ after effects.” Presley’s personal physician, Dr. George C. Nichopoulos, concluded: “Elvis’s problem was that he didn’t see the wrong in it. He felt that by getting [pills] from a doctor, he wasn’t the common everyday junkie…”

3. JUDY GARLAND. The Wizard of Oz star was found dead in her London bathroom by her husband in 1969. Coroner Gavin Thursdon said the cause of death was an accidental overdose of Seconal [pictured].

4. HOWARD HUGHES. The germophobic genius and subject of Martin Scorcese’s The Aviator died in 1976 in route to a Houston hospital from his Acalpulco estate. Although the official cause of death was liver failure, his autopsy showed lethal amounts of codeine and valium [pictured] in his system.

5. ANNA NICOLE SMITH. According to Wikipedia, “Ultimately her death [in 2007] was ruled an accidental drug overdose of the sedative chloral hydrate that became increasingly lethal when combined with other prescription drugs in her system, specifically 4 benzodiazepines: Klonopin (Clonazepam), Ativan (Lorazepam), Serax (Oxazepam), and Valium (Diazepam). Furthermore, she had taken Benadryl (Diphenhydramine) and Topamax (Toprimate), an anticonvulsant GABA agonist, which likely contributed to the sedative effect of chloral hydrate and the benzodiazepines.”

6. DOROTHY DANDRIDGE. The first African-American actress to be nominated for an Academy Award, Dandridge was found dead in West Hollywood in 1965 from an overdose of Imipramine [pictured], a tricyclic antidepressant. It’s believed she improperly combined the medication — which she took for her bipolar disorder — with pain medication she received after breaking an ankle.

7. DANA PLATO. The long-troubled Diff’rent Strokes star died from an accidental overdose of Vanadom [pictured] and Vicodin at her mother-in-law’s Oklahoma home in 1999.

8. KEITH MOON. The Who drummer died in 1978 from an accidental overdose of Heminevrin [pictured], a medication taken as part of a program to wean him off alcohol.

9. ROB PILATUS. The Milli Vanilli star, disgraced after the public learned the music duo did not actually sing on its hit records, died in 1998 of an accidental overdose of a medication (reportedly methadone [pictured]) designed to help him with drug withdrawal symptons.

10. ROBERT WALKER. Perhaps the most bizarre accidental prescription-drug death. The star of Hitchcock’s Strangers on a Train died mysteriously in 1951 after being given an injection of the “truth serum” sodium amytal [pictured] by psychiatrists at his home.

11. NICK DRAKE. The influential singer-songwriter died at his childhood home in the U.K. in 1974 from an accidental overdose of the antidepressant amitriptyline [pictured].

12. PAIGE SUMMERS. The 1998 Penthouse Pet of the Year was found dead in her fiance’s home in 2003 from a combination of the painkillers codeine and oxycodone. Her death may or may not have been an accident; some have pointed a finger at fiance Bracey Bobbitt — who was a pharmacist.

Four of the world’s biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines.

The four companies behind the idea — Johnson & Johnson, Pfizer, Novartis and Procter & Gamble — claim that this would be a good way to enlighten patients, a.k.a another good way to market their products. The most telling excerpt from the article:

The industry has been lobbying in Europe to be allowed direct access to patients. It argues that lifting restrictions would help its competitiveness and has hinted that companies may relocate to the US, where they can advertise to patients who then demand drugs from their doctors. Profits have soared there as a result.

If you can’t get your way, just go to America; they’ll do anything for drug companies there.

Hat Tip: PharmaGossip

The Food and Drug Administration said … that regulators had approved generic versions of Ambien, a blockbuster sleeping pill from Sanofi-Aventis. The drug, also known as zolpidem tartrate, has been linked to potential risks like driving while asleep and allergic reactions. Like Ambien and other popular sleep drugs, the new generics will also have to carry warnings on their product labels, the agency said.

Manufacturers cleared to make generic versions include Mylan Laboratories, Teva Pharmaceutical Industries, Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Apotex and Synthon Pharmaceuticals. Genpharm, Mutual Pharmaceutical, Caraco Pharmaceutical Laboratories, Carlsbad Technology and Lek Pharmaceutical also won agency approval. The generic makers will sell the drug, approved to treat short-term bouts of insomnia, in 5-milligram and 10-milligram doses.

A spokeswoman for Sanofi, Emmy Tsui, said the drug maker would continue to sell Ambien as well as its extended release version, Ambien CR, which is also approved to help people stay asleep.

The US Food and Drug Administration (FDA) has issued a warning to consumers about placing orders for prescription drugs over the Internet, saying that recent cases have shown that what was delivered is not what was ordered and is putting people in hospital. In a release, the FDA said it has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug…

The FDA said laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia. FDA learned about the mislabeled and potentially dangerous products after their recipients complained to a US pharmaceutical manufacturer. The origin of the tablets is unknown but the packages were postmarked in Greece.

Here we go again: the FDA using the actions of a few rogue players to issue a broad-brush warning about Internet pharmacies. This is nothing new; the FDA is clearly in the pocket of Big Pharma and does its bidding at every turn.

Were the actions of these rogue pharmacies inexcusable? Absolutely. Does this have anything to do with licensed international pharmacies with verifiable third-party accreditations? No — absolutely not.

Would the FDA warn American consumers to not shop at the corner Walgreens because of what happened in San Antonio recently? No — in fact, they do very little to inform the consumer in such cases.

At eDrugSearch.com, we believe the best way to empower the consumer is to provide you with the information you need to make good decisions. And that includes making sure you know that we only allow safe, licensed pharmacies in our database.

As for the FDA’s agenda? We’re reminded of what Merrill Goozner told us in our recent chat with him:

I always find it curious that free traders are worried about the safety of drugs imported from Canada, but not lettuce from Mexico. I suspect Canada’s system for protecting its consumers against unsafe drugs is far superior to Mexico’s system for protecting consumers against contaminated food.

Makes you wonder, doesn’t it?