Stephanie Saul at the New York Times did a great article today, “Sleep Drugs Found Only Mildly Effective, but Wildly Popular” The article dispels the myths concerning the effectiveness of the expensive brand-name prescription sleep aids whose television ads blanket the airwaves every night, including Lunesta (made by Sepracor [NYSE:SEPR]), Ambien and Ambien CR (made by Sanofi Aventis [NYSE:SNY]) and Rozerem (made by Takeda Pharmaceuticals).

We made many of the same points as this article last year when we gave the makers of Lunesta and Ambien/Ambien CR one of our Bitter Pill Awards, specifically the While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep.

Some of the key points that the article made:

• American consumers spend $4.5 billion a year for sleep medications.
• As a group, Ambien, Lunesta and Sonata reduced the average time to go to sleep 12.8 minutes compared with fake pills (placebo), and increased total sleep time 11.4 minutes. Hardly results so impressive that they warrant $4.5 billion in annual spending.
• Two older drugs, Halcion and Restoril, caused people to fall asleep 10 minutes faster and slept 32 minutes longer than the placebo group.

So the newer drugs caused people to fall asleep a whopping 2.8 minutes faster than the older drugs, yet the older drugs increased sleep time almost three times more than the newer. And the price difference? Accordingo to the article, Lunesta and Ambien CR ring in at about $4.00 a pill, generic Ambien at about $2 a pill, and Sonata at $3.50 a pill. The older (now all generic) drugs? 30 to 50 cents. So the older drugs are about equally effective, yet about 1/4 to 1/10th of the price.

As we said last year upon giving the While You Were Sleeping Award:

Ads for insomnia medications are promising trouble-free sleep to an increasingly stressed and sleepless nation. But in doing so, these ads are creating a host of problems: exposing people to dangerous side effects, causing addiction, costing patients and insurers billions of dollars, encouraging them to pop a pill rather than find the root cause of their insomnia, and promoting the dangerous notion that the solution to life’s problems is in a prescription bottle, rather than in changing our behavior, habits and lifestyle.

Last year, the Times ran an excellent article by Jane Brody about alternatives to prescription sleep medications, “Help for Chronic Insomnia Isn’t Always Found in a Pill.”

Stephanie Saul’s article, and the research she reports on, hopefully will begin to encourage people to question the claims in ads for prescription sleep aids, and to explore both the drug-free alternatives and the broader causes behind their lack of sleep.

One of last year’s Bitter Pill Awards honorees, Lunesta, has the dubious distinction of having the most recalled and most remembered drug ads on TV, according to IAG Research.

In 2006, we gave Lunesta and Ambien our “While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep.” At the time Sepracor was topping the charts in Direct-to-Consumer Advertising spending for drug companies, in an aggressive push to gain market share over Ambien and Ambien CR.

The ubiquitous “Luna Moth” ads have become the archetype of current drug ads, lulling the critical faculties of viewers into a slumber, and making even the deepest sleeper wonder if they should Ask Their Doctor about Lunesta.

Lunesta’s sales growth has been hampered by Ambien going generic (reports of sleep-eating, sleep-walking, and sleep-driving notwithstanding) and by competition from the latest entry into the prescription sleep drug market, Rozerem. So what does the forward-thinking company do in the face of lagging sales? Why, raise the price, of course! Yes, Ed Silverman at Pharmalot reports that Sepracor has raised the price of Lunesta 9%, on top of an earlier 9% price hike in November.

Further, Sepracor continues to violate PhRMA’s “Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines,” specifically Principle 10, which states that:

DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

Sepracor continues to run so-called “reminder ads” for Lunesta, those brief spots which say the name of the drug but nothing else about it. Such ads are designed to increase name recognition, much in the same way that lawn signs and bumper stickers do for electoral candidates. Since they don’t say anything about what the drug is used for, under FDA regulations, they aren’t required to list the major side effects and other information we see in full drug ads.

What has PhRMA done about such violations, which they have been repeatedly informed of? N o one knows, since their report on the first year of the Guiding Principles and “comments” they received from consumers named no names and was widely considered to be a whitewash.

(Speaking of Ambien’s now-famous side effects: As is the case so often on matters of importance, perhaps the most thoughtful commentary on sleep drugs and their risks is, of course, from the Simpsons:)