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.

WebMD reported last week on a new study in the journal Sleep. The study found that doctors are widely prescribing sleeping pills and other drugs to children having sleep problems. An astonishing 81% of the 18.6 million doctor visits studied included a prescription being written. By contrast:

They found that diet and nutritional counseling were advised for 7% of children and that 22% were prescribed behavioral therapy such as psychotherapy and stress management to relieve the sleep problems. For 19% of children, both behavioral therapy and medication were advised.

The data studied only go til 2004. Advertising for sleep drugs has exploded since 2004. Both Lunesta and Rozerem were introduced after that time, and have been extremely heavily advertised. Ambien CR was also widely advertised in that time period, both to compete against these new drugs, and to get patients to switch from Ambien to Ambien CR before generic versions of Ambien came on the market. (In 2006, we gave one of our coveted Bitter Pill Awards to the makers of both Lunesta and Ambien/Ambien CR – the “The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep”) It is likely that the enormous promotion of prescription sleep aids in the past 2 and 1/2 years has increased the number of kids being prescribed drugs for sleep even more.

Several things about these findings are disturbing:

• It suggests that doctors are rushing to medications, and not adequately addressing underlying causes, or emphasizing behavioral changes and “sleep hygiene.”
• Many of the drugs being prescribed have not been tested on children, and are not FDA-approved for use in children — this is so-called “off-label” usage. While off-label prescribing is quite common (one study found that 1 in 7 prescriptions was for an off-label use), it is potentially more troubling when it is done for children. Children are not “little adults” — it cannot be assumed that a drug will work the same, or that side effects and risks will be similar for children as they are for adults. The effects of drugs on children’s growth and development is unclear if the drug has not been studied in children and is not approved for use in children.
• It exposes children to the risk of addiction or dependency. Many drugs used for sleep problems have these risks, even those that are not specifically approved for insomnia.
• It introduces children at an early age to the dangerous idea that there is a pill for all their problems, and that taking prescription drugs is “no big deal,” and just a routine part of everyday life. This cultural attitude has contributed to the extremely troublesome and widespread trend of teenagers and young adults misusing and abusing prescription drugs.

For some children, the use of a prescription drug may be the appropriate route for addressing a sleep problem. Insomnia and other sleep problems can and do interfere with children’s growth, learning and behavior, and need to be addressed. But it is a sad commentary that millions of children are being prescribed prescription drugs, when for many of them, changes in diet, routine and schedule would work just as well and not expose them to the risks, known and unknown, that come with these prescription drugs.

The Sleep study can be found here.

Postscript:
In a bit of irony, the article on WebMd was bordered on two sides by an ad for Rozerem. See screen shot below:

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:)