The green Luna moth that twinkles through TV ads for the sleeping pill Lunesta (eszopiclone) has been a hard insect to ignore.
Since the April 2005 rollout of the drug, its manufacturer, Sepracor, has spent $227 million, making Lunesta the drug most
frequently advertised to the public last year. That seems to have forced the market leader, Ambien (zolpidem), to buy more
ad time and shore up its spot as the 14th-most-prescribed drug in the U.S.
The ad blitz may be working. Pharmacists filled 43 million prescriptions for sleep drugs in 2005; that’s a 32 percent increase
from 2001.
Does this mean the U.S. is in the throes of a huge sleep crisis? And if so, is a sleeping pill really the best way to cope?
To help you decide, a new report from the
Consumer Reports Best Buy Drugs public information initiative examined how sleeping pills stack up against one another (see
Comparing sleeping pills) and against other techniques for improving sleep. The report is the latest in a series that recommends drugs for such problems
as heartburn, high blood pressure, and pain, based on the scientific analysis of the Drug Effectiveness Review Project. Fifteen
states fund that project and use the findings to decide which drugs to cover in their Medicaid programs.
CR Best Buy Drugs reports can be downloaded free at
www.ConsumerReports.org/health.
According to the latest CR Best Buy Drugs report, on insomnia, Americans may be jumping to pills too soon when safer remedies are available. Most sleeping pills have
side effects ranging from dependency to rebound insomnia, in which symptoms return and may even worsen after the person stops
taking the pills.
Yet the drug ads imply that medication is the best remedy for sleep problems. "Now anyone with trouble falling asleep is being
told they have a medical problem that may require a medical solution," says Steven Woloshin, M.D., part of a research team
at the VA Medical Center in White River Junction, Vt., that has studied the communication of medical information to patients.
NIGHT AFTER NIGHT
What’s more, the Lunesta commercial we reviewed suggests that you can take it “night after night,” without specifying how
long it can safely be used. The drug’s package insert correctly notes that insomnia “usually requires treatment for only a
short time, usually 7 to 10 days, up to two weeks,” and the medicines should not be used for long periods without checking
with your doctor.
A Consumer Reports analysis found that in 2005, increases in sleeping-pill ads have generally correlated with an increased number of prescriptions.
Total prescriptions for Lunesta numbered 98,471 in April 2005; by December that number more than quadrupled, to 477,877. Other
sleep drugs such as Sonata (zaleplon) and Rozerem (ramelteon) that did not advertise heavily have had relatively small sales.
Other factors driving sales may include growing awareness of the health risks of insomnia and intense advertising and marketing
to doctors.
And free drug samples tempt consumers. With Ambien slated to go generic in October, manufacturer Sanofi Aventis’s ads for
its new extended-release version, Ambien CR, include a free seven-day trial. Lunesta also offers consumers a free trial.
THE SAFETY FACTOR
Ambien, Lunesta, Rozerem, and Sonata are called “new” to differentiate them from benzodiazepines, an older group of sedatives
and anti-anxiety drugs that includes Restoril (temazepam). They appear to cause fewer side effects than their predecessors.
Still, most of the newer drugs can cause dependency, rebound insomnia, and possibly some rare, bizarre side effects such as
sleep eating and sleep driving. Last spring, for example, Rep. Patrick Kennedy of Rhode Island said he took Ambien and an
anti-nausea drug before crashing his car near the Capitol in the middle of the night, thinking he was due there for a vote.
We inspected the 2005 records of the Food and Drug Administration’s Adverse Events Reporting System and found Ambien or Lunesta
cited as the primary drug in more than 150 adverse reactions, such as confusion, aggression, hallucination, and injury. More
than 70 of those resulted in hospitalizations, with nine deaths.
Insomnia risks
Of course, insomnia itself also has risks. Sleeping difficulties have been tied to a higher risk of obesity and heart, lung,
and gastrointestinal disorders. Twenty percent of serious car crashes have been associated with driver sleepiness.
If you’re struggling with sleep problems, first consider nondrug therapies, such as improving sleep routines and relaxation
techniques, and addressing any underlying health conditions. Learning new sleep habits through cognitive behavioral therapy
is an excellent option for either intermittent or chronic insomnia (trouble sleeping at least three nights a week for a month,
often associated with other illnesses).
The over-the-counter antihistamines diphenhydramine (Nytol, Sominex) and doxylamine (Unisom) are FDA-approved as sleep medicines.
Side effects include next-day hangover or grogginess, increased urinary retention, and dry mouth, so they should be used only
in a pinch. They are best avoided by older adults, who are more likely to experience side effects.
Two supplements are also marketed to treat insomnia. Some studies suggest that the herb valerian may be a mildly effective
sleep aid. The hormone melatonin may help initiate sleep and restore a normal sleep rhythm if taken regularly at bedtime.
Because supplements are largely unregulated, however, there’s no guarantee that they contain the listed ingredients.
If you have chronic insomnia, you may want to talk to your doctor about a prescription sleeping pill to be used as needed
on a short-term basis. You may also need a sleep drug if travel, stress, or a disturbing life event have left you with difficulty
sleeping for three nights in a row or during one week. In that case you might benefit from taking one of the newer sleep medications
no more than 7 to 10 days. Don’t use with alcohol, which can increase the risk of side effects.