Some American consumers, encouraged by increasingly heavy advertising of prescription sleep drugs, may be assuming unnecessary risk because they're ill informed about the pro's and con's of these "sedative/hypnotics" versus other means of coping with sleep problems. So says the latest in a series of drug comparisons that the independent, nonprofit Consumer Reports organization (CR) has produced as part of a public Drug Effectiveness Review Project.
The “CR Best Buy Drugs Report on Insomnia” analyzes how prescription sleeping pills compare with one another and with other methods for improving sleep. It is part of a public information project supported by funding from 15 states that’s designed to help states identify drugs to be covered in their Medicaid programs, explains CR’s September 2006 summary article, "Sleeping pills: Are they worth the risks?" This summary, and all the drug-comparison reports published so far, are available for free download at www.bestbuydrugs.org/
The Bottom Line: A Science-Perception Disconnect
The bottom line, the sleep drug therapy comparison concludes, is that these medications’ package inserts are essentially correct in noting, for example, that insomnia "usually requires treatment for only a short time, usually 7 to 10 days, up to two weeks," and that these medications shouldn’t be used for longer periods without a doctor's express evaluation.
But there is a disconnect between this science-based reality and the amazing increase in consumption of these drugs over the past few years. And the reason lies in an analysis of sleep drug ad spending and content, the CR analysts concluded.
Prescription Volume Follows Ad Spending
Top sleep drugs such as Sepracor's Lunesta® (eszopicione) and Sanofi-Aventis's Ambien® (zolpidem) - accounted for 43 million prescriptions in the U.S. during 2005, the year Lunesta® was rolled out. This volume represented growth of 32 percent over 2001, or about 14 million more prescriptions annually, and positioned the market leader Ambien as the country’s 14th most prescribed drug.
The increase in prescriptions accompanied intensified ad spending and new marketing strategies directed to both prescribing physicians and consumers. Spending for Lunesta® amounted to $227 million as of September 2006, the CR analysts found, accompanied by increases among the new drug’s top competitors. For example, though the Ambien® formula went generic in October 2006, heavy advertising for its extended-release proprietary successor, Ambien CR®, touted free seven-day trial samples of the drug. Result: The top spending drugs have achieved the majority of market growth, while those "that did not advertise heavily have had relatively small sales," CR determined.
Key Findings and Conclusions
So how do the current top drugs measure up? CR’s comparison include Ambien®, Ambien CR®, Lunesta®, Rozerem®, introduced in 2005, and Sonata®, a 1999 introduction. As a group they are termed “newer” drugs to differentiate them from an older class of anti-anxiety and sedative drugs called benzodiazepines, such as Restoril® (temazepam), which appear to involve more side effects.
CR “deconstructed” a TV spot for Lunesta to demonstrate how top drugs’ advertising tends to:
n “Magnify” normal bedtime or sleep patterns such as “replaying the day” as problems for which one might need medication;
n Ignore industry guidelines calling for a mention of other treatment options;
n Imply safety of use for long periods – e.g., “for use night after night” – despite the 7 to 10-day benefit period mentioned above;
n Imply benefits such as “fast action,” though research indicated that this drug shortens the time to sleep “by about 13 minutes.”
n Downplay risks, with qualifications such as “may” while stating benefits with fewer qualifications.
Overall, the comparative analyses of top drugs’ safety, effectiveness, side effects, and cost – detailed in the CR report – indicates that all may help one fall asleep; average time to sleep ranges from 33 to 75 minutes; and all but Rozerem involve a risk of dependency and abuse.
Unlike the others, Rozerem works on the hormone melatonin, but also appears to be “less effective.”
Aside from dependency, potential side effects of the top drugs variously have included “rebound insomnia,” confusion, aggression, hallucination, injury, and death. Alcohol use can increase the risk of these side effects, and for this reason is forbidden. A search of the FDA Adverse Events Reporting System on two of the drugs for 2005 – Ambien and Lunesta - turned up 70 hospitalizations and 9 deaths.
This is not to discount the risks of insomnia, including the statistic that about one-fifth of serious auto accidents involve a sleepy driver, the CR analysts note. But their recommendations for individuals with occasional or lasting sleep problems are to:
Avoid sleep drugs for any but the indicated short-term 7- to 10-day benefit period. Discuss with your doctor if this may be occasional if you have chronic insomnia, or when travel, disturbing events, or stress have made sleep difficult for three to seven days.
Consider using two supplements. One is the hormone melatonin, which research indicates may help “initiate sleep and restore a normal sleep rhythm if taken regularly at bedtime.” The other is valerian, which other studies indicate “may be a mildly effective sleep aid.” Look for a reliable maker to help ensure content is as indicated.
Pursue nondrug solutions such as cognitive behavioral therapy to learn new sleep habits, considered “an excellent option”; relaxation techniques; and attention to health problems, “which are often associated with chronic or intermittent insomnia” – chronic meaning difficulty sleeping at least three nights a week for four weeks.
“In a pinch,” try FDA-approved over-the-counter antihistamine medicines such as Nytol®, Sominex®, and Unisom®. These can be associated with some next-day grogginess (as can all of the top prescription drugs in a percentage of patients), as well as some dehydration, so are “best avoided” by older individuals.
Note: The information provided here has not been reviewed by the FDA. It is not meant to diagnose, treat, cure, or prevent any disease. It is very important that you never make a change in your health support plan without reviewing and evaluating it collaboratively with your professional healthcare team.