Are Some Sleeping Pills a Sham?
New research suggests half of the benefit of taking widely used sleeping pills comes from the placebo effect.
In the study, published in the British Medical Journal, researchers re-analyzed results from more than a dozen clinical trials of the most common type of sleeping tablets.
These drugs are known as Z-drugs or non-benzodiazepine hypnotics and include Sonata, Ambien, Imovane and Lunesta. The drugs are frequently used in the U.K. and U.S as a short-term treatment for insomnia.
However, some health experts have questioned whether the benefits of Z-drugs justify their side effects, which can include memory loss, fatigue and impaired balance.
Questions have also been raised about the validity of published research into the effects of these drugs based on trials sponsored by pharmaceutical companies themselves.
Researchers from the University of Lincoln, Harvard Medical School and University of Connecticut conducted combined the results of the published research incorporating a technique known as a meta-analysis.
This type of comparison enables researchers to determine how much of the drug effect comes from the constituents of the drug itself, and how much is due to other factors (like the placebo response or regression to the mean).
Investigators used data submitted by pharmaceutical companies to the U.S. Food and Drug Administration (FDA) for approval of new products. This included 13 clinical trials containing 65 different comparisons and more than 4,300 participants.
Experts advise that the FDA collates results from both published and unpublished studies, enabling researchers to avoid common types of bias (such as reporting bias) which can undermine other research based on sponsored trials.
Researchers say their findings indicate that once the placebo effect is discounted, the drug effect is of “questionable clinical importance.”
Lead author Niroshan Siriwardena, M.D., said: “Our analysis showed that Z-drugs did reduce the length of time it took for subjects to fall asleep, both subjectively and as measured in a sleep lab, but around half of the effect of the drug was a placebo response.
“There was not enough evidence from the trials to show other benefits that might be important to people with sleep problems, such as sleep quality or daytime functioning.
“We know from other studies that around a fifth of people experience side effects from sleeping tablets and one in 100 older people will have a fall, fracture or road traffic accident after using them.
“Psychological treatments for insomnia can work as effectively as sleeping tablets in the short-term and better in the long-term, so we should pay more attention to increasing access to these treatments for patients who might benefit.”
Researchers say future studies of sleeping tablets should investigate a broader range of outcomes, not just time taken to fall asleep, and that pharmaceutical companies should be more transparent in disclosing results from their studies so that researchers can independently analyze their results.
Source: University of Lincoln
Nauert PhD, R. (2012). Are Some Sleeping Pills a Sham?. Psych Central. Retrieved on April 21, 2015, from http://psychcentral.com/news/2012/12/19/are-some-sleeping-pills-a-sham/49382.html