A new study that was published in Sleep Medicine is showing that people who suffer from chronic insomnia could benefit from half of the medications they are currently using, and could even be helped by using placebo medications. This new study is coming from researchers out of the Perelman School of Medicine at the University of Pennsylvania. The results of the study not only could benefit insomniacs, but there is a lot of potential that one day the same method could be used on a number of medications for a number of medical conditions.
Around 9 million Americans are relying on prescribed sleeping pills in order to go to sleep, and are diagnosed as chronic insomniacs. The new study is in stark contrast to the standard prescribing practices that are used to treat chronic insomnia patients. The study findings advocate for a dosing strategy of fewer sleeping drugs and a lessened dosage, and also advocates the use of placebos, which would then decrease the amount of medications needed to maintain efficacy over time. The new approach, which was outlined in the study, would allow people to maximize their gains clinically in terms of falling asleep and staying asleep, while also reducing the side effects of the sleeping medications. This new method would also cut prescription drug costs, which is a major factor for people who are chronic insomniacs and rely on quite a few pills and various medications through the month. A chronic insomniac is someone who has difficulty falling asleep or staying asleep at least three nights out of the week, and this occurs for a month or more.
Senior author of the study is Michael Perlis, who is an associate professor in Pennsylvania’s department of Psychiatry and director of the Pennsylvania Behavioral Sleep Medicine Program. Perlis said that the clinical effects of the sleeping pills cannot and will not last forever, and long-term use increases the risk of psychological dependence and also side effects. Some of the side effects include daytime drowsiness, muscle pain, and nausea. This new research can help change the industry standards for maintenance therapy and can help lower the odds of having side effects of the medication. In this study, 74 adults were treated who were experiencing chronic insomnia with 10 milligrams of zolpidem, which is Ambien, for 4 weeks. The participants were randomized into three different dosing groups for 12 weeks, and had a nightly dose with either 10 milligrams or 5 milligrams. There was intermittent dosing of 10 milligrams 3 to 5 days a week, or partial reinforcement through nightly pills which included half 10 milligram pills and half were placebos.
Out of the three strategies the research team tried, they found that all three were effective in helping people fall asleep and stay asleep, but the intermittent dosing group slept worse and then reported more medical symptoms, and the symptoms were more severe than the other two groups. The strategy used most frequently was the intermittent dosing strategy, and it performed the worst out of the three. The findings of the study go against the standard practice of the start low and go slow method, and instead favor a start high and go low type of dosing strategy. This means that the patient would start with 10 milligrams nightly, and then when the results desired are found, switch back to either a lower dose at night or begin to intermittently dose with the placebo on the non-medication nights. The researchers think that the findings of this study show that the best way to keep the sleeping medications safe over time is to go divert from the tendencies to increase dose over time. The added benefit of interspersing with the placebo is that it will be 50 percent less expensive, since you will be using only 50 percent of the real medications each month, and it could cut costs for both the patient and the pharmaceutical company. Perlis said that the full dose might or might not be required at first to get the initial effect, and this study shows how you can maintain the full effect of the medication by actually using less medication.
This study was also the first to confirm that 5 milligrams can be very effective as a maintenance strategy, and it supports the Food and Drug Administration decision from 2013. The 2013 decision was to require a lower recommended dose of Ambien in the non-elderly women, since there is a risk of impairment the next morning, such as with not being alert while driving. This study shows how using placebos on the non-medication nights extends the level of therapeutic benefit which is not seen with the intermittent dosing. The effect is thought to happen due to the conditioning of the medication effects, and an example of this would be the medication effects being elicited with conditioning by the medication capsule, and this then can be sustained over time with occasional use of the full dose of the medication, which is known as partial reinforcement.
The results of this study are really interesting because it brings up how using a placebo can be beneficial when it comes to maintenance therapy, and this could be possibly extended in other types of medications as well. Not only could this cost less money on the patient side and pharmaceutical side, but if this method is used for other medications, then it could also decrease the risk of addiction for some medications out there, such as Benzos. More research will need to be done in order to confirm the results of the study, but then the researchers hope that doctors will begin using this method on the long-term chronic insomniacs, since this can really help keep the efficacy of the medications up. In order to use this method on other medications, studies will need to be done in order to confirm the results in terms of the drug still working when also using the placebo.