The results of a new study provide a stark contrast to the standard prescribing practices for the treatment of chronic insomnia - a condition where people have difficulty falling asleep or staying asleep on at least three nights a week for at least 1 month.
The 9 million or so Americans who rely on sleeping pills to relieve chronic insomnia may find their medication is more effective if they switch to a dosing strategy that uses half the amount of drugs and includes the use of placebos.
This was the advice of researchers from the Perelman School of Medicine at the University of Pennsylvania (Penn) in Philadelphia, whose study is reported in the journal Sleep Medicine.
The study suggests that smaller and fewer doses of sleep drugs, together with placebos, would reduce the amount of medication needed to maintain treatment effects over time.
The authors say that such an approach gives patients the best chance of overcoming inability to fall and stay asleep while also reducing medication cost and side effects.
Senior author Michael Perlis, an associate professor in psychiatry, says:
"The clinical effects of sleeping pills cannot be relied on to last forever, and long-term use increases risk of psychological dependence and side effects including daytime drowsiness, nausea and muscle pain."
Current standard practice was the least effective strategy
For the study, the researchers recruited 74 adults experiencing chronic insomnia and put them on a nightly dosing regimen of 10 mg of zolpidem (brand name Ambien) for 4 weeks.
They then randomly assigned the patients that responded to the treatment to one of three groups that underwent treatment for another 12 weeks.
One group was assigned to nightly dosing of 10 mg or 5 mg, another was assigned to "intermittent dosing" with 10 mg (two to four times a week), and the third group was assigned to "partial reinforcement dosing" with 10 mg nightly (in which half of the pills contained active drug and half were placebos).
The results show that all three regimens were effective in maintaining participants' ability to fall and stay asleep, but the intermittent dosing group slept worse and reported more frequent and severe side effects that the other two.
Prof. Perlis, who is also director of the Penn Behavioral Sleep Medicine Program, says when it comes to the day-to-day quality of the treatment outcomes, the strategy that is used most often - the intermittent dosing regimen - was the least effective.
He notes that the findings do not support the standard practice of "start low and go slow," and instead support the idea of "start high and go low." This is where the patient starts with 10 mg a night, then, when their sleep improves, they switch either to a lower nightly dose of the active drug or continue with 10 mg a night, but where on some nights a week the dose is a placebo (partial reinforcement regimen).
Such an approach, say the researchers, is a move away from the standard practice of increasing dose over time and makes the use of sleep medications potentially safer in the longer term. It also brings the added benefit - in the regimen that uses placebos on some nights a week - of lower cost. Prof. Perlis concludes:
"The full dose may or may not be required to get the initial effect, but certainly maintaining the effect can be done with less medication."
He also points out that the study offers a new insight about the use of placebos on some nights of the week instead of the medication. This appears to extend the effect of the drug, which could be due to patient's expectations, or could be due to some kind of conditioning elicited by the pill.
If more evidence of such a conditioning effect can be gathered, then it could change how medications for maintenance strategies are prescribed and move toward the concept of a starting dose and including placebos.
Meanwhile, Medical News Today recently reported how scientists discovered the gene that controls our body clock.
In the journal Cell, researchers explain how the gene is highly active in the hypothalamus - a part of the brain that generates several important hormones.