(RxWiki News) The drug Ambien has established effectiveness at helping insomniacs, people who spend their nights trying to somehow charm their own body into giving up wakefulness. A new study finds that patients with primary insomnia are unlikely to escalate their dose.
A new study has found that people with primary insomnia (insomnia not attributable to a medical, environmental, or psychiatric cause) do not usually increase their dose of Ambien over time.
"Consider reporting even mild insomnia to your doctor."
Timothy Roehrs, Ph.D., is director of research at the Sleep Disorders Research Center of the Henry Ford Health System and a professor in the Department of Psychiatry and Behavioral Neurosciences at Wayne State University. Roehrs and his team of associates conducted the 12-month study to determine whether or not taking Ambien for an extended period leads to dose escalation.
For this research, thirty-three participants were randomly assigned to take either Ambien (zolpidem) or a placebo every night for the length of the study. During months one, four, and 12, three one-week tests were administered.
For the first two nights of the test, subjects would be given Ambien one night and the placebo the next. Subjects would not know which pill was Ambien or which was the placebo, but the pills were color-coded.
After the second night of testing, subjects could decide which color pill they wanted to take for the remaining five nights. Also, during the testing times, participants would get to choose whether they wanted one pill, two pills or three pills. Each pill of Ambien contained five milligrams of the drug.
During the testing weeks, participants slept in a laboratory setting rather than at their homes in order to control as many environmental factors as possible.
There were two objectives to the study. First, researchers wanted to see if participants chose Ambien more often than the placebo. They wanted to see if the medication was effective enough that participants would be able to distinguish Ambien from the the placebo based upon their sleep experiences on the first and second nights of testing.
Researchers also, primarily, wanted to know if participants would choose higher doses of Ambien over time.
If participants consistently chose Ambien, it would mean that the medication had been strong enough in its effect for participants to tell a difference between the night with it and the night without it.
And If participants chose higher doses in later tests than in earlier ones, it would mean that their bodies were developing a tolerance to the medication and that it was losing its effect.
Ambien was selected 80 percent of the time.
In addition, participants did not choose higher doses in later testing periods than the earlier ones, indicating that they remained sensitive to the effects of the medicine over the course of a year. These are encouraging results for those considering taking this medication as a sleep regimen.
Ambien has been linked to cases of sleepwalking, amnesia and sleep driving, as well as dizziness, headache, and physical/psychological dependence. People with myasthenia gravis, sleep apnea, a history of drug or alcohol abuse or severe liver or lung disease should not take Ambien. Neither should pregnant or breastfeeding women.
This study was published in the Journal Sleep
This was not an industry supported study. Dr. Roehrs has consulted for Evotec and Sanofi-Aventis and has received research support from Takeda. Dr. Roth has served as a consultant for several pharmaceutical companies.