Ambien has performed well in clinical trials
Sleep is like Earth's oceans - the last two unexplored parts of the world. Almost all animals sleep but, despite centuries of investigation, no one is sure why we do it. All we can say is that bad things happen to us if we do not get enough sleep at the right time.
How do we research sleep?
There are some very sophisticated monitoring devices that record out brain waves, pulse and breathing during the night. With video of how much we move, many different types of sleeping disorders can be diagnosed and treated.
Why is Ambien valued by doctors?
Although specialized sleep centers are able to diagnose and treat many disorders, these services are not available to all and are not always affordable — not all health plans cover this type of investigation. This leaves the “average” person faced with a simple choice. If there is no specialized help, you accept life with poor sleep or you take Ambien.
What do the clinical trials tell us?
One of the key concerns is the question of side effects. Even though quality of life can be seriously affected by loss of sleep, the price of some side effects can be equally bad. In the main FDA trial, there were 1700 participants. Some 2,000 people went through trials in Europe. All were randomly given either Ambien or a placebo. Of those on Ambien, about 4% found the side effects a deterrent. This breaks down to averages of people with the following effects:
- drowsiness during the day 0.75%
- dizziness 0.6%
- headache 0.4%
- nausea 0.4%
These trials include people taking both high and low dosages. You would expect more side effects at high dosages. Even so, these figures are very encouraging with less than 1% of participants finding any one of the side effects sufficiently serious to justify stopping the drug.
Continuing research
In 2010, there are a number of research trials underway. The main studies are focussed on discovering:
whether high stress levels contribute significantly to insomnia and, if so, whether the stress should be treated before giving Ambien;
how often people sleepwalk at different dosages; and
whether there is a difference between the genders in the reaction to Ambien.
In other words, we are way past worrying about whether to take Ambien and into deciding on the order in which to treat problems, and whether the dosages should be changed to reduce the already tiny risk of sleepwalking.
|