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I thought it was a joke the first time I saw this mentioned in an ad and in the ad it states that taking Ambien CR don't drive or operate machinery.

Eating, sleepwalking or driving while not fully awake with memory loss for the event... Well its not.

No one wants to scare people away from their product with scary warnings. So their warning doesn’t always capture the reality of the situation. Like what Ambien CR has.

It turns out that people taking Ambien and Ambien CR are binge eating, sleepwalking and driving without being conscious of what they are doing. Besides Tiger Woods, how big a deal is that for other users? I could go into detail about how drugs are tested; side effects are reported, etc., etc. But that would put you to sleep faster than Ambien and so I will skip that and say the process is complex. It is a lot safer than it is suppose to be, but there is always room for improvement. It's been said that if aspirin were invented today it wouldn't get into the market because of all the adverse reactions associated with it. There's a lot of truth to that scenario.

It is not unusual to spend $10 million dollars on a large Stage III clinical trial that tests a drug's safety in human consumers. These normally involve thousands of people (actually 3,660 people in the case of Ambien). The point is to consider for "frequent", "infrequent" and "rare" adverse reactions. Rare adverse reactions occurs < 1/1000 subjects and frequent adverse reactions occur > 1/100 subjects.

Sometimes rare side effects don't show up in clinical trials, even when you have a few thousand subjects. It is possible to have a statistical probability of showing up 1/1000 times without showing up in a sample of 3,000 and the probability of getting heads when I flip a coin is 1/2. But I could flip the coin 3 times greater and get tails every time and that wouldn't strike anyone as bizarre.