New Sleep Drug Intermezzo Approved by the FDA

At the end of 2011, the FDA approved a new drug for sale on the market. This drug called Intermezzo (Zolpidem Tartrate) is the first drug approved for use in treating early wakening, which is a form of insomnia. People who experience early wakening can find it very difficult to fall back asleep even if it’s the middle of the night. The drug Intermezzo was put through intensive clinical research trials to test its effectiveness and safety. The primary ingredient is zolpidem tartrate, and the FDA does advice that intermezzo only be taken if there is at least 4 more hours of sleep time available. During these insomnia clinical trials, the effective dosage rate was determined for men (3.5 mg) and women (1.75 mg). This relative variance in the dosage assigned to men and women is due to a faster metabolic clearance of the drug in women, which was observed in the clinical drug studies.

Zolpidem tartrate has been the active ingredient in other medications that have been used to combat insomnia and even some brain disorders. The sleep drug, Ambien and Ambien CR, used zolpidem as their primary ingredient for effective short term relief of insomnia. Ambien CR actually uses an extended release method of delivering the zolpidem. While Ambien may be the most popular brand name for zolpidem, it definitely isn’t the only one. As mentioned earlier, Intermezzo is hoping to make a real splash in the market as no other approved drug has been targeted to treating early wakening issues.

As with all the previously approved drugs with zolpidem, Intermezzo in clinical trials caused the same possible side effects. As with any sleep medication, serious side effects may occur. So the FDA wants to remind people that even though this is a new drug, the same precautions need to be remembered and taken. People are advised not to drink any alcoholic beverages in connection with Intermezzo. This new sleep drug utilizes a lower dose of zolpidem than previous sleep aides, another factor that needs to be remembered when taking this medication. People now have a safer option to help with insomnia when they awake in the middle of the night. Primarily there is a decreased risk of danger involved in driving a car or operating machinery after waking up. Even with a lower dose of zolpidem in their system, the FDA has mentioned that it would be advisable to only take Intermezzo if you can get 4 hours of sleep at least afterwards.

There were two clinical research trials that were conducted to test Intermezzo in Richmond,CA (check out some of the other California clinical trials). The new drug was tested on over 350 patients who were kept overnight so that sleeping patterns and behavior could be observed. As in most clinical research studies, there was a control group that was administered a placebo and then the Intermezzo group. During the study, participants who would wake during the night would be administered a placebo or Intermezzo. The recorded time that it took for people in the control group was longer than people who had been given Intermezzo. Due to the people’s ability to abuse these type of drugs or become dependent, Intermezzo is a federally controlled substance.