(December 2, 2011) The U.S. Food and Drug Administration (FDA) has just approved the first insomnia drug for people who wake in the middle of the night and cannot fall back asleep.
The Wall Street Journal reports that the FDA has approved Intermezo as a lower-dose formulation of zolpidem tartrate. It is in tablet form, taken under the tongue (sublingual), designed for quick release and to be used only once a night. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should never be taken when alcohol is present in the body or with any other sleep aids.
Insomnia is a common condition in which a person has trouble falling or staying asleep. The condition can range from mild to severe. Insomnia can cause daytime sleepiness and lack of energy. It can cause a person to feel anxious, irritable, depressed, or just “out of it.” People who suffer from insomnia have trouble focusing, learning, driving, thinking, and remembering.
Zolpidem tartrate was first approved in the US in 1992 as Ambien. Intermezzo is a lower dose formulation. The recommended (and maximum) dose of Intermezzo is 1.75 mg. for women and 3.5 mg. for men, once per night. The lower dose is recommended for women because women clear zolpidem from their bodies at a lower rate than men.
Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, the patients taking the drug had a shorter time to fall asleep after waking as compared to the people who took a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue. An important adverse reaction which has been reported in other sleeping medications, as well, is the risk that Intermezzo may cause serious side effects including getting out of bed while not fully awake and doing an activity that you are totally unaware you are doing or do not remember doing! Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep-walking – without knowing at the time or remembering later. Chances of such an activity increase if a person has consumed alcohol or taken other medications that make them drowsy.
Intermezzo is a federally controlled substance because it can be abused or may lead to dependence.
We all know how difficult your day can be when you didn’t sleep the night before. It is great that we now have options available to help us fall asleep, and to help us stay asleep. Now we need a drug to help us remember what we did while we were sleeping!! Either that, or maybe a straitjacket to prevent us from getting up and making a mid-sleep meal.