The FDA announced that it has approved Intermezzo (zolpidem tartrate sublingual tablets) that can be used to treat middle of the night waking, where the person has difficulty getting back to sleep. The drug is only for use after four hours sleep, and not in cases where other medication or alcohol has been consumed.
Insomnia is relatively common, many people suffer from it from time to time, and it’s characterized by a condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Obviously, in the long run insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.
Zolpidem tartrate, better known as Ambien, was first approved in the United States in 1992. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night, where the standard sleeping pill is 5 to 10mg. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.
Ambien or Zolpiem is a non-benzodiazepine hypnotic of the imidazopyridine class, part of the point of its development being that overdose becomes more difficult than with more traditional sleeping pills, since huge doses would be needed. Manufacturers also claim that its less addictive that valium type drugs, and although there appears to be a growing problem with Ambien addiction, its nothing like the problems someone can have with valium.
Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research :
“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking … With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”
Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug fell back to sleep more easily after waking, compared to people taking an inactive pill (placebo). The most commonly reported side effects were headache, nausea and fatigue.
Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleepwalking, without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.
Intermezzo is a federally controlled substance because it can be abused or lead to dependence.
Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.
Written by Rupert Shepherd