Intermezzo Approved for Insomnia

New Drugs , News / September 27, 2016

Intermezzo (zolpidem tartarate sublingual tablets) has been approved by the FDA for use in the treatment of insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. Intermezzo should only be used when a person has at least 4 hours of bedtime remaining.

Insomnia is a common 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. Insomnia can cause excessive daytime sleepiness and lack of energy. It can also make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

Zolpidem tartrate was first approved in 1992, as the drug Ambien. 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. The recommended dose for women is lower because the elimination rate of the drug in women is lower than that in men.

Like other medicines for treatment of insomnia, 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 sleep walking. Chances of such activity increases if a person has consumed alcohol or taken other medicines that make them sleepy.

Intermezzo is a product of Transcept Pharmaceuticals Inc. of Port Richmond, Calif.

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