FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep
Nov. 23, 2011. The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
This
is the first time the FDA has approved a drug for this condition.
Intermezzo should only be used when a person has at least four hours of
bedtime remaining. It should not be taken if alcohol has been consumed
or with any other sleep aid.
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 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 was first approved in the United States 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 women clear zolpidem from the body at a lower rate than men.
“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,” said Robert Temple, M.D., deputy center director for clinical science
in the FDA’s Center for Drug Evaluation and Research. “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 had a shorter time to fall back
asleep after waking compared to people taking an inactive pill
(placebo). The most commonly reported adverse reactions in the clinical
trials 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 sleep
walking—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.
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