Dr. Robert Temple, deputy center director for clinical science in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien.
However, Intermezzo is a lower dose formulation of zolpidem with the recommended and maximum dose of 1.75 milligrams for women and 3.5 mg for men, once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men, Temple said.
"For people whose insomnia causes them to wake in [the] 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," Temple said in a statement.
"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. Patients using the drug took a shorter time to fall back asleep after waking compared with people taking a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue, Temple said.
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