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From the Food and Drug Administration
October 6, 1999

New Drug for Sleeplessness

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JAMA. 1999;282(13):1218. doi:10.1001/jama.282.13.1218-JFD90008-2-1

The FDA has approved zaleplon (Sonata, Wyeth-Ayerst Laboratories, Philadelphia), a very-short-acting hypnotic agent that reduces time required to fall asleep, for the treatment of insomnia. Zaleplon is a nonbenzodiazepine hypnotic of the pyrazolopyrimidine class that interacts with the GABA-BZ receptor complex although it is unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties.

Zaleplon has a very short duration of action—its half-life is 1 hour. Clinical trials of the drug involving 3562 patients with chronic and transient insomnia demonstrated a consistent reduction in the amount of time required to fall asleep, without any increase in the total amount of time slept or a significant decrease in the total number of waking times during the night. Because of its short duration of action, patients generally had no residual drowsiness after only 4 hours of sleep. The drug did not demonstrate effectiveness in treating difficulty with shortened total sleep time or increased awakening during the night.

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