Labeling Updated for Two Insomnia Drugs

The FDA has strengthened the warning for next-day psychomotor impairment
The FDA has strengthened the warning for next-day psychomotor impairment

The Food and Drug Administration (FDA) has updated the labeling for Ambien (zolpidem tartrate tablets; Sanofi Aventis) and Ambien CR (zolpidem tartrate extended-release tablets; Sanofi Aventis) to strengthen the warning regarding next-day psychomotor impairment. Next-day psychomotor impairment, including impaired driving, is more likely to occur if the drug is taken with less than a full night sleep remaining (7–8 hours), if a higher than recommended dose is taken, if the drug is taken with other CNS depressants or alcohol, or of it is taken with drugs that may alter the blood levels of zolpidem.

Specifically, the updated labeling states that vehicle drivers and machine operators should be warned that there may be a possible risk of adverse reactions (ie, drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness, impaired driving) the morning after taking the medication. In order to reduce the likelihood of next-day psychomotor impairment, a full night of sleep (7–8 hours) is recommended. Also, the Dosage and Administration section states that zolpidem should be taken as a single dose and should not be readministered during the same night. 

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Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. 

For more information visit Sanofi.US.

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