A recent safety review by the Therapeutic Goods Administration (TGA) reaffirmed the benefits of zolpidem for the short-term treatment of insomnia in-line with the findings if the European Medicines Agency within the context of a risk of “hangover” effects.

Since its launch in 2000, Stilnox® has been joined by several generic brands, and a black box warning introduced as follows:

 

Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision.

 

The TGA has received 1,360 adverse event reports relating to zolpidem as of May 2014; a number of which describe next-day impairment at therapeutic doses.

Patients should take the lowest effective dose, not exceeding 10mg (12.5mg modified release) in one day, while more sensitive patients, such as the elderly or debilitated, should not exceed 5mg (6.5mg modified release) tablets. No further doses should be taken on the same night, and activities requiring mental alertness should not be undertaken within eight hours.

Please review full product information before prescribing.

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