Following completion of a safety review, the TGA ( Therapeutic Goods Administration ) reminds health professionals treating patients with Zolpidem of the risk of next day impairment.
Zolpidem ( Stilnox ) is an imidazopyridine with relative selectivity for the type 1 benzodiazepine receptor subtype. It has been registered in Australia for the short-term treatment of insomnia in adults since 1999.
Currently marketed presentations for Stilnox and Stilnox CR are: Stilnox 5 mg tablets; Stilnox 10 mg tablets; Stilnox CR 6.25 mg modified release tablets; Stilnox CR 12.5 mg modified release tablets.
There are also generic brands of Zolpidem 5 mg and 10 mg marketed in Australia.
The Product Information ( PI ) for Zolpidem includes a precaution regarding the drug's effect on the patient's ability to drive and use machinery. It warns that patients should not drive or operate machinery for eight hours after taking the drug and that drowsiness may continue the following day.
The PI also includes a black box warning that, among other things, advises health professionals to use caution when this drug is used with other central nervous system ( CNS ) depressant drugs.
Black box warning in Zolpidem Product Information: 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 benefit-risk profile for Zolpidem remains positive. However, based on the findings of its safety review, the TGA recommends that patients being treated with Zolpidem-containing products should take the lowest effective dose. Zolpidem should be taken in a single dose just before bedtime and should not be taken again during the same night.
The daily dose of zolpidem for adults must not exceed 10 mg, or 12.5 mg for the modified release tablets, while elderly and debilitated patients, who may be particularly sensitive to the effects of Zolpidem, should not exceed 5 mg, or 6.5 mg for the modified release tablets.
As at 1 May 2014, the TGA had received 1360 adverse event reports relating to Zolpidem-containing products. Some of these adverse events were indicative of next-day impairment or the potential for next-day impairment in patients taking therapeutic doses of Zolpidem.
Information for health professionals
Discuss the risk of next day impairment, as well as other risks, with patients before prescribing Zolpidem.
Ensure that patients understand the importance of not exceeding the recommended daily dose. Advise them to take Zolpidem just before going to bed and not to re-administer during the same night.
Advise patients to avoid driving or any other activity requiring mental alertness, such as operating machinery, for at least eight hours after taking Zolpidem and explain that drowsiness may continue the following day.
Source: TGA - Medicines Safety Update, Volume 5, Number 4, 2014