Stilnox

There were instances in my clinical practice where I prescribed this drug to some of my patients. I first encountered this medication when I was rotating at the psychiatric ward during my clerkship. We give this to patients who have difficulty in getting sleep. It is a readily available drug in local pharmacies and as long as a physician has an S2 license, it can be easily prescribed.

I encountered this news article regarding it and I find it worth knowing, not just for doctors but for users as well.

The sleeping drug Stilnox (Zolpidem), will be sold in packs of no greater than 14 tablets - down from 21, from now on.

The updated warning comes as a result of numerous reports of strange and potentially dangerous side-effects which include changes in behaviour and mental state, sleep walking, and undertaking strange and potentially dangerous behaviours while apparently asleep.

Studies say that Stilnox packs will include significantly changed Consumer Medicine Information (CMI) information about the side effects of Zolpidem which now include the less common adverse effects of rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour.

Sleep walking, driving motor vehicles and other unusual and on some occasions dangerous behaviours while apparently asleep have been reported along with preparing and eating food, making phone calls and having sexual intercourse. People experiencing these effects apparently have had no memory of the events and significantly such side effects can occur at therapeutic doses, without any intake of alcohol. It is also reported that alcohol intake heightens the risk of such side effects, both for first-time and regular users, at prescribed doses and without the consumption of alcohol.

US Food and Drug Administration (FDA) requested that all manufacturers of sedative-hypnotic drug products, such as Stilnox update their product labeling to include stronger language concerning potential risks. These risks listed by the FDA include severe allergic reactions and complex sleep-related behaviours, including sleep-driving.

Also included were warnings about anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken and complex sleep-related behaviours which may include making phone calls, and preparing and eating food (while asleep).

Experts say patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns.

The FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviours occur in association with individual drug products.