A popular sleeping pill that has reportedly triggered bizarre side-effects in some people, could be placed by Australian drug regulators into the same class as morphine, narcotics and amphetamines.
Stilnox, a prescription drug which is currently a schedule 4 drug in Australia, could become a class 8 drug, which will mean that those who access it will be strictly monitored.
The decision will rest with the National Drugs and Poisons Schedule Committee (NDPSC) which meets in February.
But the drug company which makes Stilnox, Sanofi-Aventis says it will strongly oppose any changes to the drug's classification as it is unwarranted and not in the best interests of patients and prescribers.
If Stilnox does become a class 8 drug it will demand extra paperwork on the part of doctors and pharmacists as comprehensive records will be required of to whom the drug is dispensed.
Reports of bizarre and potentially dangerous behaviour being triggered by some who have taken the drug in Australia, the U.S. and the UK have prompted the call for the re-classification.
Some Stilnox users claim to have no memory of crashing cars, having "sleep sex", fighting and binge-eating while they were apparently asleep.
This latest move comes after the Therapeutic Goods Administration (TGA) limited pack size to a maximum of 14 pills last November.
The TGA says Stilnox packs now also carry extra warnings of possible side-effects including rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour.
The Pharmaceutical Society of Australia approves of the re-scheduling of Stilnox and the Adverse Medicine Events Line, which reported more than 500 calls regarding Stilnox last year, says rescheduling is an effective way of making people take the drug seriously.
Stilnox is a non-benzodiazepine hypnotic drug designed for the short-term treatment of insomnia and is said to produce a quality of sleep that is close to natural sleep without the side effects which usually accompany hypnotics.
The makers say the risk of dependency is low when the recommended doses and treatment times are followed and since it entered the market in 1988 the drug has been investigated in 160 studies involving 80,000 patients.
Sanofi-Aventis says Stilnox has been better studied than any other hypnotic in the world.