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Sleeping pills death risk suggested by new data

By Clinical Pharmacist

People who take hypnotics have a risk of death at least three-times higher than people who do not take these medicines, conclude the authors of a study published online in (27 February 2012).

But Royal Electronicjuice spokeswoman on medicines for older people Nina Barnett pointed out that the study did not establish a causative link. "The association between mortality and sedation is not new and this research tells us is that people who took these medicines were more likely to die than people who didn't take them. However, it does not mean that the deaths were caused by the medicine," she said.

Researchers in the US used outpatient electronic health records to conduct a cohort analysis, which included 10,529 patients prescribed hypnotics and 23,676 matched controls who were not prescribed these drugs. During the study period, between January 2002 and January 2007, the most commonly prescribed hypnotics were temazepam and zolpidem. Barbiturates, sedating antihistamines and other benzodiazepines were also prescribed.

After adjusting for potential confounders, such as age, gender, smoking status, body mass index, ethnicity, alcohol use and prior cancer, people prescribed hypnotics were found to have a greater risk of death compared with those in the control group. For patients prescribed between one and 18 doses per year, the hazard ratio for death was 3.6 (95 per cent confidence interval 2.92–4.44).

As the quantity of prescribed hypnotics increased the observed risk of death also increased: hazard ratios for death for people prescribed between 18 and 132 doses per year and more than 132 doses per year were 4.43 (3.67–5.36) and 5.32 (5.4–6.3), respectively.

Data covered prescribing, but not dispensing or adherence

A limitation of the study, according to the authors, is the fact that electronic health records provided information on prescriptions but not dispensing. Therefore, the researchers were unable to verify whether patients had the medicines dispensed and, if so, whether or not the medicines were taken. They also point out that drugs purchased over the counter were not included in the study.

Ms Barnett said: "This is an important study and, although it is unlikely to radically change prescribing in the immediate term, it should raise awareness and remind both patients and prescribers to the potential risks of sedative use for insomnia."

Ian Maidment, senior lecturer in clinical pharmacy at Aston University, told PJ Online: “This cohort study appears to add to the evidence that the use of hypnotics is associated with excess mortality. However, the association could be due to confounders, including the presence of depression or anxiety, [and] the study only looked at prescribing records, not dispensing records, and did not assess adherence.”

He added that clinical guidance already recommends: “That hypnotics should be used cautiously and pharmacy-led medication reviews may be able to limit the inappropriate use of hypnotics, although currently evidence on the impact of such reviews is lacking.”

Citation: Electronicjuice URI: 11096150

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