‘Serious safety risk’ for often-prescribed medication for sleep

GPs have been warned of the ‘serious safety risk’ linked to off-label use of quetiapine (sold as Seroquel) for sleep issues, after a small-scale study found it ‘significantly impaired’ alertness.
 
The Flinders University study found patients may be using the antipsychotic medication to treat issues such as insomnia and obstructive sleep apnoea (OSA) without realising it could be putting themselves and others at risk.

Researchers found that while quetiapine ‘modestly improved’ sleep quality and reduced the severity of OSA, it significantly impacts alertness and driving performance the following day.
 
Quetiapine is an antipsychotic medication approved for the treatment of schizophrenia and bipolar disorder, but researchers say it is often prescribed at much lower doses as a treatment for insomnia, anxiety and OSA due to its sedative effects.
 
In the study, researchers analysed 15 adults over two nights in a sleep laboratory – one night after taking 50 milligrams of quetiapine and one after taking a placebo.
 
Overnight sleep studies were conducted, and the following morning participants completed a driving simulator task and a vigilance test to measure alertness.
 
Compared with placebo, quetiapine reduced the number of breathing interruptions during sleep and improved sleep efficiency, but also caused slower reaction times, more lapses in attention and poorer steering control during the driving simulation.
 
The study’s lead author, Cricket Fauska, said it is ‘particularly concerning’ that some people who performed worse on the driving tests did not feel sleepy.
 
‘That mismatch between how people feel and how they actually function poses a serious safety risk, especially when it comes to driving,’ he said.
 
An RACGP expert backed the findings, saying he would ‘definitely not’ be using quetiapine off label to treat sleep difficulties due to its side effects and potentially addictive nature.
 
Dr Michael Tam, a member of the RACGP Expert Committee – Quality Care, says quetiapine is ‘not a very tolerable medicine, even for people where there is a clear indication for it’.
 
‘Part of the problem with quetiapine, separate to [this] study, is that the burden of side effects is not insubstantial, particularly with sedation, but also with cardiometabolic side effects,’ he told newsGP.
 
‘Even low doses of quetiapine are known to have some of those cardiometabolic effects, so for the most part we would not recommend using quetiapine for the purposes of treatment of insomnia.
 
‘Even if you need to use pharmacotherapy, there are better choices.’
 
An analysis of diagnostic indications found 27% of antipsychotic prescriptions were off label for indications such as depression, dementia, anxiety and insomnia, at much lower prescribed daily dosages.
 
Dr Tam said quetiapine has been ‘quite commonly’ used off label as a sleeping aid and for anxiety disorders for many years.
 
‘If we look at the total amount of quetiapine that is prescribed, very clearly much of it is not being used in people living with schizophrenia or bipolar disorder,’ he said.
 
‘It is known to have some effects for people with anxiety disorders, so generalised anxiety disorders, but definitely not first line [treatment].’
 
Dr Tam said the finding is ‘not surprising’, given the medication’s sedating effect.
 
However, he stresses that the sedation is a side-effect of the medication, not its primary purpose.
 
‘My usual advice is that quetiapine, for the most part, shouldn’t be used for the purposes of sedation, it’s not a medicine designed for that,’ he said.
 
‘The side effect is that it can cause sedation, and so people are using it for the side effect from the medicine, sometimes to help with sleep.’
 
Dr Tam also cautions that quetiapine may put some people at risk of dependence on the medication, and at risk of longer-term health impacts.
 
‘Sometimes people might turn to some of these other medicines, like the quetiapine, because there is a potential view that they’re not addictive, or they have much lower propensity of causing dependence,’ he said.
 
‘That is true, but these medicines do have quite a few other side effects that are actually much less safe than I think sometimes are assumed, because some of these cardiometabolic type side effects, these cognitive effects, have quite substantial impacts on people’s quality of life in the medium to longer term.’
 
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