Is Quviviq the New Wonder Drug for Insomnia?

There has been a lot of excitement in the press, and from my patients, about a new medication for insomnia called Quviviq which has been approved for use in the UK. That NICE has recommended its use in certain circumstances for longer than other sleeping medications, has set it apart from all other sleeping pills. So what is it and does it live up to the hype?

Quviviq is the brand name for Daridorexant which is an orexin receptor antagonist. That’s quite a mouthful and it certainly challenged my spellchecker, so let’s look at it more closely using plain English!

First of all, what is orexin? Orexin is a neurotransmitter produced by just a very few nerve cells (neurons) in the brain. It stimulates receptors on other nerve cells and it causes a whole bunch of other chemicals to be released in the brain, most of which are alerting chemicals; in other words they wake you up and keep you awake. So if we can block the action of orexin it will reduce the quantity of wake – promoting chemicals in the brain and this can help one to fall, and stay, asleep. That’s precisely what orexin receptor antagonists do and there are now three of these medications in use: Suvorexant, Lemborexant and Daridorexant. Suvorexant and Lemborexant are not available in the UK and so Daridorexant is the first medication of this type that we can prescribe.

And that is what is so intriguing about this medication. The existing sleeping pills act on a range of other receptors in the brain and many of them are pretty similar to each other. But this medication is the first one we have in the UK that acts on the orexin receptors so it potentially offers us an alternative treatment for people who haven’t gotten on well with existing medications or responded to psychological treatments. And it has some unique properties that will make it the first line medication for some patients (though not the first line treatment – more on this in a bit).

The most important question to ask about a new medication is whether it is safe. Well, nothing is 100% safe and there is the potential for bad reactions or side effects with every medication. But for any medication to be approved it has to go through very rigorous safety trials and so the fact that it has been approved is a good sign. What is particularly reassuring about Quviviq is that there has been a very well conducted study looking at its safety and efficacy over a year which is significantly longer than in most other sleeping medications. This study indicated that side effects were typically mild to moderate (the most common was nasopharyngitis) and that significant adverse events were rare. It also did not have any substantial withdrawal effects and didn’t cause a rebound insomnia when the medication was stopped. However, we don’t yet have long term, real world data – the kind of data that we collect by using a medication over many years or decades – as this medication is so new. But we can perhaps look at the data collected since 2014 when the first orexin antagonist, Suvorexant, was released and recent reviews have found it to be pretty safe.

The second issue to address is: does it work? Again, the fact that we have a year’s worth of data rather than just a few weeks or months helps us to answer this question with a bit more confidence. The studies showed that it improves nighttime sleep and can also improve daytime symptoms of insomnia, particularly with the higher dose. The effect of the medication did not diminish over the year and, if anything, it seemed to get better with time. One of the most encouraging aspects of the studies is that the medication seems to work equally well across different countries, ethnicities and age groups.

I am also impressed by how the medication improved daytime function. After all, a medicine that makes you sleep at night but does not make you feel better in the day is only doing half its job! This all sounds pretty positive but it’s important to stress that it won’t work for everyone and we don’t yet have a way of determining in advance who is more likely to do well with this medication.

So who can be prescribed Quviviq? NICE, whose guidelines inform NHS practice, say that it can be used in adults with chronic insomnia i.e. people who have difficulty sleeping for at least three nights a week for at least three months and whose daytime function is “considerably affected”. However, cognitive behaviour therapy (CBT) for insomnia is still the first line treatment for insomnia and so Quvivic should only be prescribed if CBT has failed, is not available or is unsuitable for that patient.

I think that is a very sensible approach. There are some indications that Quviviq might lead to longer term improvements in some patients even after they have stopped it. But we don’t yet have enough evidence to say whether this is the case or not. Until we do, we should view Quviviq in the same way as all other sleeping medications: as a treatment that can effectively control the insomnia but not cure it. On the other hand, CBT for insomnia is not a just treatment but a cure. When CBT for insomnia works it works in the long term, with effects that last well beyond the end of the course of treatment.

In conclusion, Quviviq is not a magic bullet. But it gives us a new, and very different, option for treating insomnia and this can only be a good thing. Every person with insomnia is unique and the more treatment options we have the more likely it is that we will be able to find the best treatment for each patient.

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