Video 6 – Insomnia_ Putting It All Together
Welcome to another MedCram lecture. In our previous lectures, we talked about insomnia, we talked about what to do in terms of the approach to somebody with insomnia: to look for diseases that we could rule out easily like obstructive sleep apnea; then to do a hygiene questionnaire and a stimulus control questionnaire, or make sure that they were following the recommendations. Then if they still had insomnia after they came back, to establish behavioral therapy and some sort of medication, which we talked about.
But how do we use these together? Do we use one or the other? Do we use both? How long do we use them for? Well, that’s a very good question. Actually, there was a paper that was published in JAMA back in 2009 entitled “cognitive behavioral therapy, singly and combined with medication for persistent insomnia.” So they set out answers to these very questions using a very cleverly designed randomized controlled trial.
Let’s go over the design of that and see if we can get the answer to really what is the best approach. The first thing they did was they took these patients that were eligible and randomized them into two general groups, which were two treatment groups. One of them was to get CBTI ( or cognitive-behavioral therapy for insomnia) for six weeks. The other would get exactly the same thing: CBTI plus zolpidem, which is a nonbenzodiazepine, also for six weeks.
The next thing they did was they would then randomize these two groups into two further groups. After the six weeks of CBTI, one of the groups here would get CBTI for six more months, and the other group would get no further treatment. Now they did the same thing for the other group. They divided this into two further groups. The first group here was divided to get randomization to extended CBTI alone for six months but without the zolpidem; whereas this one was randomized to extended CBTI plus Zolpidem as needed for six months. So this was CBTI + PRN Zolpidem X six months (PRN means as needed).
他们要做的下一件事是，然后将这两个组随机分为另外两个组。经过六周的CBTI治疗后，这里的一组将再接受六个月的CBTI治疗，另一组将不再接受治疗。现在他们为另一小组做同样的事情。他们将其分为两组。第一组分为两组，分别随机接受延长的CBTI治疗六个月，但无唑吡坦。而根据需要将这1个随机分组延长CBTI加Zolpidem，持续6个月。因此，这是六个月的CBTI + PRN唑吡坦（PRN视需要而定）。
So again to review what we have: patients were divided into two groups: cognitive behavioral therapy for six weeks, or cognitive behavioral therapy plus zopidem for six weeks. Then they were further divided, those that only have the CBTI for six weeks were divided for CBTI for another six months, or no further treatment.
To answer the question if the CBTI going on for a long period of time help. The question was is if we give CBTI and Zolpidem together for six weeks, which does better after that? Just CBTI for an additional six months or continuing the Zolpidem for another six months. Now, let me show you the results because the results were actually very interesting.
So let’s look at responders. Basically, what is a responder? A responder is someone who lost their insomnia based on the treatment. So if we look after six weeks of somebody with CBTI, the response rate was about 40%; 40% of the patients responded to the therapy and they got better with just CBTI for six weeks. Now, what was the response rate for CBTI+Zolpidem for six weeks? It was about 45%.
因此，让我们看一下响应者。基本上，什么是响应者？反应者是指因治疗而失眠的人。因此，如果我们照顾一个患有CBTI的人六个星期，其缓解率约为40％。 40％的患者对该疗法有反应，仅使用CBTI治疗6周后病情就好了。现在，六周内CBTI +唑吡坦的缓解率是多少？大约是45％。
So clearly here. The CBTI is the thing that is doing the heavy lifting, with the Zolpidem only having an additional small amount. Now if we look at here at CBTI for six months versus no further treatment, we’re around 45% and around 45%; these are rough numbers. The interesting thing is that if you looked at six-month follow-up after those initial six months, so a year follow-up total, you’re looking at about the same numbers, about 45 percent roughly and 45 percent.
So this arm clearly shows that you’re not getting many benefits from doing CBTI for six months versus doing just CBTI for six weeks, indicating that CBTI probably has a learning curve that’s pretty quick. However, let’s take a look at this arm over here. So here we have CBTI+Zolpidem, and then we stopped the Zolpidem and just do CBTI for six months, or we continue CBTI with PRN Zolpidem.
因此，这个实验组组清楚地表明，六个月做CBTI比六个星期做CBTI并没有太多好处，这表明CBTI的学习曲线可能很快。但是，让我们来看看这里的这个实验组。因此，这里有CBTI + Zolpidem，然后我们停止了Zolpidem，只做了6个月的CBTI，或者我们继续使用PRN Zolpidem进行CBTI。
So what are the numbers over here? Interestingly, it is around 60 percent. And again, this one is about 60%. What does that mean? That means that CBTI continued after stopping to use Zolpidem was actually better. Let’s compare this number to this number. What’s the only difference? They had CBTI for six months. They had CBTI for six months, but they had it after Zolpidem, but these people did not so, so far this seems to be the best number or even this number seems to be the best number.
But here is the crux of the issue. We did a six-month follow-up on both of these. In other words, CBTI and NO Zolpidem after the initial six-week introduction, and CBTI with PRN Zolpidem to continue. So the question that we’re answering here is yes, we know that CBTI+Zolpidem for six weeks is superior to just CBTI alone. So it’s good to do CBTI or behavioral therapy and add a sleep medication and in this case, is Zolpidem. The question is after six weeks, should we stop it like in this case or should we continue it like we often do in our clinic as the patient needs it?
The six-month (2nd six-month) follow-up was actually very interesting. Actually, have that reversed. The CBTI PRN Zolpidem for six months, dropped to 45 percent. But the 60% of the CBTI only actually increased to 70%. So what all of these results tell us? They tell us CBTI with medication is better than just CBTI alone. Now, it’s not an end statement probably CBTI is more effective than Zolpidem. But together it’s more effective when you do it for six weeks.
六个月（第二个六个月）的随访实际上非常有趣。实际上，已经扭转了这种情况。 CBTI PRN唑吡坦为期六个月，下降至45％。但是CBTI的60％实际上只增加到70％。那么所有这些结果告诉我们什么？他们告诉我们使用药物的CBTI比仅使用CBTI更好。现在，这不是最终结论，CBTI比Zolpidem更有效。但是在一起做六个星期，效果会更好。
The next question is after six weeks, do we continue it on a PRN basis or do we just stop it and do CBTI for the next six months? The answer clearly is that stopping the Zolpidem after six weeks is the best method. As a result of that, the recommendation is combination therapy with CBTI + medications for six-to-eight weeks, then taper the medication and continue the CBTI. So that is the final recommendation.
Finally, we can take a look at insomnia and have a general approach here. We talked about how prevalent it is. We talked about some of the reasons why people have insomnia and therefore what our general approaches? Our general approach is to look for diseases initially right off the bat that could cause patients to have insomnia. So things like depression obstructive sleep apnea, restless leg syndrome, these sorts of things. In that absence, then we do sleep hygiene and stimulus control therapy. We see the patient’s back if they still have problems with insomnia, then we engage in behavioral therapy and medication for about 6 weeks.
We’ve gone over what that behavioral therapy is. Once we’ve done that for six weeks. We continue behavioral therapy for another six months. If that still doesn’t work. Then we can consider sending them to a sleep specialist where other things can be investigated like circadian rhythm disorders and things of that nature again, I would recommend that you do not engage in sleep restriction therapy without supervision. This is serious business. So hopefully this was a good review of insomnia, its approach and the treatment measures. Thank you very much for joining us.