Experimental Insomnia Drug Shows Promise

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No discussion of costs.  If the drug has been submitted to the FDA for marketing approval, as the story states, you know that the company has price estimates. It’s the job of journalism to give more cost context.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The following paragraph is a confusing, convoluted presentation of numbers:

“At the outset, when patients spent eight hours in bed, they were typically asleep for 66 percent of that time. One day on suvorexant boosted that by anywhere from 5 percent to 13 percent, relative to the placebo. Between 21 and 37 fewer minutes were spent awake during those sleep periods.”

First, percentages of time asleep were used, then minutes of wakefulness.  So the descriptors are switched, leaving readers like us losing sleep.

Suggestions:

• Don’t make readers do the math. Instead of saying people were typically asleep for 66% of 8 hours in bed, tell them that means a little more than 5 hours.  Most of us don’t think in terms of, “Gee, I only slept 66% of the time in bed last night.”  We think, “Darn, I only slept 5 hours.”
• Then why throw in the percentage of improvement when you provided the absolute minutes of reduced wakefulness?  To do so is to increase the chances of confusion.  Numbers can be numbing in overkill overdoses.

We were also troubled by a couple of comments:

“There are sleep aids on the market, but they do not work for everyone and they can have side effects that include sleepwalking, daytime drowsiness and confusion.”  There is an implied suggestion that Suvorexant will not have these side effects but no data is provided

“Suvorexant works differently from those drugs, zeroing in on specific brain chemicals involved in the ability to sleep, explained study author Dr. William Herring, executive director of clinical research at Merck.”  Yes, indeed Suvorexant does work differently than the currently available drugs but suggesting that “zeroing in” on sleep is a bit of an overstatement.  The orexin 1 and 2 receptors have been shown in previous studies to effect energy, fluid homestasis, emotion regulation and stress responsiveness to name a few non-sleep effects (Vitamins & Hormones. 89:19-33, 2012)

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story reported:

“there were no serious side effects in this study.

The most common side effects were sleepiness (reported by about 10 percent of patients on the two higher doses of suvorexant), headache (reported by about 5 percent), dizziness and abnormal dreams (5 percent).”

Does the story seem to grasp the quality of the evidence?

Satisfactory

The use of independent experts saved the story on this criterion because those sources added observations such as:

• “The amount of additional sleep was not tremendous”
• “The effect was essentially comparable to what has been seen with other sleep medications”
• “There are still many questions, including whether the drug would benefit people with insomnia due to a health condition, which doctors call secondary insomnia.The study also excluded adults aged 65 or older — an age group commonly affected by insomnia”

Does the story commit disease-mongering?

Satisfactory

No disease mongering of insomnia.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Two independent sources added needed balance up against the comments of Merck’s director of clinical research.

Does the story compare the new approach with existing alternatives?

Satisfactory

Strong ending that addressed this criterion:

Another sleep specialist said the findings show “some potential benefit” from suvorexant, but he cautioned insomnia sufferers against relying completely on any drug.

“Medication can be important,” said Dr. William Kohler, who directs the Florida Sleep Institute in Spring Hill. “But in the long run, the best methods for treating insomnia are behavioral techniques.”

Kohler said cognitive behavioral therapy — where people learn to change the thoughts and habits that affect their sleep quality — is a proven way to manage insomnia. For most people, he said, medication should be a temporary treatment; behavior change is the long-term fix.

Bazil agreed: “I look at most people with insomnia as someone who developed bad sleep habits.”

A drug, ideally used for a short time, may help encourage sleep and get people on the right track, Bazil said. “But those bad sleep habits — you’ve got to address them too,” he added.

“The problem,” Kohler noted, “is that we don’t want to make behavior changes. We want to pop a pill.”

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story explained that the drug is “being developed” and has been submitted to the FDA for approval.

Does the story establish the true novelty of the approach?

Satisfactory

One of the independent experts addressed the drug’s relative novelty in this section:

“suvorexant is seen as a potentially important development in the world of sleep medicine, because the drug blocks specific brain chemicals called orexins, which help keep people awake. Standard sleep medications work more widely throughout the brain, Bazil explained, which is why they can have a host of side effects.

“The way [suvorexant] works makes a lot of sense,” Bazil said. “The hope is that it will help some people who haven’t responded to [other drugs], and have fewer side effects.”

Does the story appear to rely solely or largely on a news release?

Satisfactory

It’s clear that the story did not rely on a news release.