1. Why do doctors recommend CBT-I before medication?
3. I’ve heard that some insomnia medications may be addictive. Is that something I need to worry about with DORAs?
4. How long should I take them?
5. How much do they cost, and how does that compare to other insomnia medications? Are they covered by insurance?
6. These medications are fairly new; what should I know about them?
2. How safe are DORAs, and how do they compare to other insomnia medications?
7. Should I try another insomnia medication first?
FAQs About Dual Orexin Receptor Antagonists, Answered
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8. Are DORAs more effective than other insomnia medications?
This form of psychotherapy tends to be brief and has a high success rate, says Martin. “The vast majority of people experience benefit from CBT-I,” she adds. According to Sleep Foundation.org, as many as 70 to 80 percent of people who undergo CBT-I experience improvement, including sleeping longer, waking up less often during the night, and taking less time to fall asleep. If you haven’t tried CBT-I, Martin suggests working with a sleep therapist or trying a free app, such as Insomnia Coach.
As with most drugs that are approved by the FDA, clinical development of DORAs went on for years before they were given the green light, which means they’ve been studied for a long time even if they seem new to us, explains Khanna. “They go through rigorous studies to prove their safety and efficacy before they come to market,” he says. “I try to reassure people that by the time that they’re hearing about [FDA-approved medications], there is a lot of safety data behind them.” In terms of safety, DORAs fall somewhere between melatonin receptor antagonists, which are the safest, and benzodiazepines, which require the most caution, Khanna notes.
2. How safe are DORAs, and how do they compare with other insomnia medications?
So far, the data show that DORAs are not addictive when taken as prescribed. A ClinicalTrials.gov study on lemborexant looked at its effects over a 12-month period — participants were given the drug for 6 months and a placebo for 6 months — and the results were promising. “The study so far shows that it has really little to no withdrawal or signs of dependency when we do try to take [patients off them],” Khanna says.
Although each case is different, “Our typical goal of therapy is to do it for three months,” Khanna says. “Hopefully, that helps somebody get into a routine, and then we sort of try to pull back.” As mentioned, they’ve been shown to be safe for 6 months. “That’s not saying that you couldn’t be on the drug for longer than that, but the study shows that for 6 months, they continue to be safe and okay,” Emmel says. During the months you’re taking DORAs, it’s also advised to learn CBT-I and implement good sleep hygiene techniques, so you’ll still be able to sleep well after you’re weaned off the medications, Khanna notes.
Because they are newer, DORAs cost more than some of the older sleep aids. They can be prohibitively expensive out of pocket, but insurance may cover them, either as a first-line treatment or after you’ve tried other medications. “It’s going to differ with every insurance plan,” Emmel says. “Some may require documentation or some sort of prior authorization letter from the pharmacy or from the physician, stating that the patient’s already failed other, cheaper options like nonbenzodiazepines.” Out of pocket, the cost for a 30-day supply is about $400, Khanna says.
So far DORAs have been shown to be safe and effective. Still, it’s natural to wonder if there are longer-term effects that aren’t known yet. “The orexin pathway itself has only been discovered in the past few decades,” Emmel says. “You always worry about, okay, does that pathway do other things? What’s this altering?” Since they already have a decade or more of research behind them, though, “You’re pretty confident you’ve seen much of what you need to see long term where these weird, rare side effects could pop up,” says Emmel.
If your insurance company is willing to cover DORAs up front, there’s no reason to try a different insomnia medication first if you’d rather try these. “There is no hierarchy of which drug you have to start with versus another,” Khanna says.
There’s no one insomnia medication that is more effective for everyone, so the answer to this will vary by person. “It really does depend, but this is sort of one of our bigger guns. It has a very strong efficacy rate,” Khanna says. A study of the DORA suvorexant published in the journal Pharmacy & Therapeutics, found that participants experienced less time falling asleep and fewer nighttime awakenings; it also cited the low potential for addiction as a benefit over other classes of sleep medication.
