FDA Approves Potential “Blockbuster” Sleep Drug

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The US FDA on Wednesday approved a new type of drug for insomnia, called Belsroma. Last year, a lengthy investigative report in The New Yorker provided an inside look into the science and marketing of Belsroma (or suvorexant) and its enormously popular competitor Ambien, in part through interviews with the drug company scientists who were trying to persuade the FDA to approve suvorexant. The FDA reportedly considered the addictive suvorexant only to be sufficiently safe at dosage levels which the company found to be ineffective. Nevertheless, the article suggested Belsroma could become an immediate “blockbuster” in sales. “How successfully can a pharmaceutical giant — through advertising and sales visits to doctors’ offices — sell a drug at a dose that has been repeatedly described as ineffective by the scientists who developed it?” asked The New Yorker.

“Instead of promoting general, stupefying brain inactivity, suvorexant aims at standing in the way of a keep-awake signal,” explained The New Yorker. “This difference may or may not come to mean a lot to insomniacs, but Merck’s marketing is likely to encourage the perception that suvorexant ends the dance by turning off the music, whereas a drug like Ambien knocks the dancer senseless.”

FDA approves new type of sleep drug, Belsomra (US FDA Press Release, August 13, 2014)

The Big Sleep (The New Yorker, December 9, 2013)

27 COMMENTS

  1. I know the truth.

    Sleeping in one eight-hour chunk same time every day is a very recent phenomenon and is not “natural”.

    Nightly 8-Hour Sleep Isn’t a Rule. It’s a Myth

    References to “first sleep” or “deep sleep,” and “second sleep” or “morning sleep” abound in historical legal depositions, works of literature, and other pre-Industrial era archival documents. Gradually, during the 19th century, references to segmented sleep disappeared, Ekirch says, “and now people call it insomnia.”

    http://www.psychologytoday.com/blog/wired-success/201403/nightly-8-hour-sleep-isnt-rule-its-myth

    More on that.

    http://www.bbc.com/news/magazine-16964783

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    • CC,

      Don’t assume that what works for you, works for everyone. Sleeping in split shifts causes me to feel horrible. I need to be able to sleep all the way through.

      No, insomnia has nothing to do with how many hours or how you slept. The only question that should be asked is do you feel energized enough to get through the day performing necessary tasks without a million stimulants and rest breaks.

      For each person, that will be different. One of my best nights of sleep in 2011 was 5 hours straight. Other times I have slept 8 hours and felt like I didn’t sleep at all.

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      • It’s not about my sleep or your sleep , it’s about the myth that sleeping “on time” same time and 8 hours daily is somehow scientifically normal, correct , the right way , it’s not “the way we have always done it” .

        It’s a myth that pharma exploits and perpetuates.

        If you have trouble sleeping the same time same length daily they call normal your broken… it’s like scientific profanity this myth.

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      • True. I am a person for whom the typical “8 hour sleep” is absolutely necessary and if I get less than that I feel abysmal and have to get it back later by sleeping more. But there are some people for whom 4-5h is enough (there were some studies lately which suggest that can be genetic). Also there are supposed to be “owls” and “larks” but I believe that many of the “owls” are in fact a result of modern day technology (using artificial lights and staring at bright screens screws up the natural rhythm). There are also some people who like sleeping during the day in short bouts but that completely destroys my day and makes me feel sleepy all the time.

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        • One of the best nights of sleep I ever had nearly three years ago was 5 hours. Too bad I couldn’t get a genie to replicate those conditions.

          Anyway, I get so tired of sleep doctors asking how many hours of sleep I get on patient intake forms as it is the quality that counts, not the number of hours. Why this concept keeps eluding them is beyond me.

          Regarding sleep meds doing anything for the quality of sleep, the only one I am aware of that does this is Xrem, which is commonly prescribed for narcolepsy. Unfortunately, it is very expensive and many insurance companies will not pay for it.

          I haven’t seen any indication this med would do anything for sleep quality but who knows.

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          • Isn’t Xrem actually preventing sleep? It’s presumed to be a GABA receptor antagonist. I’d be suspicious of taking any drug that enhances or represses any neuroreceptor transmission, especially long-term.
            As to sleep quality – there are no ways to control that and some people claim that drug induced sleep tends to nave unnatural patterns of REM/NREM but I have not read into the subject so much. In any case it’s known that people can be really tired even after many hours of sleep if for whatever reason they don’t get enough REM or NREM.

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          • B,

            I have replied to your post above because there isn’t a reply button under your post.

            Xrem does not prevent sleep as far as i know. I would be surprised if it did since it is commonly prescribed as a sleep aid for people with narcolepsy to get a good nights sleep.

            As with any drug, it is an issue of benefits vs. risks. Personally, I don’t think I am going to find any med or not OTC remedy to help with pap therapy tolerance. But others have found relief for their sleep issues uand I am not going to be the one to say they can’t use drugs. That would be as bad as them telling me I need to use drugs.

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          • “Xyrem is a prescription medicine used to treat the following symptoms in people who fall asleep frequently during the day, often at unexpected times (narcolepsy):
            – suddenly weak or paralyzed muscles when they feel strong emotions (cataplexy)
            – excessive daytime sleepiness (EDS) in people who have narcolepsy”
            Does it do that but making people sleep more deeply in the night? I’ve also read it’s a GABA antagonist, is it true? I’d rather expect the sleep-inducing effect from an agonist…

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  3. I remember in my 20’s and 30’s going right to sleep and out for 7 hours till the alarm went off. On weekends I’d sleep 2 or more hours. I know as we age our sleep rhythms change and many of us had hard time going to sleep and staying asleep. We’re being told this in not normal and we must take something to sleep.

    When I first went to the psychiatrist with sleep issues it wasn’t that bad when (hindsight) compared to what I faced with psych drugs reactions and later withdrawals. The psychiatric drugs altered my system causing severe sleeping issues (up for 72 hours from akathisia) but I can handle it knowing I’m psych drug free. My mantra is “Go with it, you’re free from the psych drugs” and it works (mostly).

    Psychiatry Reality 101…what I learned and wished I hadn’t.

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  5. —“We have to very careful not to sound like psychiatry with our one size fits all solutions.”
    Well, I said 90%… Maybe an overestimation given how many people take drugs or therapies nowadays which are known to screw up sleeping patterns. Of course, stress can do the same thing as well but for some forms of stress taking 2 weeks off and sleeping in a mountain hut could also help.—

    B, my point is to say that 90% of all sleep problems can be solved by what you propose is still pretty much a one size fits all solution. You wouldn’t like it if professionals did that so why is it acceptable when we make the same assumptions.?

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  6. Well AA, here’s to you for gently correcting misguided notions on sleep issues. At least this thread didn’t devolve into warm milk, hot bathes and chamomile tea.

    For someone with sleep apnea and silent reflux, having arousals (your brain wakes up, but you don’t) 92 times an hour during REM sleep and in non-REM sleep about 30 times an hour – I completely understand where you are coming from. It was driving me mad. And in my case, CBT almost sealed the deal.

    I tried CBT sleep restriction therapy twice on my own and failed, so I went to the psychologist attached to the sleep clinic. We tried it one more time and he called it before I was going to. I thought I may need to just try harder. Um, no. He saw how it was just more sleep deprivation at that point and stopped it. And , thankfully he sent my PCP a note stating that I don’t have a mental health issue around sleep.

    Not to lead this into a Sleep Apnea thread as there are some really good blogs out there for that, but your sleep clinic sounds a bit odd prioritizing how much you sleep. I forget the name of the questionnaire I am always given, but it asks questions about how tired you are and how likely you are to fall asleep doing things such as driving, watching TV, talking to someone.

    And, for CPAP tolerance, have you tried nasal pillows? There is no way on earth I could tolerant a mask (tried it when I had a cold), but the nasal pillows are doable. Now I just have to work on the d_mn hose. I think I need a hanger for it to keep it out of my way.

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  7. Anon,

    H-ll would freeze over because I ever tried sleep restriction therapy. Kudos to you for lasting as long as you did.

    I have been to alot of sleep doctors and they all have asked the same question regarding hours of sleep. But they have also asked the questions you are talking about but that also doesn’t necessarily indicate accurately if someone has apnea or not.

    Unfortunately, the nasal pillows are worst for me due to my sinus congestion. Anyway, I am glad it sounds like you are being adequately treated. Am I right?

    B, I stand corrected about Xrem. I still think it is used off label for insomnia but what you described is exactly right.

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    • AA,

      Nope, the questionnaire doesn’t rule sleep apnea in or out. It is used to assess the quality of sleep (doesn’t matter how many hours) – which is what I thought you were having a hard time explaining to them.

      There’s a fair percentage of people with insomnia because of stress and another large percentage because of lifestyle and poor sleep hygiene. I don’t belong to either group. I know this because I was open to it being anything, and in that respect I used observation and experimentation to try and figure out what was causing my godawful fatigue.

      I’m far from a hypochondriac but what I was doing is something I didn’t find my doctors doing. This would be what’s called a differential diagnosis. It must be extinct because I haven’t seen it in years. All I get is symptom treatment; with fairly poor results at that.

      As far as my own journey, I don’t wish to go off on a tangent of sleep apnea, GERD and insomnia here. If so inclined you can reach me at [email protected]. I am kind of curious of your experience, but no issues if you’re not interested.

      BTW, Xyrem is mentioned often on the sleep apnea and insomnia boards. Personally, I never paid much attention to it as it is ridiculously expensive. I did find something more “official” about it at the link below and it appears to help narcolepsy through the quality of sleep it provides, but readers can look into it; I won’t as it is not an option for me.

      http://reference.medscape.com/drug/xyrem-sodium-oxybate-343073

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  9. OMG B, this never ends. The reason people get depressed from having epilepsy is because of the negative ramifications from having the condition. It is not clinical depression but of course, big pharma doesn’t care as long as they can make money off of a population.

    So essentially, if you have any medical condition, look for your primary care physician to test you for depression and offer you an SSRI. Welcome to the new practice of medical care.

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  11. It is disturbing that in the article, he talks about barbiturates being addictive, then immediately talks about benzodiazepines as if they are not, making it sound like this is some kind of improvement. I am quite sure that this one will turn out to be addictive and have scary side effects – some are already outlined in the article.

    We live in a world of marketing – the truth is only limited by what you can convince people of. What is actually true seem to be of very little interest, especially when there are potential profits involved.

    —- Steve

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