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Dr. Sharon Orrange is an Assistant Professor of Medicine and has an active private practice in General Internal Medicine. Her blog will focus on adult medicine including women's health issues, depression and anxiety in the primary care setting, bariatric surgery patients, cardiovascular disease prevention, and adult onset Diabetes.

A New Option for Sleepless Nights

By Dr. Orrange October 22, 2008 2:50pm

Move over Ambien, there is a new kid in town for the treatment of insomnia. A medication used for sleep, Eplivanserin, is in clinical trials and appears to be performing well. Eplivanserin has a very cool mechanism and works differently than Ambien, Sonata, and Lunesta.

How does it work? Eplivanserin is the furthest along in development of a new nonsedating drug class known as ASTARs, or Antagonists of Serotonin Two-A Receptors to take over a chunk of the insomnia market now dominated by Ambien (Zolpidem).  As many of you know Ambien, Sonata and Lunesta are considered "atypical benzodiazepines" and act on the gamma receptors. There has always been some concern over these existing insomnia medications that they are potentially addictive because of their similarities to benzodiazepines (ativan, valium, klonopin, xanax, etc) and this newer class of drugs may alleviate those fears.

In investigational studies Eplivanserin improves sleep continuity in patients with chronic insomnia without causing next-day drowsiness or rebound insomnia upon discontinuation.

What's the Evidence? In a trial involving 351 adults with chronic insomnia who took either 4 weeks of 5 mg Eplivanserin or placebo in the evening, results showed reduction in nighttime awakenings with patients reporting a more refreshing quality of sleep. The side effect profile of Eplivanserin was the same as placebo (which is good) except for dry mouth which was reported in 5.3% of patients on 5 mg/day of Eplivanserin. The ASTAR was not associated with any next-morning drowsiness or difficulty in concentration. Nor did rebound insomnia occur in the week after discontinuing 4 weeks of Eplivanserin.

Approval is pending in Europe early 2009, watch for it in the U.S. soon after.

Thoughts?

Dr O.

Categories: News

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Comments

  1. 26

    Patients presenting with acute or chronic pain resulting in insomnia are not accepted to this trial. Has anyone heard anything yet?

    By Waitingforhim January 14, 2009 9:53pm

  2. 25

    Been on Ambien 10 mg x 5 yrs almost now. I can't sleep without it, tried to stop but have such severe withdrawls I could never do it. Maybe this will help?

    By withacherryontop January 7, 2009 2:39pm

  3. 24

    I tried AmbienCr recently. It made me sick and didn't help me sleep. I have tried pretty much everything, from OTC to RX. Nothing seems to help. I am now trying temazepam. It helps me fall asleep, but doesn't help me stay asleep. I wake up after 3 or 4 hours. Of course that is better than nothing. I am so sick of not getting any sleep. This can be very bad for your health, as I am sure you all know. I was taking a combination of: One Sleep MD, two l-trytophan, two Valerian and two Citracal calcium pills. That seemed to work ok, although I still only got about 4 hours. Then I started having leg pain and my system is all screwed up again. I just don't know where to turn. The one med that worked best for me about four years ago was amitryptilline. It helped me fall asleep fast, I slept for about 7-8 hours and got up feeling good. BUT, it started giving me problems with urination, so now I can't take it. If it isn't one thing it's another. Does anyone have any experiences using temazepam?

    By rusty1 December 13, 2008 9:57pm

  4. 23

    I have been taking Ambien CR for 3 years have never had a problem with it from the beginning. Can't some people take medications long term if the have a real condition just like people have to take blood pressure medicine, or arthritis medication. Why are sleeping pills so taboo? If you need it and it works, why not.

    If you did want to switch to another medication, would there be a problem? might be kind of scary since the one you are on is working. Why would there be difficult times if you went off it, if it only stays in you body for 8 hrs?

    Kathy - California

    By klpeach December 9, 2008 12:47am

  5. 22

    I am glad that there are so many options, but I have been taking Ambien for 4 years now, and I guess I am ready to find out the cause for the insomnia instead of finding a new drug to cover it up!

    By channon December 3, 2008 4:13pm

  6. 21

    I would like to try this when it comes out. I currently take 1 trazadone to help me sleep at night...but I wake up feeling tired everyday.

    By Christine1976 November 30, 2008 5:12pm

  7. 20

    Is it effect for any problems?

    By ellaallison November 17, 2008 2:09am

  8. 19

    I'm really going to mention this to my doc when it comes out but I am weary. I'm desperate though so I will try it.

    By SoMindful November 15, 2008 8:00pm

  9. 18

    I can't sleep because of my pain. I take darvaset and it does not work.
    It is the PAIN that keeps me awake.
    Lillian

    By Lillian74 November 12, 2008 8:15am

  10. 17

    I've had sleepless nights for many years and tried pretty near everything. My daughter who has the same problems told me that she was taking a low-dose xanax and a trazodone pill and has slept every night since she started it. Well, guess what? It works for me too...going on three months now.

    By Leejas October 25, 2008 7:02pm

  11. 16

    Really hope this new product is an answer for all of us who get very little sleep,but do not want to resort to these powerful prescription sleep aides. Lets hope it lives up to the info found in clinical trials.
    I saw what sleeping pills did to my Mother and personally it scares me to try what is available due to the side affects and there addictive nature. I may try what asilin commented about, the natural product named Sleep Tonight. Thanks for the tip :)

    By whichwayisup53 October 25, 2008 4:22pm

  12. 15

    I have recently found a wonderful natural product that is helping me to get some sleep. It is called Sleep Tonight made by enzymic therapies. I buy it at a store called the vitminshop. you can get it online at
    http://www.vitality101.com/store/p...

    Prior to using it I was only getting 3-4 hrs of sleep, now I am getting 6-7 hrs of consecutive sleep.

    By asilinc298 October 25, 2008 10:07am

  13. 14

    Thanks for posting. I hope it pans out. It sounds like it is a very selective antagonist. I saw they are running a trial against lormetazepam... which was an interesting choice.

    By J4A October 25, 2008 5:35am

  14. 13

    Ambien is a really scary medication. I would sleep walk, do and say things that are totally out of character for me, and never remember. I also had some hallucinations while on this medication, and I've never had hallucinations ever before. One evening, I was sitting up in bed, talking to a man in the doorway... my husband woke up and asked who I'm talking to.. I said, "that man".... he yelled, "there IS no man"... then I realized he was correct. I'm not sure if this was a hallucination, or a wakeful dream... but ambien is nasty and I'd suggest getting off of it as soon as possible. I still suffer from amnesia, only sleeping about 2 hours a night.
    My question regarding this medication is.. does it mix well with SSRI's? How about other medications?

    By basketnrse October 24, 2008 5:30pm

  15. 12

    TracyW I would check Google re Melatonin. I was told not to take it as some Doctors apparantly do not recommend it for whatever their reasons might be....not sure that it is herbal. My Pharmacist advised me against some herbs as he claimed that they have side effects.

    I take GRAVOL that leaves me a little drowsy in the morning but a cup of coffee will wake you up.

    Interesting topic but I tend to stay away from prescription drugs for sleeping as they can become addictive.

    Would like to hear Dr O's response to natural sleep aids without any side effects...hopefully Dr O can assist all of us.....many thanks

    By Promiles October 24, 2008 9:11am

  16. 11

    TracyW I would check Google re Melatonin. I was told not to take it as some Doctors apparantly do not recommend it for whatever their reasons might be....not sure that it is herbal. My Pharmacist advised me against some herbs as he claimed that they have side effects.

    I take GRAVOL that leaves me a little drowsy in the morning but a cup of coffee will wake you up.

    Interesting topic but I tend to stay away from prescription drugs for sleeping as they can become addictive.

    Would like to hear Dr O's response to natural sleep aids without any side effects...hopefully Dr O can assist all of us.....many thanks

    By Promiles October 24, 2008 9:11am

  17. 10

    No man-made chemicals for me, thanks. And is there one of those warnings, like, "May cause insomnia, sexual dysfunction, loss of limb, teeth fall out, skin rots, etc)? But hey, that's just me.

    By Cybercatxq October 23, 2008 6:21pm

  18. 9

    i have tried Benadryl, ambien, and others perscription and over the counter and it takes for ever to get to sleep. Hope it comes out soon and my insurance will cover it .

    By shewolff October 23, 2008 11:55am

  19. 8

    I really hope this will turn out to be a great improvement. I have tried everything, trazadone, benadryl, ambien, xanax ets. Nothing puts me to sleep. Although they often make me sleepy but only to nod off for 5 or 10 minutes at a time, grrrr. I look forward to a new option.

    By Robbimom October 23, 2008 11:35am

  20. 7

    I take zopiclone but its meant to be short-term and I am on it now for months but I don't know what the alternative is.

    By paul123 October 23, 2008 10:31am

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