Off-Label Meds for Insomnia

Post-marketing tests now show that Ambien and Lunesta, the most popular sleeping pills today, are not as benign as they once were believed to be. Are we moving into a period similar to that which occurred in the 1980s, when physicians moved away from prescribing sleeping pills for people with insomnia and prescribed off-label medications instead?

dont-knowIn 1999, during a terrible bout of insomnia, I went to see a sleep specialist. A friend had told me that Klonopin (a.k.a. clonazepam) got rid of her insomnia and convinced me that I should try it myself. What was there to lose?

“Klonopin!” the doctor exclaimed at my suggestion. “That’s an antipsychotic.” (Clonazepam is now more often classified as an antianxiety medication.) “Your symptoms don’t warrant that. Take Ambien as needed, and don’t worry about taking a second pill if you wake up in the middle of the night.”

Fast forward to last month, when I went in to my primary care doctor for a routine physical and asked for a refill of Ambien, which I take occasionally.

“I’m not sure about the Ambien,” the doctor said. “It’s a bad drug. There’s a new story about it coming out everyday. How about trying clonazepam instead? I didn’t use to prescribe anything at all to patients with sleep problems. But now I’ve got patients using clonazepam daily and I’m not seeing any harmful effects.”

Déjà Vu

I’m reminded of events that occurred in the early 1980s, when the then-popular sleeping pill Halcion made its dramatic fall from grace. Higher dosages of the drug came to be associated with depression, suicidal thoughts, and violent behavior, and Upjohn, the drug’s maker, was accused of withholding information about these side effects from the FDA. So powerful was this sleeping pill believed to be that a handful of Americans were actually absolved of murder when their lawyers used what came to be known as “the Halcion defense” in court. (“The drug made me do it.”)

One result was that many doctors stopped prescribing sleeping pills for people with insomnia and started prescribing antidepressants like trazodone and amitriptyline instead. These antidepressants had not been tested and found to be effective for insomnia. But they were known to have sedating properties and believed to be safer than sleeping pills (never mind side effects like daytime fogginess, cardiovascular complications and erectile dysfunction in men). Did they work and were they tolerable? Insomniacs I interviewed for my book gave very mixed reviews.

History Repeats Itself

Post-marketing tests now show that Ambien and Lunesta, the most popular sleeping pills today, are not as benign as they once were believed to be. (See my blogs about Ambien for details.)

Now I hear of people taking drugs like clonazepam and Seroquel (quetiapine), an atypical antipsychotic, for help with sleep. These drugs have not been approved for the treatment of insomnia, but testimonials suggest that doctors are prescribing them, and insomniacs writing on give them fairly high marks (9.1 out of 10 and 8.3 out of 10, respectively).

I don’t have a problem with doctors prescribing medications off label if there’s hard evidence that they work. But where is that evidence? In Pubmed I can’t find a single study assessing the safety and efficacy of clonazepam for insomnia. The few tests assessing the efficacy of quetiapine are inconclusive, according to a meta-analysis published in 2012. Another meta-analysis concludes that safety concerns outweigh benefits.

Does it make sense to replace sleeping pills with known benefits and side effects with drugs whose efficacy and safety for insomnia is untested?

This is not a rhetorical question. I’d like to hear your thoughts.

Author: Lois Maharg, The Savvy Insomniac

Lois Maharg has worked with language for many years. She taught ESL, coauthored two textbooks, and then became a reporter, writing about health, education, government, Latino affairs, and food. Her lifelong struggle with insomnia and interest in investigative reporting motivated her to write a book, The Savvy Insomniac: A Personal Journey through Science to Better Sleep. She now freelances as an editor and copy writer at On the Mark Editing.

19 thoughts on “Off-Label Meds for Insomnia”

  1. Because all sleeping medication is subject to addiction/dependence, all effort by the medical community should be to keep people off these substances. Add to this is the fact that many people take Rx and OTC sleeping meds in various combinations. This is all dangerous, leaving many to wake with hypnotic substances still in their system being metabolized. Hypnotics are Bandaids.

    I remember those days with Halcion. I was a sleep tech doing studies. It was scary for those patients! The Ambien story has shown that we really don’t know what these drugs do to us, even after FDA approval. I don’t think we have seen much “hard evidence” that any of these drugs work for chronic insomnia.

    My $0.02.



  2. Thanks for your comments, Michael. I don’t doubt that you have seen instances of people getting hooked on sleep meds and developing scary symptoms as a result. But not everyone who takes sleeping pills has such negative experiences.

    While I would never suggest that sleeping pills should be the first line of defense for people with chronic insomnia, some people’s insomnia does not respond as well to the behavioral modifications that work so well for others.

    Even sleep researchers with a behavioral orientation acknowledge there is likely a biological component to chronic insomnia–constitutional factors that make some people more vulnerable to sleep problems than others (the predisposing factors). They’re beginning to identify biomarkers associated with insomnia and short sleep now.

    In cases where insomnia is severe and does not respond well to behavioral changes, medication can be a lifeline. The question isn’t whether to medicate, but rather which medication to use.


  3. I was co-prescribed zolpidem tartrate (10 mg.) and clonazepam (4mg. at end) after a few sleepless nights; medicated for five years with increasing issues on the drugs. Now unmedicated for 14 months, life-altering neuromuscular and other neurological weakness/spasticity/burning/tingling, headaches, memory loss/cognitive decline, etc. — and nowhere to turn for help!

    Please guard your gifts with care!


  4. Bec,

    I’m sorry to hear about all the negative consequences medications have had on your life. It’s unfortunate, but sometimes the very people we turn to for help with health problems do more harm than good. All the more reason to become as informed as possible about health conditions and medications ourselves. Best of luck in finding solutions for the problems you’re facing now.


  5. I have had sleep issues for years. I already deal with hypothyroidism, depression, and anxiety…all which can impact sleep induction, quality of sleep, and sustaining sleep. I have worked on “sleep hygiene” and am near scrupulous in maintaining good sleep habits. I had bad experiences with Ambien, even though I slept really well on it. I already take Celexa, and am considering taking Seroquel or Klonopin or even Valium to help me sleep. I worry about addiction, and feeling sedated during the day. I don’t know what they answer is but its not amytriptiline or trazedone for me (they don’t work). I want some good information to make an educated decision about what I should take. Otherwise, alcohol comes into play and I don’t think that is a good answer at all!


  6. Hi Laurie,

    It’s hard to find drugs that are appropriate for the long-term, nightly treatment of insomnia. Many doctors are willing to prescribe sleeping pills for short-term or occasional use. But because, taken over time, so many hypnotics on the market actually degrade the quality of our sleep (not to mention putting us at risk for colds, depression, and other health problems), doctors tend to be leery of prescribing them for nightly use.

    I’m not a psychiatrist or pharmacologist myself. My advice to you, if you want to go the medication route, is to find a sleep specialist or psychiatrist who is knowledgeable about medications for sleep. Since you’re already taking medication for other health problems, you need the advice of someone who knows something about potential drug-drug interactions.

    That said, I do have a couple comments on the drugs and conditions you mention. One, some medications used to treat hypothyroidism can, in higher doses, cause insomnia in some users. If you’re currently taking thyroid medication, that would be something to pursue with a doctor or psychiatrist.

    Two, Valium is known to be addictive when taken over time. If you anticipate needing to take sleep medication every night, this would not be a good choice.

    The other two drugs you mention, Seroquel and Klonopin, seem to have come back into favor again with the medical community (although, as I point out in this blog, there’s little research backing them up as effective for insomnia). I can’t vouch for their effectiveness myself. But someone who treats people with insomnia and other related health conditions might be able to based on clinical experience alone.

    Finally, would you consider cognitive-behavioral therapy (CBT) for insomnia instead of medication? CBT, which is not the same as sleep hygiene, is considered to be the first-choice treatment for people with insomnia because it tends to improve sleep quality and continues to be effective even after treatment ends. Here’s a blog you might find interesting:

    Also, I’ve made several posts on sleep restriction therapy, a component of CBT, which may sound difficult but which is a powerful and effective treatment for insomnia. Take a look at this video and the reader comments that follow:

    Whichever way you go, I wish you all the best in getting more and better sleep.


  7. Quetiapine fumarate (Seroquel) works very well for me. I have been taking it every night for about five years with no side effects other than weight gain. I fall asleep fast and stay asleep, but I can wake to urinate and go back to sleep almost instantly. The down side is that an hour after I take it I want to eat everything. I’m not hungry for celery or carrot sticks, in fact, I’m not hungry at all. I am in a chemically induced eating frenzy. Just like Marijuana “munchies” , but 10X worse. CBT doesn’t work for me, because I don’t believe in it. I want a pill. I believe in pills. Better living through chemistry.


    1. Hi John,

      I’m sure you’re not alone in wishing for a pill that would induce sleep without any adverse effects. Unfortunately it’s not on the market yet!

      I’ve changed my mind, though, about the practice of prescribing off-label meds for insomnia. For about a year now, I’ve taken a generic medication prescribed off-label for a chronic stomach issue I have, and I can now eat many more foods than I could before. It’s enhanced the quality of my life enormously.

      We’d all be better off if there were safety and efficacy studies backing every pill prescribed. But the drug companies fund the lion’s share of studies, and they’re unlikely to fund new studies of old drugs because there’s no money in it. That doesn’t mean, though, that these drugs should be off-limits to patients if physicians are convinced that they work.


  8. Clonazepam is in the same class as Valium and highly addictive. Not to be taken every day long term. I’ve been on it 10 years and cannot get off it. Be careful what you suggest.


    1. Hi Mark,

      Thanks for writing in to share your experience with clonazepam. I hope you’re able to find a professional who can help you get off the drug and manage your insomnia in some other way.

      I’m puzzled by your last sentence, though. I have not suggested that clonazepam be used for insomnia here or anywhere else on this blog. I review insomnia drugs (and do so at length in my book, The Savvy Insomniac). But when it comes to recommendations I urge people to consult their doctors (and, preferably, doctors who know something about sleep medicine).


      1. Clonopin (Klonopin) is the brand name for clonazepam. Both it and Valium are benzodiazepines. Recommending one over the other makes no sense. All equally addictive and harmful to healthy sleep architecture. All are anxiolytics. But that does not stop me from using them for sleep, too. Even the newer z-drugs (Zolpidem/Ambien, Zopiclone are no longer thought to be better or safer than benzodiazepines.


  9. I’m 67 and have treatment resistant bipolar illness. Ten years ago(or maybe twelve) I was prescribed clonazepam. I was so glad to finally be able to sleep through the night. And my psychiatrist at the time said that if nothing else could be done for me to manage the bipolar illness, sleeping every night would, in itself, help stabilize my mood. Of course, she didn’t tell me clonazepam is addictive and that it would also cause erectile problems, irritability, agitation and depression. At one point I was taking 2 mg, nightly. I should add that I’d been diagnosed with mild sleep apnea and CPAP didn’t help at all. Kept me awake, which sent me into several severe manic episodes over the time I tried to use the machine.

    I’ve been prescribed every drug used for sleep, including off label meds. Still on clonazepam, taking .5 mg, nightly. The drug is, and has been, next to useless, I have multiple health problems related to long term non-restorative sleep and, today, I’m seeing a new psychiatrist who doesn’t believe in prescribing benzodiazipines. This should be fun.


    1. Hello Mark,

      Your situation sounds complicated and difficult. I wouldn’t know what advice to offer, except to encourage you to continue pursuing this with doctors who are specialists in treating disorders of the brain and sleep. I have written a blog post on use of cognitive behavioral therapy for insomnia in people with bipolar disorder. You may already have read it. If not, here it is:

      Good luck in finding a doctor who offers the kind of help you need.


  10. Meant to write (…Zopiclone/Imovane, Eszopiclone/Lunesta) as further examples of newer “z-drugs” but site won’t allow editing posts.


  11. I first started with insomnia at aged 28 years, I have struggled with life ever since this time. I have researched and sought help constantly. I have tried every drug available, many causing me a lot of problems during the day and not actually working. There cannot be anything that I have not tried at sometime. Two nights ago I discovered that 50mg of Pregabalin WORKS. If only this had been available to me when I was in the right frame of mind (Depression) my life would have been so different. I cannot tell you how happy I am, I can think, work things out, I have lots of patience and my brain is working as it should be. It seems that Pregabalin really hits the spot for me.


  12. Further to my first comment, I should add that I have suffered from insomnia for 44 years. Yes 44 years wasted !!!!!


    1. Hi Christine,

      Thanks for your comments about pregabalin, and apologies for taking so long to respond. It’s good to know this medication works for you and that you’ve finally found something that helps you sleep! Here’s a post I wrote about pregabalin, which may interest you (if you haven’t already seen it):

      I’ve actually changed my mind about off-label prescribing due to a personal experience I’ve had with an off-label medication prescribed for a digestive problem, which has helped me a lot. So I’ve written more favorably about it in recent blog posts. Here is one of them:

      Thank you for writing in!


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