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 Drugs.com 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.