Sleeping Pills: New Prescribing Guidelines

Let’s say you go to the doctor hoping to get a prescription for sleeping pills to relieve your insomnia. You’ve been through cognitive behavioral therapy and it has helped. But there are nights when you’re wound up so tightly that nothing—push-ups, meditation, a hot bath—will calm you down enough so you can get a decent night’s sleep. What then?

The American Academy of Sleep Medicine recently released a clinical practice guideline for the medical treatment of chronic insomnia in adults. Here’s what the academy now recommends.

New guideline for sleeping pills may change doctors' prescribing habitsLet’s say you go to the doctor hoping to get a prescription for sleeping pills to relieve your insomnia. You’ve been through cognitive behavioral therapy and it has helped. But there are nights when you’re wound up so tightly that nothing—push-ups, meditation, a hot bath—will calm you down enough so you can get a decent night’s sleep. What then?

The American Academy of Sleep Medicine recently released a clinical practice guideline for the medical treatment of chronic insomnia in adults. Here’s what the academy now recommends.

Why the Need for a Clinical Practice Guideline?

Most experts in sleep medicine are well acquainted with the literature on sleeping pills and know how to diagnose and treat insomnia. When medication for insomnia is warranted, they know the best drug to prescribe based on your symptoms and medical history.

But most people with sleep complaints take them first to primary care providers. And when it comes to prescribing sleeping pills, not all doctors are on the same page. In fact, a new study from Harvard Medical School shows that, rather than prescribing based on individual patients’ symptoms and history, many doctors find one or two sleep medications they’re comfortable with and prescribe the same drug or drugs again and again.

The new clinical practice guideline contains recommendations that are evidence based. It has the potential to change physicians’ prescribing habits and thus to affect people with insomnia who use sleeping pills, now and in the future.

The Guidelines Are Based on Weak Evidence

The four sleep experts who created the guideline first conducted a literature review. They concluded that no sleeping pill or sleep aid on the market today has been tested in multiple clinical trials and found to be extremely effective and carry very few risks. So the evidence base for their recommendations is, they note, “weak.”

This doesn’t mean that a given medication would not be appropriate and effective for a particular individual with insomnia. It just means as a general treatment for everyone with chronic insomnia, no sleeping pill is backed up strongly by the evidence.

These Sleeping Pills Got a Thumbs-Up

Perhaps predictably, the medications judged to be appropriate—based on the quality of evidence, the balance of benefits and harms, and patient values and preferences—are medications approved by the FDA for the treatment of insomnia. The guideline does not suggest that one drug is better than another since so few studies comparing the efficacy of two or more sleeping pills have been conducted. So the medications listed here are in no particular order:

MEDICATION

SLEEP ONSET INSOMNIA

SLEEP MAINTENANCE INSOMNIA

suvorexant (Belsomra)  X
eszopiclone (Lunesta) X  X
zaleplon (Sonata) X
zolpidem (Ambien) X
triazolam (Halcion) X
temazepam (Restoril) X X
ramelteon (Rozerem) X
doxepin (Silenor) X

These Sleep Aids Were Not Recommended

The following medications and supplements are sometimes prescribed and used for chronic insomnia. Depending on an individual’s symptoms and history, they may help. But the published data on these substances is insufficient in quantity and/or quality to warrant a recommendation for general use as a treatment for chronic insomnia.

  • trazodone (a sedating antidepressant)
  • tiagabine (an anticonvulsant approved for the treatment of epilepsy and used off-label to treat anxiety and panic disorders)
  • diphenhydramine (the antihistamine found in most over-the-counter sleep aids, including ZzzQuil, Sominex, and Tylenol PM)
  • tryptophan (a supplement containing an amino acid found in milk and other sources of dietary protein)
  • melatonin (a supplement which is bio-identical to a hormone produced in the body, useful for jet lag and delayed sleep phase disorder)
  • valerian (a plant-based supplement)

If you’ve used any of these medications or supplements, how effective were they, and did you experience any side effects?

Deep Sleep for Insomniacs: Closer Than We Thought?

Could more deep sleep be the solution to insomnia? Investigators have toyed with the idea for years. People with insomnia tend not to get as much deep, or slow-wave, sleep as normal sleepers. Finding a way to prolong slow-wave sleep might make our sleep feel sounder and more restorative.

Last week’s discovery of a sleep node in the brainstem associated with the initiation of slow-wave sleep is promising news in this regard.

Sleep node in the brain could one day help insomnia sufferers sleep like babiesCould more deep sleep be the solution to insomnia? Investigators have toyed with the idea for years. People with insomnia tend not to get as much deep, or slow-wave, sleep as normal sleepers. Finding a way to prolong slow-wave sleep might make our sleep feel sounder and more restorative.

Last week’s discovery of a sleep node in the brainstem associated with the initiation of slow-wave sleep is promising news in this regard. Not only does it point to a new target for treatment. The procedure scientists at Harvard Medical School and University at Buffalo School of Medicine and Biomedical Sciences used to obtain their results suggests that the possibility of altering sleep via genetic modification may not be as remote as it sounds.

A Look at the Research

These researchers set out to study an area deep in the brainstem of humans and other mammals. It’s located in the medullary parafacial zone, or PZ. The PZ contains neurons that produce GABA, the main neurotransmitter responsible for calming the brain at night. These neurons are always active during normal slow-wave sleep.

They wanted to find out whether simply activating these neurons would induce slow-wave sleep in mice, and they used a novel protocol to find out. Rather than stimulating the GABA neurons with electrodes, a process that disturbs surrounding neurons, they targeted the GABA neurons by altering a gene.

“To get the precision required for these experiments,” said Patrick Fuller, senior author of the paper, “we introduced a virus into the PZ that expressed a ‘designer’ receptor on GABA neurons only but didn’t otherwise alter brain function.” Using innovative tools that enabled them to control the GABA neurons remotely, they turned the neurons on.

The result? The mice fell quickly into a deep sleep—as if they’d been knocked out with a sedative. But no sleep medication was involved.

The ability to induce slow-wave sleep by means of a single genetic modification is an encouraging development. “We are at a truly transformative point in neuroscience,” said Caroline E. Bass, co-author of the paper, “where the use of designer genes gives us unprecedented ability to control the brain.”

Other Treatments That Enhance Deep Sleep

Scientists have worked to develop other therapies that boost slow-wave sleep. But none are available for people with insomnia.

  • Development of sleep medications such as eplivanserin and pimavanserin was abandoned due to concerns about safety and side effects.
  • Transcranial magnetic stimulation (TMS)–a treatment in which an instrument sends a harmless magnetic signal through the scalp and skull into the brain, activating electrical impulses and inducing slow waves–is currently approved for the treatment of depression. Some studies have suggested that TMS is helpful in treating insomnia, and a clinical trial of TMS for insomnia is now under way at the University of Florida. But it hasn’t been approved as a therapy for insomnia yet.

Which brings us back to designer genes that modify sleep. I’ve always thought they were pie in the sky for my generation. But the results of this experiment suggest they may become a reality sooner than I thought.