Sleeping Pills: Too Risky, or a Red-State, Blue-State Affair?

How do people with insomnia feel about sleeping pills?

Attitudes toward sleep medications differ from one American to the next, and between Americans and Australians, it turns out. Here’s a brief comparison that I hope will start a conversation.

Sleeping pills are viewed differently in Australia and the USHow do people with insomnia feel about sleeping pills?

Among 51 insomnia sufferers interviewed by Australian researchers in Sydney, both users and non-users of sleeping pills (or sleeping tablets) held negative views of sleep medications.

When I asked this same question of the 90-odd American insomniacs I interviewed for my book, the response was more divided. Some people viewed prescription sleeping pills as harmful and said they’d never use them. Others felt their sleep medications were helpful and would not want to give them up. Here’s what I wrote:

Poll the sleepless about sleeping pills, and you come up with . . . a red-state, blue-state affair. In one camp are the pill abstainers . . . and in the other, insomniacs who’d sooner dump their iPhones than part with their pills.

Pro or con, attitudes about sleeping pills are often strongly held. Following is a brief comparison of Australian and American attitudes that I hope will start a conversation.

Safety vs. Effectiveness

Both the Australians and the Americans felt that pharmaceutical sleep aids were stronger and more effective at putting people to sleep than over-the-counter (OTC) sleep aids or “natural” sleep aids such as valerian or melatonin.

But most Australians said they didn’t like taking sleep medication. They expressed a definite preference for natural products based on the notion that natural products were gentler on the body and had fewer harmful effects. In the majority view, safety concerns outweighed concerns about sleeping tablets’ effectiveness.

“I’ll take something that isn’t as effective so it doesn’t have any negative consequences,” said a man quoted in the Australian study.

A woman, comparing how she felt about taking the sleeping pill temazepam (Restoril) with how she felt about about the prospect of taking melatonin, said this: “I felt it’s a more natural remedy than the temazepam. So I think I was less stressed about taking it.”

But the Australians were divided as to whether prescription or OTC medication was the safer option. Some thought OTC sleep aids (medications containing diphenhydramine, such as Benadryl and Tylenol PM in the United States) were safer because they were available without a prescription and therefore less potent and apt to have fewer side effects. Others felt the safer alternative was to go with a prescription medication recommended by a doctor who was familiar with one’s individual medical needs and could supervise the process.

Among Americans, a Split

About half of the insomniacs I interviewed felt they needed medication to get a good night’s sleep and were mainly concerned about medications’ effectiveness. Jane M. wrote the following comment on one of my earlier blogs. It epitomizes the feelings of insomniacs who were satisfied with the sleeping pills they were using, having decided the benefits outweighed concern about risks.

“I was first prescribed Ambien many years ago, and don’t think I could have continued my work life this long without it. I sleep soundly eight hours every night, wake up with lots of energy, and have always wanted to meet the discoverer of the formula to thank him or her.

“My gratitude is deeply felt. My mother, who died in 1983, sat up half the night for years. I think there are genetic issues, hormone issues, aging issues . . . I could walk 20 miles a day and I still wouldn’t be able to fall asleep. Some people have asked, ‘What if you become addicted?’ to which my answer has always been ‘So what?’ I am addicted to sleep, good health, and a strong work ethic. Ambien has made it all possible for me into my mid-70s.”

Some Americans Concerned About Risks

The other half of my respondents voiced reservations about sleeping pills, similar to the Australians. Their reasons were mixed. Some did not think of insomnia as a medical problem, preferring to address it through changes in lifestyle or psychotherapy rather than with drugs.

Other insomniacs shied away from using sleeping pills because of negative feelings about medication overall and about prescription hypnotics in particular. Still others felt they simply couldn’t tolerate such potent medication.

“I can’t take any hardcore pharmaceuticals,” an insomniac told me. “A mild antidepressant, that’s something I’d consider. But I’m afraid of sleeping pills.”

Unlike the Australians, few of the American insomniacs I spoke with had anything good to say about so-called natural sleep aids—herbal teas, melatonin, lavender. Based on my interviews, I would venture to suggest that here in the United States, the concept of the natural sleep aid does not have the strongly positive connotation it has in Australia.

But some Americans said they got relief from insomnia using OTC sleep aids like Benadryl and Unisom, which they felt were likely to be gentler and less harmful than prescription pharmaceuticals.

Accounting for Attitudinal Differences

The differences (and similarities) spelled out here may not be representative of Australians and Americans overall. The sample sizes are small, and the years when the interviews were conducted were different (2013–2014 for the Australian study; 2004–2008 for my book). Physician prescribing patterns and the public health information patients receive about insomnia and sleeping pills may be different as well.

But my point is not to make an evidence-based claim about attitudes in Australia and the United States. Rather, I’m interested in knowing how readers of this blog feel about sleeping pills, OTC sleep medications, and “natural” complementary sleep aids, and why.

Please take a minute to comment below, and like and share on social media. Thank you!

Insomnia: Still Don’t Ask, Don’t Tell

I went to my family physician for a routine physical last week. I hadn’t had one in a while, so I decided to get the exam and requisitions for the usual blood work.

This doctor is one whose opinions I respect. But I never hesitate to speak up when information I have leads me to question those opinions. One topic we’ve had discussions about is insomnia and sleeping pills.

Insomnia may be something that doctors avoid bringing upI went to my family physician for a routine physical last week. I hadn’t had one in a while, so I decided to get the exam and requisitions for the usual blood work.

This doctor is one whose opinions I respect. But I never hesitate to speak up when information I have leads me to question those opinions. One topic we’ve had discussions about is insomnia and sleeping pills.

I use Ambien rarely now—sometimes only half a pill—and I’ve still got plenty left from the prescription she wrote last year. So I didn’t plan to mention sleeping pills or insomnia because I didn’t need to.

 

In the Consulting Room

The nurse sat down at the computer to update my medical record, asking about medications and supplements.

Yes, I was still using Ambien. No, I didn’t need a refill.

The nurse then walked out and the doctor walked in.

So what could she do for me today?

I explained the routine nature of my visit and that I wanted the usual blood tests.

She listened to my heart and lungs, placed her fingers under my jaw to feel for lumps, checked my ears and throat. She verified that my weight was stable and that I was getting regular exercise. She typed the lab requisitions into the computer and said I could pick them up on my way out. Then she left.

After the Consultation

Putting on my coat and boots, I happened to glance at the computer, where my medical record was still open. Three words jumped out, the only ones in bold red letters at the top right side of the screen: CHRONIC INSOMNIA. ANXIETY.

The sight was jarring. These words—diagnoses my doctor and I had talked about—felt like accusations. Why, at that moment, did everything I’d learned in my years of studying insomnia—its association with hyperarousal, the stigma attached to it and other disorders involving the brain, the work I’d done to learn to manage my sleep—fly out the window and leave me feeling bad about myself?

I scanned the record for other diagnoses and found one. It appeared in regular black type on the left.

A comment made by a friend of mine suddenly came to mind:

“Usually doctors are hesitant to prescribe sleeping pills for regular use,” she said, “and I’m hesitant to ask. Having worked in a medical office, I think that when you ask for pain pills a lot, or sleeping pills or muscle relaxants or anti-anxiety things, that’s a red flag for being a drug abuser.”

A red flag for being a drug abuser—was that why chronic insomnia and anxiety were at the top of my record in boldface and red? Because several medications used to treat sleep problems and anxiety are controlled substances and I use one? After decades of responsible use of sleeping pills—never using more than a few at a time, never developing tolerance or dependency—am I still seen as a potential drug abuser by my doctor?

The Question Not Asked

Later another thought came to mind. Chronic insomnia is the first thing anyone would see in my medical record, so why had the doctor not asked about my sleep?

I can’t exactly fault her for the omission. She may have assumed, since I didn’t raise the issue myself and didn’t need a sleeping pill prescription, that my sleep must be fine. She may have remembered other conversations we’ve had about my sleep problem—conversations involving some emotion—and decided to leave well enough alone.

All the same, it would have been nice if she’d asked about my sleep. In my imagination, that conversation would go something like this:

Dr: So how’s your sleep these days?

Me: Never better.

Dr: Really?

Me: Yes. With all the study and experimentation I’ve done, I think I’m managing my sleep about as well as a person prone to stress-related sleep disturbance can. There’s not much backsliding these days.

Dr: That’s wonderful. That’s an achievement.

Me: Yes. It is.

Does your doctor routinely ask about your sleep?

Will Ambien Get a Second Life?

Sleeping pills usually tarnish with age. Zolpidem (Ambien), approved for the treatment of insomnia, is no different.

But a new study from Stanford suggests that low doses of zolpidem may help people recover more quickly from stroke. Here’s the gist of that study, published on December 18 in Brain, and what post-marketing studies tell us about zolpidem used for insomnia.

ambien, despite many adverse effects, may get a 2nd lifeSleeping pills usually tarnish with age. Consider zolpidem (Ambien), approved for the treatment of insomnia.

Once touted as superior to other sleeping pills, zolpidem today is known to have factored in thousands of accidents and emergency department visits. In January 2013 the Food and Drug Administration cut the recommended dosage for women in half, and experts are urging physicians to cut back on prescriptions for adults over 65.

But a new study from Stanford suggests that low doses of zolpidem may help people recover more quickly from stroke. Here’s the gist of that study, published on December 18 in Brain, and what post-marketing studies tell us about zolpidem used for insomnia.

Effects of Zolpidem on the Brain

Zolpidem, like most other sleeping pills, acts on the GABA system. It facilitates the transmission of GABA, the main neurotransmitter responsible for calming the brain. GABA-producing neurons are distributed throughout the brain, and when they start firing, they inhibit the firing of adjacent neurons that are active when we’re awake. Zolpidem speeds this process up, shutting the brain down quickly and putting us to sleep.

But this ability of GABA neurons to prevent adjacent neurons from firing also plays a role in brain development. In fact, this phasic inhibition enables the organization and reorganization of the neuronal networks we humans need to process different kinds of information. So researchers in recent years have sought to find out if the GABA “signaling” that occurs during normal brain development also occurs as the brain regains function following a stroke.

What They Knew and How They Conducted the Study

The Stanford investigators already knew that during the first few hours following a stroke, enhancing phasic GABA was neuroprotective: other research had shown that it reduced the death of nerve cells. But no prior research had established whether phasic GABA was similarly beneficial during stroke recovery—during the days, weeks, and months when the cortex is endeavoring to rewire itself and regain functionality.

The experiment, which they conducted on mice, involved several steps. Among them were (a) anesthetizing the mice, (b) inducing the stroke, (c) observing what then occurred in the brain using an advanced neuroimaging technique called array tomography, (d) administering low-dose zolpidem to some of the mice starting on Day 3 after the stroke, (e) observing as, during stroke recovery, the mice underwent tests of their fine and gross motor skills, and (f) comparing the recovery of mice on zolpidem to the recovery of the mice that did not receive the zolpidem.

What They Found Out

  • After the stroke, the regaining of motor skills was accompanied by increased phasic GABA signaling in the mouse cortex.
  • The mice given low-dose zolpidem recovered their motor skills much faster than the control mice.

This preliminary study will need to be repeated before tests are conducted on humans. But if the findings hold up, zolpidem may one day be a first line of defense for people who have strokes.

Zolpidem for Insomnia

Zolpidem’s use as a sleeping pill has become controversial in recent years. The results of one study show that users are more prone to retain negative memories than nonusers. Post-marketing studies also suggest that older adults who use zolpidem are more likely than nonusers to experience falls and hip fractures. And preliminary evidence suggests that zolpidem may be associated with the development of dementia, cancer, glaucoma, pancreatitis, and epilepsy.

So if zolpidem is your hypnotic of choice, take care to use it only as directed and only if you need it.

If you use Ambien, have you experienced any negative effects related to the drug?

Q&A: Should Night Owls Use Sleeping Pills?

Rob wrote to Ask The Savvy Insomniac complaining about insomnia and wondering if Belsomra might help.

Today’s blog post features his story and my response.

Rob wrote to Ask The Savvy Insomniac complaining about insomnia and wondering if Belsomra might help.

trouble functioning in the a.m. could indicate circadian rhythm disorder

I’ve had insomnia since my teens. Never could get to sleep before 2:30. And that’s when I’m lucky. Sometimes it’s 3:30 or 4.

I do everything I’m supposed to do. I work out at the gym every day. I have a few beers when I get home but that’s it. I use a blue light blocking app on my computer and anyway I’m usually off it by 11. But nothing I do changes the situation. I just don’t feel sleepy. No matter how sleep deprived I am, I feel wired.

When the alarm goes off at 7:20 I feel exhausted. Coffee doesn’t help. I fight to stay awake at the office and by the end of the week it’s a losing battle. Early morning meetings are the worst.

What saves me is being able to sleep in on weekends. That and sleeping pills. Ambien will sometimes put me to sleep by 1. So my question is: Do you think Belsomra could work for me?

Barking up the Wrong Tree

I’m no doctor, but I suspect that if Rob were to consult a sleep specialist, his diagnosis would not be insomnia disorder but rather delayed sleep phase disorder (DSPD). The symptoms he reports are classic:

  • a preference for going to sleep several hours later than normal
  • difficulty sleeping at more conventional times
  • feeling alert, not sleepy, at night
  • struggling to wake up and function in the morning
  • catching up on sleep on the weekends

Rob might not have a sleep problem if his work began at noon. But most jobs start earlier, and for people with DSPD, trying to function on a conventional schedule is a major ordeal. It can quickly lead to sleep deprivation and trouble meeting obligations. It limits prospects down the line.

A 25-Hour Circadian Period

We humans can’t choose our sleep time preferences. Whether you’re a night owl, an early bird, or somewhere in between depends on a mix of genetic factors. These preferences can be modified, though, and may also evolve with age-related changes.

Sleep experts have long suspected that people with DSPD have body clocks that run slow, taking longer to complete their daily cycle. While the average circadian period in humans is 24 hours 11 minutes, scientists have hypothesized that the period length in people with DSPD is closer to 25 hours.

The results of two recent studies confirm that circadian rhythms are quite a bit more delayed in people with DSPD than in normal sleepers:

  1. Investigators in Australia assessed study participants’ core body temperature rhythms over 78 hours and found that under conditions of a constant routine, DSPD patients’ temperature rhythms were delayed by about one hour a day. This suggests “that DSPD patients, on average, must advance their circadian rhythm by almost an hour each day to maintain stability of their sleep–wake cycle to the 24-hour world.”
  2. Using a similar, 30-hour study protocol, the same team found that melatonin secretion began almost 3 hours later in DSPD patients than in normal sleepers. While in normal sleepers the melatonin secretion began with a surge, in DSPD patients, it started out gradually.

No wonder people like Rob have trouble getting to sleep!

Therapies: Bright Light and Melatonin

The most effective treatment for night owls wanting to get to sleep sooner is not sleeping pills but rather bright light therapy. The light source can be the sun or a light box that disseminates light at 10,000 lux. Light exposure should occur first thing in the morning. The largest phase advances occur in sessions lasting for 2 hours.

Phase advances are also larger when morning bright light sessions are combined with a melatonin supplement taken late in the afternoon or around dinnertime. Combined with 0.5 mg of melatonin taken late in the afternoon, continuous exposure to bright light for 30 minutes early in the morning was found, in another recent study, to produce 75% of the phase shift that occurred with the 2-hour exposure.

But the bright light–melatonin regimen is not a cure for DSPD. Stop it and your circadian rhythms will revert to their natural cadence. This will also happen if you allow yourself to sleep in late on weekends. You’ll function best if you maintain the same sleep-wake schedule all 7 days of the week.

As for sleeping pills like Ambien and Belsomra, why assume the risks these pills confer when bright light therapy and melatonin supplements, which have few if any side effects, can work even better?

If you’re a night owl, have you tried bright light therapy and/or melatonin supplements? How have they worked?

Will Ambien Go the Way of Halcion?

In the early 1990s, word was spreading that Halcion, a popular short-acting sleeping pill prescribed for insomnia, was a dangerous drug. Not only did it make users anxious, depressed, and suicidal.

It was also implicated in a series of murders. Sales of Halcion plunged. Today the drug is still on the market but is rarely prescribed.

Now zolpidem (Ambien) is receiving intensive post-marketing scrutiny, raising questions about the drug’s safety.

Ambien now is known to cause adverse effects and its use may decreaseIn the early 1990s, word was spreading that Halcion, a popular short-acting sleeping pill prescribed for the treatment of insomnia, was a dangerous drug. Not only did it make users anxious, depressed, and suicidal.

It was also implicated in a series of murders. (The murderers were absolved of their crimes based on the argument that Halcion rendered people incapable of understanding their actions). Sales of Halcion plunged. Today the drug is still on the market but is rarely prescribed.

Now zolpidem (Ambien) is receiving intensive post-marketing scrutiny, raising questions about the drug’s safety. In January 2013 the Food and Drug Administration lowered the recommended dose for women and older adults from 10 mg to 5 mg following reports of zolpidem-related car crashes and an analysis linking the drug to drowsiness in the morning. Studies and reports published in the past 2 years cast more doubt on the drug’s safety. So is zolpidem now set to go the way of Halcion?

A Popular Sleeping Pill

About 5 million Americans now use medications containing zolpidem (generic zolpidem, Ambien, Ambien CR, Intermezzo, Edluar, and Zolpimist), according to the Institute for Safe Medication Practices. Like several other sleeping pills, zolpidem acts on GABA-producing neurons, helping tranquilize the brain.

Benzodiazepine drugs like Halcion bind to several kinds of GABA receptor complexes and consequently produce a range of adverse effects. Zolpidem binds more selectively. Early tests showed that it facilitated sleep and produced fewer adverse effects.

So the FDA in 1992 approved zolpidem for “short-term treatment of insomnia characterized by difficulties with sleep initiation.” FDA approval of the extended-release version came in October 2005—notably without the short-term restriction. Zolpidem in its many formulations dominated the hypnotics market for years despite occasional reports of people sleepwalking, sleep eating, and sleep driving under its influence.

A Troubling CDC Report

People with zolpidem-related problems and injuries were also showing up in hospital emergency departments. The Centers for Disease Control and Prevention recently reported on a survey of psychiatric medications identified as the reason for emergency department visits.

The results were surprising: of all psychiatric medications prescribed, zolpidem ranked first in adverse drug event cases. About 11.5 percent of all emergency department visits among adults were attributable to zolpidem, as were 21 percent of the visits in adults 65 and older. Authors of the report estimated that zolpidem accounted for 10,212 annual visits to hospital emergency departments, 25 percent of which required hospital admission.

Regular Users at Risk

Two new cohort studies suggest that it’s the regular users of zolpidem who are prone to serious accidents:

  1. In a study in Mayo Clinic Proceedings (May 2014), Taiwanese investigators found that long-term zolpidem use significantly increased the risk of major injuries requiring hospitalization. Depending on the dosage, users young and old were 2 to nearly 5 times as susceptible as nonusers to head injuries and fractures.
  2. In a large study in the American Journal of Public Health (August 2015), University of Washington researchers used new prescription and collision records to determine the relationship between the use of sleeping pills and motor vehicle crashes. Regular users of zolpidem were over twice as likely to have crashes as nonusers.

Some Perspective on the Problem

Why is a medication approved as safe and effective by the FDA causing so many problems? The Institute for Safe Medication Practices analyzed a 2012 health care survey to find out if zolpidem was being prescribed and used in a manner consistent with safe use guidelines. Here’s a summary of the report, which appeared in the May 6, 2015, issue of QuarterWatch:

  • Zolpidem was originally approved for short-term use only, yet 68 percent of the users with drug-related injuries or problems were long-term users of zolpidem, on average taking a pill about 2 nights out of 3.
  • Despite the FDA’s recent recommendation that women and older adults be prescribed the lowest approved dose of the drug (5 mg zolpidem or 6.25 mg extended release), in 2012 (before the recommendation came out), few people were taking the lower dose.
  • Drug-drug interactions were common among regular users of zolpidem. Prescribing information warns against taking other drugs that depress the central nervous system while taking zolpidem. Yet about 22 percent of regular zolpidem users were also using opioids on a sustained-use basis. About 23 percent were taking another drug (a benzodiazepine, pregabalin, or gabapentin) that, like zolpidem, acts on the GABA system, producing complex effects.
  • Finally, the prescribing information for zolpidem says the drug may worsen depression and suicidal thoughts in patients with depression. Yet 34 percent of the regular users of zolpidem were also using an antidepressant.

Many regular users of zolpidem may never experience drug-related complications. (This may also have been the case for the majority of Halcion users.) But with so much data now showing that zolpidem is causing harm to significant numbers of users, prescribing patterns will likely change. Don’t be surprised if the next time you ask for a renewal of your zolpidem prescription, you’re prescribed something else instead.

If you use zolpidem for insomnia, how do you feel about the possibility of losing access to this sleeping pill?

Alcohol and Sleep: A Cautionary Tale

These days an old friend of mine is sliding deeper into dependence on alcohol. It’s sad and hard to watch. George stays with us twice a year while visiting his family, who live a few miles away. These family visits are fraught with discord. So by 5 p.m. George is often back at our house for the night—wine or whiskey in hand.

New research explains how alcohol dependence causes insomnia that persists for many years after withdrawal.

Alcohol abuse may harm sleep for many yearsThese days an old friend of mine is sliding deeper into dependence on alcohol. It’s sad and hard to watch.

This friend—I’ll call him George –stays with us twice a year while visiting his family, who live a few miles away. These family visits are fraught with discord. So by 5 p.m. George is often back at our house for the night—wine or whiskey in hand.

George suffers terrible insomnia. But you’d never know it during our happy hour, when he comes alive. He’s always ready with a toast to friends whose home, he says, is an oasis of calm next to the turbulence of his family. Toxic family relationships are George’s main topic of conversation during happy hour: his mother, a woman without much warmth whose love her sons still compete for; a bullying older brother; and a sister-in-law who stokes the rivalry already going between the brothers at every opportunity.

Visits in the Past

In the past George’s negative feelings toward his family would eventually work themselves out—helped by the Finian’s—and then he’d get around to asking my husband and me about our lives. George can be a wonderfully attentive listener. He’s also got wide-ranging interests and concerns.

A few years ago he confessed to worrying about the high doses of Ambien he needed to take to get even 3 or 4 hours of sleep. I can attest to the brevity of George’s nights. His room light has been on when I was up for bathroom calls at 1 or 2 a.m. And no sooner am I down the stairs at 5:30 than he’s in the kitchen asking for strong coffee. It doesn’t matter how wasted he feels, he says. Once he wakes up in the morning, it’s impossible to get back to sleep.

On This Visit, Changes

Our happy hour conversation didn’t get very far on George’s recent visit. Each night he glommed onto the family drama and could not let it go. Nor could he stop drinking. One night he drank a beer and then a bottle of Pinot Noir and, just as he was heading toward the pantry for more, my husband and I fled up the stairs, begging off because of tiredness. Really it was the relentless talk about his family we wanted to escape. At midnight I tiptoed downstairs to adjust the heat and there was George, still drinking and talking on the phone.

In the morning, he came down behind me for his coffee. But when I put the water on, he changed his mind: he was going back upstairs for a little more shut-eye, he said.

That’s odd, I thought to myself. Never in all his other visits had George gone back to bed. Once he was up, he was up for good. My hunch was that he’d taken a sleeping pill quite a bit later than usual and, deciding it wasn’t working, got out of bed only to be hit by sudden sleepiness when the Ambien finally kicked in.

Reflecting on the Situation

George’s situation has taken a turn for the worse–there’s no denying it—and this is upsetting enough. But when I consider what lies in store for him, no scenario I can imagine looks good.

Continuing to drink at the level he’s drinking now is compromising his overall health, and plainly it’s hurting his sleep. But new research shows that even if George does someday go in for alcohol treatment, his sleep may be irreparably harmed.

Science Suggests Why

Adenosine is a neurotransmitter important to sleep, and it’s through adenosine that alcohol exerts its effects on the sleep-wake system, say researchers at the University of Missouri, following a series of lab experiments. In rats never before exposed to alcohol, a single dose resulted in the rats falling asleep more quickly and sleeping more deeply. It did this by increasing available adenosine in the rats’ basal forebrain, an area crucial to sleep. In turn, the adenosine suppressed the activity of wake-promoting neurons there, thus promoting sleep.

But in rats habituated to alcohol, withdrawal from alcohol had the opposite effect. It resulted in the rats experiencing significantly more wakefulness during both their activity and sleep periods–behavior that mimics the severe insomnia experienced by humans during acute alcohol withdrawal.

Excessive wakefulness would normally lead to a robust build-up of adenosine in the basal forebrain. But during alcohol withdrawal this did not happen in the rats. Sustained use of alcohol down-regulates the adenosine system and blunts the sleep system, the researchers concluded, making it harder to fall and stay asleep.

Long-Lasting Effects

It’s not just during acute withdrawal that alcoholics experience poor sleep. Clinical studies have shown that sustained withdrawal from alcohol in humans causes insomnia and sleep fragmentation for years to come.

My blog topics are usually more uplifting. But the only word for the story on alcoholism and sleep is bleak. However you choose to manage your insomnia—whether it’s CBT, meditation, sleep aids, alternative treatments or some combination of these–steer clear of alcohol, a harmful soporific close at hand.

Merck's New Sleeping Pill to Come Out Soon

Roll over, Ambien! After much debate, the FDA has finally approved Merck’s new drug for insomnia. Expect to see Belsomra (a.k.a. suvorexant) on the market early next year.

So what can we hope for from this new sleeping pill and how does it differ from hypnotics available now?

Belsomra, a new sleeping pill approved for insomnia, will enter the market early next yearRoll over, Ambien! After much debate, the FDA has finally approved Merck’s new drug for insomnia. Expect to see Belsomra (a.k.a. suvorexant) on the market early next year.

So what can we hope for from this new sleeping pill and how does it differ from hypnotics available now?

 

A Different Path to Sleep

Older sleeping pills—from barbiturates and benzodiazepines to Ambien and Lunesta—induce sleep via the GABA system. GABA is the main neurotransmitter responsible for calming the brain and putting us to sleep. GABA-producing neurons are found throughout the brain, and when they start firing, other brain activity grinds to a halt. Most sleeping pills speed this process up, thus helping put us to sleep and keep us asleep.

Belsomra does not achieve its soporific effect through the GABA system. Instead, it works on the orexin system—on a much smaller group of neurons in the hypothalamus. These orexin-producing neurons are normally quiet during periods of sleep. But in the daytime they fire continuously, keeping us awake and alert. People who lack orexin neurons are narcoleptic, succumbing to irresistible sleep attacks during the day.

Insomnia sufferers may have the opposite problem, researchers have suggested. The orexin neurons in our brains may be overactive, keeping us awake at night. Orexin receptor antagonists such as Belsomra are being developed based on experiments that show that suppressing activity of the orexin neurons induces sleep.

How Effective Will Belsomra Be?

The FDA does not require new drugs to be more effective than older drugs before gaining approval. How Belsomra stacks up against Ambien, America’s most popular sleeping pill, is anybody’s guess.

But new drugs do have to work better than placebo. Here, Belsomra apparently passes muster. Compared with placebo, it has helped insomnia sufferers fall asleep faster and experience fewer middle-of-the-night awakenings. A year-long trial published in the May 2014 Lancet Neurology showed that after one month, insomniacs who took Belsomra got to sleep about 10 minutes faster than insomniacs taking a placebo and slept about 23 minutes longer. No great shakes! But we’re talking averages here.

Is the New Drug Safe?

A year ago there was quite a bit of concern that suvorexant in doses higher than 10 mg left a significant number of test subjects feeling groggy in the morning, impaired their driving, and led to other “narcolepsy-like” symptoms. But, based on documentation subsequently submitted by Merck, the FDA has decided to approve Belsomra for use in doses of 5, 10, 15, and 20 mg. Higher doses of the drug are said to be more effective—but they also tend to come with more side effects.

The US Drug Enforcement Agency will probably make Belsomra a scheduled drug. A Schedule IV classification would place it in the same category as Ambien and most other hypnotics on the market today. So if and when Belsomra comes on the market and you go on to try it, use it with care.

February 3, 2015: There seems to be a lot of interest in this new sleeping pill. Belsomra is now available here in the United States, and people are writing to me with questions about  effectiveness, side effects, and cost.

I have no plans to try it myself, so I can’t comment on it one way or another. But if you try Belsomra, I know others would appreciate hearing what you think about it.

You may also be interested in learning more about the safety and efficacy of Belsomra. You’ll find that information here.

Popular Sleeping Pills and Who’s Using Them

Some people I know are perfectly comfortable taking sleeping pills and would be happy to use them for the rest of their lives. Others say they’re harmful, having a raft of side effects and degrading the quality of sleep we get.

The pros and cons of sleeping pills are too numerous to explore in a blog (I do lay them out in The Savvy Insomniac, my book). But here’s a summary of the numbers of people using sleep meds in the US, which meds we’re using, and who’s using them.

popular sleeping pills and who uses themSome people I know are perfectly comfortable taking sleeping pills and would be happy to use them for the rest of their lives. Others say they’re harmful, having a raft of side effects and degrading the quality of sleep we get.

The pros and cons of sleeping pills are too numerous to explore in a blog (I do lay them out in The Savvy Insomniac, my book). But here’s a summary of the numbers of people using sleep meds in the US, which meds we’re using, and who’s using them. These statistics are based on data from the National Health and Nutrition Examination Survey, conducted from 1999 to 2010. Over 32,000 people in the general population participated in the survey.

Is Use of Prescription Sleeping Pills Really on the Rise?

Yes—or at least it was by the end of the survey. While about 2 percent of adults in the US used them in 1999-2000, the percent of adults using them in 2009-2010 was 3.5.

Many factors probably account for the change. More people are taking complaints of insomnia to their doctors (rather than assuming that nothing can be done), leading to a 7-fold increase in insomnia diagnoses. Many more people now are leaving the consulting room with a prescription in hand.

Which Prescription Medications Are We Using?

Trazodone, a sedating antidepressant never approved but often used for insomnia, was for many years physicians’ drug of choice for patients with sleep complaints. As of 2010 it was in second place, surpassed in popularity about a decade ago by zolpidem (a.k.a. Ambien), now leader of the pack. Of the 906 adults who reported having used a prescription sleep med in the past month,

  • 346 used zolpidem, eszopiclone (Lunesta), or zaleplon (Sonata)
  • 282 used trazodone
  • 154 used benzodiazepines such as temazepam (Restoril) or triazolam (Halcion)
  • 103 used quetiapine (Seroquel), an atypical antipsychotic prescribed off-label for insomnia, and
  • 45 used doxepin, a tricyclic antidepressant approved for insomnia as Silenor.

Of note is that fact that 58 percent of the adults who reported taking a pill to help with sleep did not endorse using a sleeping pill prescribed by the doctor. This suggests the use of over-the-counter sleeps aids like Zzzquil and Tylenol PM is huge.

Who Uses Prescription Sleep Medication?

We’re more likely to use the drugs listed above

  • as we grow older
  • if we’re female
  • if our income is equal to or above $75,000 a year
  • if we’re in poor health
  • if we’ve seen a mental health provider in the past year
  • if we’re also using another sedating medication prescribed for another condition
  • if we’re on Medicare or Medicaid, and
  • if we have arthritis.

What questions do you have about sleeping pills?