Tag Archives: sleeping pills

Quick Hits: Medication Recommended for Women at High Breast Cancer Risk, FDA Committee Supports Gout Drug & More

Women who are at high risk of developing breast cancer and who face a low risk of suffering adverse events should be given a drug such as tamoxifen, according to a recently released recommendation. The US Preventive Services Task Force (USPSTF) says that women at low breast cancer risk should not be given medications such as raloxifene, exemestane and anastrozole for breast cancer prevention because they can cause adverse events. Blood clots were reported with tamoxifen and raloxifene (but not the other two drugs), while an increased risk of endometrial cancer and cataracts were seen with tamoxifen. Posted January 15, 2019. Via USPSTF.

An FDA advisory panel overwhelmingly voted that the benefits of the gout medication Uloric (febuxostat) outweigh its risks, even though a postmarket study showed that patients on the drug had a higher rate of cardiovascular events compared to those on another medication. However, most of the advisory committee members agreed that Uloric should be a second-line treatment. A postmarket study released last year found a higher rate of cardiovascular death with Uloric compared to Zyloprim (allopurinol). Uloric’s label already contains warnings about cardiovascular events, liver toxicity and serious skin reactions. Last year, the consumer advocacy group Public Citizen sent a petition to the FDA urging that Uloric be pulled from the market. Posted January 11, 2019. Via MedPage Today.

Common prescription sleeping pills are so strong that about half of people taking them are unable to wake up even when a fire alarm is going off. Japanese researchers note that safe hypnotic medications should have the ability for people to wake from sleep in a dangerous situation. However, most sleep medications – including benzodiazepines – don’t allow this. The researchers tested a drug in a new class of sleep medications known as dual orexin receptor antagonists (DORA) on a group of mice. Another group of mice was given the benzodiazepine triazolam and a third group, a placebo. When threatening stimuli were presented to the mice, those in the placebo and DORA group woke up quickly, while waking in the triazolam group was delayed. After the threat had passed, the DORA group was able to fall back to sleep faster than those on a placebo and as fast as those in the triazolam group. A DORA for sleep, Belsomra (suvorexant), was approved by the FDA in 2014. Posted January 8, 2019. Via Frontiers in Behavioral Neuroscience.

Zzz…How to Get a Good Night’s Sleep?

There are any number of situations or conditions that may cause you to lose sleep. Anxiety, stress, depression, or just being worried or anxious can greatly affect the quality of your sleep. Some medications, including corticosteroids, thyroid hormones and certain blood pressure medications may also lead to changes in your regular sleep pattern. Physical or medical conditions such as a headache, allergies and upper respiratory conditions or conditions causing pain can impact your sleep. Whatever the cause, losing sleep can disrupt your life and even create serious health consequences.

All sleeping aids, whether prescribed, over the counter, herbal or all-natural come with the risk of side effects.

Many times, sleep restlessness can be solved by small lifestyle changes. If you think you’ve tried everything but you haven’t done something on the following list, then keep trying: Avoid caffeine or other stimulants; regular exercise like taking a walk; no daytime naps; establishing a regular sleep schedule; no using electronics with a screen (your smartphone or tablet) for an hour before sleep; sleep meditation audio tapes; and a cup of warm milk. But if these — and counting sheep — aren’t working for you, there are a number of products available to help you get a better night’s sleep.

Over-the-Counter Sleep Aids

Most of the over-the-counter (OTC) sleep aids you’ll find at your local drug store are really just antihistamines, such as Benadryl (diphenhydramine), but under a different name. They are used for sleep because, as a side effect, they make you drowsy. because it is an antihistamine it will also cause daytime drowsiness, dry mouth, blurred vision, constipation and urinary retention. Diphenhydramine is found in ZzzQuil and Nyquil, as well as Advil PM, Motrin PM, Aleve PM and Tylenol PM, where they are combined with a pain reliever. It’s often the ingredient found in store brands or generics as well.

Unisom, another OTC sleeping pill, contains doxylamine, also a sedating antihistamine with the same side effects as the previous antihistamine: daytime drowsiness, dry mouth, blurred vision, constipation and urinary retention.

Antihistamine-based sleep aids aren’t recommended for people who have certain medical conditions including closed-angle glaucoma, asthma, chronic obstructive pulmonary disease, sleep apnea or urinary retention.

Natural/Herbal Remedies

Some of my patients want to try an herbal or “natural” product to promote sleep. The most common ones, melatonin and valerian root, are available either alone or in combination with any number of other herbal or homeopathic ingredients including chamomile, hops flower, passion flower, GABA or 5-HTP and others. There are a number these types sleep aid products that are marketed with long testimonials of how effective they are. There are even a few studies that indicate therapeutic benefit, though many other studies have not supported the same benefits.

Melatonin is a naturally occurring hormone that helps control your circadian rhythm or daily sleep/wake cycle. It’s important to understand that melatonin is a sleep and “body clock” regulator. Supplements seem to help those with daily work shift schedule changes or helping to establish a day and night cycle in those who are blind. It is mildly beneficial in treatment of long term insomnia or sleep disorders. Melatonin is not without potential side effects including headache, depression, daytime sleepiness, dizziness, stomach cramps, and irritability. There is also the possibility of drug interactions with other sedative drugs, birth control medications, caffeine and it might even decrease the effectiveness of diabetes medications.

All sleeping aids, whether prescribed, over the counter, herbal or all-natural come with the risk of side effects.

Valerian root is an herbal product that may reduce the time it takes for you to fall asleep and may improve your sleep quality. Although valerian is generally considered to be safe for short-term use it can cause side effects including headache, upset stomach, decreased alertness, excitability, heart disturbances, and even insomnia. It may also interact with alcohol, prescription tranquilizer medications known as benzodiazepines and other sedatives. It may also interact with other medications that are metabolized in the liver.

Prescription Drugs

If you’ve already tried lifestyle changes and a few of the non-prescription products available without success, then it’s advisable to discuss the problem with your doctor. Based on your diagnosis, you might be prescribed a prescription medication to promote better sleep. But you should know that many drugs that are prescribed for sleep aren’t even FDA approved for that purpose.

Sedative-hypnotic drugs such as Ambien (zolpidem), Lunesta (eszopiclone) and Sonata (zaleplon) are FDA approved for sleep disorders, but for short-term use only. If you use them nightly, you run a much greater chance for side effects, possible drug interactions and dependence on them. If you take one of these medications on a nightly basis, your body becomes conditioned to using the medication, making it difficult to fall asleep without it.

Benzodiazepines have been used to treat sleep disorders and anxiety for years. But only five of them are FDA approved for sleep: Halcion (triazolam), ProSom (estazolam), Restoril (temazepam), Dalmane (flurazepam), and Doral (quazepam). They’re considered significantly more risky since they cause drowsiness that can carry over to the next day which may impair driving or job performance. They also have a higher potential for drug dependence since you can develop tolerance to their effect and need to keep increasing the dose.

Your doctor may suggest taking an older antidepressant to help you sleep. Now, you might say you’re not depressed and don’t need an antidepressant. But these medications can be used to help you get to sleep in doses much lower than used to treat depression. Desyrel (trazodone), Elavil (amitriptyline) and Sinequan (doxepin) are the most common ones used to induce sleep.

Using an antidepressant for sleep has safety advantages over other medications since they are non-addictive, don’t produce a physical dependence or tolerance and have a lower incidence of side effects when used in these lower doses. However, it is important to keep in mind that antidepressants have a boxed warning — the strictest warning the FDA can require for a drug that highlights potentially serious or even life-threatening adverse events — that they are associated with an increase in suicidal thinking in young people.

It’s a good idea to not take sleep medication every night. It’s reasonable to use an “as needed” dose for a few nights to get some good rest, and then try a night or two without the medication.

Quick Hits: FDA Threatens E-Cig Manufacturers, Elderly Polypharmacy and Falls & More

Saying youth smoking of e-cigarettes is reaching “epidemic proportions,” the FDA has ordered the manufacturers of the 5 top e-cigarettes to come up with plans on how to curb use by teens. The agency also threatened to pull flavored e-cigarettes – which are especially appealing to young people – from the market if they can’t demonstrate how they can keep the devices away from children. The manufacturers receiving letters are Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic. Data from Nielsen Research indicates that Juul has more than two-thirds of the e-cigarette market. About 2.1 million middle and high school students used e-cigarettes last year, according to the CDC. Over the summer, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cig products to minors as part of an undercover operation, the largest coordinated enforcement effort in the agency’s history. Posted September 12, 2018. Via FDA.

Elderly people that take several medications for sleeping, pain or incontinence are twice as likely to fall and suffer broken bones compared to those not taking any drugs. Researchers analyzed data on more than 70,000 older adults living in New Zealand. Those who were taking more than 3 Drug Burden Index medications – drugs that sedate or affect one’s cognition – were twice as likely to break their hip than those on no drugs, researchers reported in the Journals of Gerontology. Between 20% and 30% of those who broke their hip died within a year. Lead author Hamish Jamieson, PhD, of the University of Otago, Christchurch, New Zealand, said that multiple medications can cause falls in the elderly because of side effects in each of the medications and drug-drug interactions than can create additional side effects. Posted September 11, 2018. Via University of Otago.

The FDA has issued warning letters to 2 companies for making unsubstantiated medical claims in selling products containing the herb kratom. The agency says that Chillin Mix Kratom and Mitra Distributing make claims that their kratom products can relieve opioid withdrawal and treat conditions including depression, anxiety and high blood pressure. The FDA noted that kratom may contain substances that contain opioids and the plant may have a high potential for abuse. Over the last year, the FDA has issued several public warnings about potential dangers associated with kratom. In February, the agency said it identified 44 deaths associated with the use of kratom. Posted September 11, 2018. Via FDA.

How to Kick Insomnia Without Turning to Pills

Although sleep is one of the most basic human needs, many people treat it as optional. We’ve all had the occasional sleepless night. But when tossing and turning in the night or having trouble falling asleep becomes chronic, you’re likely suffering from insomnia.

Lost sleep can have serious consequences. Studies have found that sleeping less than 7 hours per night is linked to a higher risk of high blood pressure, diabetes, stroke, heart disease and death. Not sleeping enough also increases the risk of accidents on the road, in the workplace and elsewhere.

Many insomnia sufferers seek relief with sleeping pills, among the most commonly prescribed medications in the US. However, these rarely help the situation, adding less than 35 minutes of sleep per night – and they often create new issues, according to the American Academy of Sleep Medicine.

Sleeping pills can be addictive and may lead to even worse sleep once you stop taking them — there’s a rebound effect. They can also cause drowsiness during the day and other problems like dizziness, hallucinations, sleepwalking and sleep-eating.

Behavioral Therapy Beats Sleeping Pills

Fortunately, there are lots of other ways to improve sleep without the side effects seen with medications such as Ambien (zolpidem). For example, studies have found a type of counseling called cognitive behavioral therapy (CBT) to be the best treatment approach for insomnia.

CBT is the “gold standard treatment for insomnia, in which patients meet with a sleep behavioral psychologist to complete an individualized plan involving behavioral changes to improve sleep,” explains Rachel Marie E. Salas, MD, MEHP, FAAN, an associate professor of neurology and nursing at Johns Hopkins Medicine. CBT helps people improve sleep-related behaviors and addresses negative ways of thinking that can make matters worse — like “If I don’t fall asleep soon, there’s no way I’ll make it through the day tomorrow.”

In 2016, the American College of Physicians issued a guideline that CBT was better than sleeping pills for treating insomnia. The professional group noted that CBT was more likely to lead to longer-lasting effects compared to sleeping pills, which are only meant to be taken for 4 to 5 weeks at most.

It’s also important to deal with ongoing stress or anxiety, says Eddie Reece, MS, LPC, DCC, a psychotherapist in private practice near Atlanta. “I think most people with insomnia, including me, are fairly anxious people.”

He points out to patients that “it’s not just what you’re doing during the night that matters — if you’re revved up all day until it’s time to go to bed, it’ll be difficult to get to sleep.”

Additionally, people are often unaware of how their surroundings and habits may be affecting their sleep. Amy Rothenberg, ND, a Connecticut-based naturopathic physician, asks patients with insomnia to first adopt regular sleep and wake times that they should follow every night, including weekends, and to make sure that their mattress and pillows are comfortable. If noise is a common problem, a fan or white noise machine can be helpful.

Turn Those Electronics Off!

She also advises patients to turn off all electronics at least 1 or 2 hours before bedtime. “This is extremely challenging for many people, but research now confirms that constant screen time, especially late into the evening, may interfere with the quality and quantity of sleep,” she notes.  “The light from devices will have your brain thinking it’s not time for bed. Then the stress of reading emails or watching shows adds cortisol to the bloodstream, which further interferes with sleep.”

Unplugging in the hours before bed has made all the difference for Rich Mallard, a customer service rep who used to stay glued to his laptop right up until he turned off the lights — and often ended up tossing and turning for half the night. Since he started shutting the screen down a couple of hours before bed, he says, his sleep has improved dramatically.

Dr. Rothenberg also recommends regular exercise of just about any type — walking, running, swimming, dancing, biking — which is associated with better sleep.

Apps or online resources that guide you through breathing exercises or mindfulness meditation may also help calm your mind to prepare you for a good night’s sleep. UCLA’s Mindfulness Awareness Research Center has free guided meditations you can download.

Reece teaches patients various techniques like these, and has them pick the ones they like best and practice them when they have sleep trouble. “Then, when they’re not sleeping, instead of that being a bad thing, it’s great because now they have time to practice,” he says.

He also encourages patients to focus more on rest than sleep, which can help ease the anxiety that arises from not being able to sleep. “You have much more control over resting than you do going to sleep — and it just so happens that if you rest well at night, you might just fall asleep!”

Natural Remedies to Promote Sleep

As for natural remedies, the herb valerian has long been used as a mild sedative that can help with sleep problems. “We generally recommend standardized extracts, which are available at health food stores, with 1 to 2 caps taken before bedtime,” says Dr. Rothenberg. “Valerian is gently relaxing — it won’t knock someone out like a pharmaceutical sleeping aid, and it should not cause morning grogginess.”

Another natural substance that may be helpful is melatonin, a “hormone that helps to keep biorhythms including the wake/sleep cycle in good working order.” The recommended dosage varies for each person, as some need more while others need less.

In addition, Dr. Salas offers the following tips to improve your chances of sleeping well:

  • Make your room darker. Light interferes with a person’s circadian rhythm. He recommends using lamps and dimmers in the evening, and to remove glowing bedside clocks.
  • Limit caffeine after noon.
  • Wash bed sheets every 1 to 2 weeks.
  • Create a bedtime routine. For example, take a warm shower or bath, don your PJs, and do some relaxing reading.
  • Keep your room somewhere between 65 to 69 degrees, which is an ideal range for most people. (Being too hot or too cold can interfere with sleep.)
  • Spicy or fatty meals may cause you to wake up with indigestion. Eat 3 hours before bed. Same goes for alcohol. If you’re hungry before bed, a light snack such as yogurt or cereal is okay.
  • Lastly, talk with your healthcare provider. Insomnia is interesting because while it can be a sleep disorder itself, it can also be a symptom of something else that often can be treated. If improving your sleep practices, behaviors, environment and patterns does not improve your sleep, it is time to seek medical advice.

Quick Hits: Payments from Drug Industry to Docs, Sleeping Pills Boost Fracture Risk & More

About half of US doctors have received payments of some type from pharmaceutical and/or medical device companies amounting to $2.4 billion in 2015. The results is that it encourages doctors to prescribe expensive drugs and medical devices peddled by sales representatives. Researchers analyzed data from Open Payments, a federal program that collects information on payments that biomedical companies make to physicians and hospitals. In 2015, almost 450,000 out of more than 933,000 doctors received some kind of payment, such as free meals or travel, speaking fees and other gifts. The Journal of the American Medical Association focused this week’s issue on conflicts of interests. Posted May 2, 2017. Via JAMA.

Older people who are prescribed sleeping pills like benzodiazepines and Ambien (zolpidem) have more than double the odds of a hip fracture in the first two weeks compared with non-users. Researchers assessed people over the age of 65 and found that new users of these medications experienced nearly 2.5 times the fracture rate, when compared with older people not taking them. An approximately 53% increase in fracture risk was identified in medium-term users (15 to 30 days), and a 20% increased risk of hip fracture in long-term users (30 days or more). Posted April 26, 2017. Via PLOS ONE.

The FDA approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). Rydapt is for patients that have a specific genetic mutation and will be used in combination with chemotherapy. Some common side effects of Rydapt in include low levels of white blood cells, fever, nausea and inflammation of the mucous membranes. Women who are pregnant or breastfeeding should not take the medication because it may cause fetal harm. Patients who experience signs or symptoms of lung damage should stop taking the drug. Posted April 28, 2017. Via FDA.

Next Avenue: 7 Reasons to Avoid Sleeping Pills

By Steven Findlay

A group of medicines that became wildly popular over the past 20 years ended up posing serious dangers to some of the people who took them and to public health. But they also helped millions of people get a little bit more sleep. Yes, we are talking about insomnia drugs — sleeping pills.

The declining use of such drugs is not hard to understand. Reports have focused attention for years on the risks associated with these medicines, their misuse and abuse. Research has also pointed to their general lack of effectiveness at resolving the underlying causes of chronic insomnia.

But here’s the bottom line for people who occasionally have trouble sleeping (most of us) or the unlucky 5 to 10 percent who have chronic insomnia: Don’t take these medicines at all if you can avoid it. Read here.

Consumers Wake Up to the Reality of Insomnia Pills

A group of medicines that became wildly popular over the past 20 years ended up posing serious dangers to some of the people who took them and to public health.

But they also helped millions of people get a little bit more sleep.

Yes, we are talking about the insomnia drugs doctors wrote just under 40,000 prescriptions for Belsomra in May, for example, compared to 2.6 million for zolpidem, according to IMS Health, a drug sales tracking firm.  But prescriptions for zolpidem were down from just under 3 million in December 2014.  Similar drops occurred for the two other prescription insomnia drugs.   — Ambien, now sold mostly as a generic called zolpidem, being the most widely known and prescribed. We’re also talking about Belsomra (suvorexant), the newest drug in this class and one of the most heavily advertised drugs over the last year.

After years of reports and attention to the risks associated with these medicines, their misuse and abuse, and their general lack of effectiveness at resolving the underlying causes of chronic insomnia, prescriptions for them are on the decline. And sales of Belsomra are in the dumpster.

Doctors wrote just under 40,000 prescriptions for Belsomra in May, for example, compared to 2.6 million for zolpidem, according to IMS Health, a drug sales tracking firm.  But prescriptions for zolpidem were down from just under 3 million in December 2014.  Similar drops occurred for the two other prescription insomnia drugs.

Why You Should Avoid These Meds If Possible

But here’s the bottom line for people who occasionally have trouble sleeping (most of us) or the unlucky 5 to 10% who have chronic insomnia: Don’t take these medicines at all if you can avoid it, and if you do need to take one, do so for the shortest time possible. Not more than a week or so. A few days would be better.

Why? The mediocre effectiveness of insomnia drugs coupled with serious side effects and misuse should keep them out of your medicine cabinet. Here are some facts about the  effectiveness and side effects of these medicines, as well as data on their misuse, courtesy of Consumer Reports Best Buy Drugs. Additional information was provided by Steven Woloshin, MD and Lisa Schwartz, MD, both of the Geisel School of Medicine at Dartmouth, Thomas Moore of the Institute for Safe Medical Practices, and the FDA:

  • Though studies vary, as do individual experiences, time to fall asleep after taking zolpidem and the 2 other older insomnia drugs is improved by 6 to 20 minutes compared with placebo; time staying asleep is extended by 25 to 45 minutes compared to placebo.
  • People taking Belsomra fell asleep 6 minutes faster than those taking a placebo; they stayed asleep 16 minutes longer.
  • 2/3 of people taking zolpidem use it for weeks, months or even years — a pattern of use at significant variance with the FDA and manufacturer’s recommendations of 7 to 10 days use max. And, in one analysis, 1 in 5 people who took zolpidem combined it with an opioid, increasing their risk of potentially fatal depression of the central nervous system not to mention other ill effects.
  • 2%-6% of people taking lower doses of zolpidem experience next day drowsiness, even when they had taken the drug 6 to 7 or more hours prior to waking up; 7% to 15% of people taking higher doses of zolpidem experience next day drowsiness. (Because of this side effect and its link to traffic accidents and other untoward events, the FDA in 2013 lowered the recommended initial dose.
  • 7% of people taking either the 10mg or 20mg dose of Belsomra experienced next day drowsiness, compared to 3% who took a placebo, in clinical trials involving 1,784 patients.
  • Sleep-walking or doing other activities when you are asleep like eating, talking, having sex or driving a car have all been associated with insomnia medicines, including Belsomra. So have memory lapses, and hallucinations. Generally, fewer than 1 in 10 people experience these problems.
  • 2 in every 100 people who took Belsomra experienced the very frightening side effect of temporary muscle paralysis and/or an inability to speak. Essentially, they were semi-awake but could not move or speak. This rare but extremely unpleasant potential side effect is believed to be one reason doctors have been reluctant to prescribe the drug.
  • All the insomnia medicines, including Belsomra, carry a risk of dependency. It’s not so much physical dependency, as happens with opioids or benzodiazepines like Xanax. It’s more of a psychological dependency, abetted by rebound insomnia. That’s when you stop taking the medicine and, for a while, you have even more trouble falling or staying asleep.
  • By the end of last year, the FDA had received 2,378 reports of adverse events/problems associated with Belsomra, a relatively high rate of reported events given that less than 500,000 prescriptions have been written for the drug. The most frequent problem cited was that the drug was ineffective (38% of reports). The next most frequent was sleep disturbance (27%), which included abnormal dreams, hallucinations, and sleep paralysis (59 reported episodes).

So, doctors and patients appear to be getting wise to the downside of these medicines, and they have resisted Belsomra. Though this resistance is also probably to due to its cost: $70 to $80 for 7 pills compared to $10 to $20 for 7 to 10 zolpidem pills.

While the trend suggests, at long last, more caution in prescribing these medicines, millions of prescriptions are still being written. There are many reasons for this, the main one being that 1 in 4 Americans say they have sleep problems.

Sleep Easier

If you are among such people, here’s wise advice from Consumer Reports:

transparent-green-checkmark-26 Having occasional trouble sleeping is a universal human experience. Don’t take a pill if you’ve had trouble sleeping for just a couple nights, especially if the sleep disturbance is due to job or relationship stress or a temporary life upset. This almost always resolves in time.

transparent-green-checkmark-26 Before taking a pill, try improving your sleep habits. Studies show this works. Among the techniques: Relaxation training, setting and sticking to consistent bedtimes and wake-up times, regular exercise, quitting smoking, cutting back on caffeine and alcohol in the afternoon and evening, keeping your bedroom quiet and dark and not watching TV or using a computer in bed (including a smartphone). Read a book instead.

transparent-green-checkmark-26 If you still experience problems and/or have been diagnosed with chronic insomnia (three or more nights a week of poor sleep for 8 weeks or more), try cognitive-behavioral therapy. This involves working with a therapist (possibly at a sleep clinic) to learn a new set of behaviors around sleep. Numerous studies show CBT is as effective as sleeping pills in helping people with chronic insomnia.

transparent-green-checkmark-26 If you still want to try a chemical sleep aid, try nonprescription drugs containing an antihistamine For example, diphenhydramine, the active ingredient in Benadryl, is also sold as a sleep aid under the brand names Nytol and Sominex, and as a generic), or doxylamine (Unisom and generic).  Diphenhydramine is also in Advil PM and Tylenol PM, though you should steer clear of these products unless you are also experiencing pain or fever. Don’t take any of these over-the-counter drugs for more than a few nights. And don’t take one if you are also taking any other medicine that causes sedation.

transparent-green-checkmark-26 Don’t mix any kind of sleeping pill with alcohol.  This advice applies to people of all ages, but is especially important for people over age 65, who are prone to falls and the cumulative sedative effects of multiple medicines.

Psychotherapy, Not Sleeping Pills, Best for Insomnia

Millions of Americans suffering from insomnia are quick to head to their medicine cabinets and pop an Ambien to get a good night’s sleep. But there’s a better way to meet Mr. Sandman that doesn’t come with the side effects of taking a sleep drug: psychotherapy.

A mix of talk therapy and education about proper sleep techniques, known as cognitive behavioral therapy for insomnia (CBT-I), is better than reaching for a pill for chronic insomnia sufferers, according to new guidelines out from the American College of Physicians (ACP). Chronic insomnia is considered having sleep difficulties that happen at least 3 times a week for a minimum of 3 months that can impair activities.

Although many with insomnia are quick to ask their doctor for a sleeping med prescription, those drugs can lead to a host of side effects, including excessive sleepiness, dizziness, lightheadedness and a “drugged” feeling. They are only supposed to be taken for a relatively short period, usually 4 or 5 weeks at the most.

“Although we have insufficient evidence to directly compare CBT-I and drug treatment, CBT-I is likely to have fewer harms,” ACP President Wayne J. Riley, MD, said in a statement. “Sleep medications can be associated with serious adverse effects.”

CBT-I is designed to change the behavior of insomniacs, thoughts about sleep and what they do while they are awake in order to promote better sleep. They are also required to keep sleep logs. The techniques can be done through individual or group therapy sessions, telephone, on the Internet or self-help books.

Some of the specific techniques involved include stimulus control (establishing consistency in sleep patterns by associating sleep with the bed and bedroom, aka, only going to sleep when tired), sleep restriction (limiting time in bed to sleep only) and relaxation training (controlling bedtime thought patterns that may impair sleep).

Although CBT-I can take several weeks to master as opposed to getting the instant relief of swallowing a pill, experts say that the lessons learned can be applied long after the therapy sessions are over.

The ACP came out with a second, albeit weaker, recommendation to follow when CBT-I doesn’t seem to work: that doctors weigh the benefits, risks and costs of short-term use of sleep meds in deciding whether to add it to an insomniac’s treatment plan.

New users of sleeping pills have more car crashes

Sedative sleeping pills can nearly double the risk for car accidents among new users compared with nonusers, a University of Washington study suggests. Researchers looked at prescription records and motor vehicle crash records of more than 400,000 Washington state drivers who had a drug benefit in the Group Health Cooperative insurance plan. Researchers found an increased risk of crashes for people taking Restoril (temazepam), Desyrel (trazodone) or Ambien (zolpidem). Via CBS News. Posted June 12, 2015.

–Alanna McCatty

Anxiety and sleeping pills ‘linked to dementia’

A study, published in the British Medical Journal, found that past benzodiazepine use for 3 months or more was linked to a 51% increased risk of dementia. The study involved about 2,000 cases of Alzheimer’s disease in adults aged over 66 who had been prescribed benzodiazepine, the main ingredient in Xanax and Valium among other anti-anxiety medications. They were compared with about 7,000 healthy people of the same age. An increased risk was found in those on benzodiazepines.

The question that remained was whether benzodiazepine increased the risk of dementia, or if the underlying anxiety being treated with the medication is a sign that dementia is underway. Via BBC and Harvard Health Publications. Posted September 12, 2014.
–Alanna McCatty

Project Deceptive? Lunesta Claims Short of Reality

The media frenzy around the Kerry Kennedy trial reminded me of a conversation that my husband and I had a short time ago. We had seen a 15-second advertising spot at least a dozen times in the past couple of weeks before my husband finally asked, “What is Project Luna?”

The animated ad has graceful neon-green butterflies flying out and above homes in the nighttime. The view pulls back to reveal first a town at night and then the entire U.S. with lights ablazing in the dark. Winsomely it begs, “Project Luna, join us.” The appeal is on the screen for 4 seconds and if you read fast, you will see it is sponsored by Sunovion.

Neither my husband nor I had any idea what was being advertised, so I pulled out my handy tablet and Googled Project Luna. Up popped an animated website with similar, soothing graphics of green nighttime moths. The copy claimed “Because we understand healthy sleep habits may work alongside medication to manage insomnia.” Immediately to the right of this headline was an offer for Lunesta at $0 (yes, zero dollars) and many of the legal required disclaimers in small text below. With just a click or 2, but not on the front page, were tips for better sleep hygiene.

I don’t like teaser ads. I had no idea it was sending me to a website designed to sell me a sleep aid. I am very uncomfortable with advertisements that don’t clearly state the name of the drug or even the name of the medical condition. It allows the pharmaceutical company to create an enticing environment that draws the consumer in without the consumer being forewarned. A siren call of calming, soothing butterflies lulling the consumer.

The website itself is beautiful, it’s easy to navigate and pushes the drug and has pharmacologic information easily available. It has non-drug suggestions. I’d hold this up as a model of good pharma advertising except for one thing. The drug does very little — almost nothing — to aid sleep.

The website claims that “In clinical studies LUNESTA was proven effective to help the majority of patients with insomnia fall asleep quickly and stay asleep for up to 7 hours. Individual results may vary.”

A little research showed me this is not exactly true. A clear, consumer-friendly “Drug Facts” review of the study presented to the FDA to base approval upon is available online and was developed by doctors Steve Woloshin, H. Gilbert Welch and Lisa Schwartz, all affiliated with the Center for Medicine, the Media and the Public at the Dartmouth Institute for Health Policy and Clinical Practice.

The study included 788 adult insomniacs, half were given a sugar pill and half of the adults got Lunesta to take daily for a total of 6 months. The sugar-pill people fell asleep within 45 minutes each night, the Lunesta takers within 30 minutes. A net gain of 15 minutes, not much difference. The definition of insomnia includes sleeping less than 6 1/2 hours per night. Sugar-pill takers got on average 5 hours and 45 minutes. Lunesta takers got 6 hours and 22 minutes. That is definitely better, but Lunesta did not solve the insomnia: the patients did not exceed 6 1/2 hours. Lunesta also did not get the majority of users to 7 hours of sleep as claimed online. Not to be overlooked, more Lunesta takers reported many more side effects, such as a metallic taste in the mouth, than sugar pill users.

What about all the bad news on sleeping meds and amnesiac activities? Ambien and Lunesta have a different main ingredient. However, the FDA is requiring both of them to supply extra patient information about possible side effects of sleep walking, eating, driving…you know the whole Kerry Kennedy driving under the influence issue (and before her, Patrick Kennedy who drove to the White House while asleep and under the influence of Ambien.)

From The New York Times: “Although most of the reports of sleep-driving and sleep-eating have involved Ambien, the agency (the FDA) concluded that the behavior can be caused by any of the sleeping pills.”

“One sleep expert, Dr. Mahowald of Minnesota, said that Ambien had received the most publicity because it was the most widely used. But ‘there’s no question that any of the sedative hypnotics can do this,’ he said,” the New York Times reported.

Maha Ahmad, MD, MMSc, Associate Director of the Sleep Disorders Institute in New York, reviewed side effects of “hypnotics” as the drug category is called in a recent Q&A. In addition to side effects listed above, she warned of a higher risk of falling in the elderly.

I don’t have insomnia, but the times I’ve been sleep-deprived have alerted me to what a negative effect insomnia must have on a life. However, Lunesta doesn’t “fix” insomnia. It has more side effects than a sugar pill. Lunesta users are risking Ambien-like side effects.

I’m not convinced that the benefits of Lunesta outweigh the risks.