Anxiety About Sleep: Could Herbal Medicines Help?

“I have 5 years of anxiety about not being able to sleep to overcome,” began a query I received a month ago. “Once triggered, it is difficult to stop this downward spiral and sleep.”

Without a doubt, anxiety about sleep is one of the hardest aspects of insomnia to beat. Cognitive behavioral therapy for insomnia can help to reduce sleep-related anxiety, as can other adjunctive therapies. But here’s an alternative treatment that might lead to calmer nights: plant-based medicines found to be effective for anxiety.

Insomnia-driven sleep anxiety & herbal medicines“I have 5 years of anxiety about not being able to sleep to overcome,” began a query I received a month ago. “Once triggered, it is difficult to stop this downward spiral and sleep.”

Without a doubt, anxiety about sleep is one of the hardest aspects of insomnia to beat. Cognitive behavioral therapy for insomnia can help to reduce sleep-related anxiety, as can other adjunctive therapies. But here’s an alternative treatment that might lead to calmer nights: plant-based medicines found to be effective for anxiety.

Anxiety About Sleep: How It Develops

Anxiety about sleep is learned, and the learning is largely unconscious. The anxiety may develop during a stressful situation when you’re having trouble with sleep. You might be in a tight spot at work or in the midst of a contentious divorce. You might be worried about a new breast lump or how to make ends meet for the next 6 months.

Whatever the stress, it keeps you up at night and soon it extends to worry about sleep itself. What happens if you can’t get enough sleep? What if you’re too sleep deprived to meet the next work deadline? What negative effects will insomnia have on your long-term health?

Once anxiety becomes focused on sleep, it’s hard to root out. The triggers may remain unknown: a darkening sky, evening birdsong, the bed itself. A simple glance at the clock can set off alarms in your head. (“It’s already midnight and I’m still too wired to sleep!”) And feelings of anxiety — muscle tension, a rapid heartbeat, bodily warmth and perspiration — can sabotage sleep. If night after night this pattern is reinforced, no wonder it’s hard to break.

Herbal Remedies for Anxiety

Anxiety about sleep is situational, and therapies shown in clinical trials to lower sleep-related anxiety — cognitive behavioral therapy for insomnia (CBT-I), yoga, and mindful stress reduction — are probably the most reliable paths to relief. Exercise has stress-reducing effects as well. But GABA is the neurotransmitter most prominently associated with calming the brain, and plant-based medicines that act on the GABA system may be helpful, too.

A team of Australian researchers recently conducted a systematic review of plant-based medicines for anxiety including both clinical (human) and preclinical (in vitro and animal) studies. Following are herbal medicines the evidence shows are mostly likely to have anxiety-reducing effects.

Kava (Piper methysticum)

Kava, native to the South Pacific, is the hands-down winner when it comes to the amount of evidence amassed in support of its effectiveness as an herbal remedy for anxiety. “The number of positive findings from human studies of P. methysticum within randomised, well-controlled trials . . . supports its use as a treatment for various anxiety disorders and associated symptoms, demonstrating broad clinical utility,” the authors write.

The main active ingredients in kava are called kavalactones. Kava supplements contain specific concentrations of these kava extracts and are available in tablet form or as a tincture. See my earlier blog post for an in-depth treatment of kava’s effects on anxiety and sleep and possible adverse effects.

Valerian (Valeriana officinalis)

Valerian, native mainly to Europe, looks like the next most-promising herbal with anxiety-reducing properties. The root extract has been used as a sedative and anti-anxiety medicine for millennia. Tests on human subjects have found that valerian is particularly effective at reducing subjective feelings of anxiety that arise in stressful situations.

Two human studies suggest that valerian doesn’t negatively impact psychomotor and cognitive performance the way the benzodiazepines (medications often prescribed to reduce anxiety) tend to do. So regarding safety, valerian has a relatively clean bill of health.

Passion flower (Passiflora incarnata)

Passion flower, native to the Americas, has been used for millennia as an herbal remedy for anxiety and trouble sleeping. Investigators in 4 clinical trials studied its anxiety-reducing effects in patients who were about to undergo surgery. Results showed that passion flower significantly reduced anxiety in comparison with placebo. In fact, its effects were similar to those of anti-anxiety benzodiazepine medications, including, in one of the studies, reductions in blood pressure and heart rate.

Two more studies involving use of passion flower in people with anxiety disorders showed the herb’s anti-anxiety effects were similar to those produced by benzodiazepines.

Ashwagandha (Withania somnifera)

Ashwagandha, traditionally used in Indian Ayurvedic medicine, is a plant in the nightshade family. (It’s sometimes called Indian ginseng.) Ashwagandha powder, prepared from the root, leaves, or whole plant and taken orally, has been prescribed to reduce anxiety and improve sleep for centuries. Today it’s available as a dietary supplement in powder, capsule, and tablet forms.

In 5 clinical trials, ashwagandha was found to have at least one significant anti-anxiety, anti-stress benefit compared with control conditions. Another very recent clinical trial involving participants with chronic stress compared the use of 600 mg of ashwagandha extract daily to placebo capsules taken over 8 weeks. Significantly greater stress reduction occurred with the extract, as did decreases in salivary cortisol (a biomarker of stress and anxiety). See my earlier blog post for more information on ashwagandha’s effects on stress, anxiety, and sleep.

Chamomile (Matricaria recutita)

Chamomile, a flowering plant in the daisy family, is plentiful throughout Europe and Asia. It’s been used for millennia, mainly as a tea, for its calming and sedative effects. In an 8-week clinical trial in patients with generalized anxiety disorder (GAD), participants taking 220 mg of chamomile 1 to 4 times daily showed significantly greater reductions in anxiety than controls. In another 8-week study involving patients with GAD taking a 500-mg capsule of chamomile 3 times a day, 58% of the participants showed significant reductions in anxiety.

In a strange twist, a study of the effects of chamomile in 34 patients with insomnia found that chamomile was effective at improving sleep and daytime stamina but did not reduce symptoms of anxiety.

Final Caveat

If you plan to try herbal medicine as an alternative treatment for anxiety about sleep, consult a naturopath or other health professional about the correct dose. At least do some research yourself.

And don’t expect momentary relief. Herbal medicines, said Jerome Sarris, an author of the Australian review paper whom I also interviewed for The Savvy Insomniac, “generally take longer to work, whereas some people just want that quick fix. I think they may have more of a role in long-term assistance.” So use herbal medicines as indicated and wait at least a few weeks to start looking for results.

Off-Label Prescribing for Insomnia: What to Expect

Several drugs approved for insomnia are in the doghouse these days, and physicians are doing a fair amount of off-label prescribing. What medications should we expect to be prescribed in lieu of zolpidem (Ambien) and temazepam (Restoril)?

Using a “translational approach,” McGill University researchers have reviewed a host of medications with sedative properties and found the evidence base for some is stronger than for others. Here are the drugs they’ve found are most likely to work.

Insomnia treated with sleeping pill substituteSeveral drugs approved for insomnia are in the doghouse these days, and physicians are doing a fair amount of off-label prescribing. What medications should we expect to be prescribed in lieu of zolpidem (Ambien) and temazepam (Restoril)?

Using a “translational approach,” McGill University researchers have reviewed a host of medications with sedative properties and found the evidence base for some is stronger than for others. Here are the drugs they’ve found are most likely to work.

Why Not Stick With the Tried and True?

Z-drugs such as zolpidem and benzodiazepines such as temazepam may be fine for short-term or occasional use. But lots of people who take these sleeping pills go on to become chronic users.

This can cause problems. People who take a Z-drug or a benzodiazepine nightly for months and years often experience adverse effects: a decrease in deep (or slow-wave) sleep and/or cognitive and motor impairments the next day. Some develop drug dependency.

The Off-Label Prescribing Dilemma

So where’s the next generation of sleeping pills in line to replace the ones we’re using now? A few new drugs are in the pipeline, but none I’m aware of are going up for FDA approval soon. As often happens, we’ve got to fall back on drugs already approved to treat other health problems. It’s perfectly legal for doctors to prescribe such drugs off label as treatment for insomnia.

The problem lies in knowing which other drug(s) to choose. Medications approved for insomnia have demonstrated their efficacy in at least two randomized clinical trials (RCTs) conducted on people with insomnia (and no other related condition). Compared with placebo, they’ve been found to significantly improve sleep. Medications approved for other health conditions—such as depression, anxiety, or neuropathic pain—may have known sedative properties. But in many cases they haven’t been tested for efficacy on people with simple insomnia.

A Translational Approach

In an in-depth review paper published this month in Pharmacological Reviews, the McGill University researchers propose instead using a translational approach to evaluate these drugs for efficacy in treating insomnia. This involves integrating what basic scientific research has shown about a drug’s pharmacology and mechanism of action with clinical data and current medical practice.

Using this approach, the researchers went on to identify medications most likely to serve as effective alternatives for Z-drugs and benzodiazepines. Here they are:

Drugs That Act on the Melatonin System

1. Prolonged-release melatonin (PRM): FDA-approved dietary supplement sold over the counter in the United States; sold as a prescription drug (2 mg/day) in Europe. “Good evidence,” based on 4 RCTs, that PRM is effective for insomnia disorder in adults over age 55 (particularly in reducing time to sleep onset). There’s no evidence that PRM is effective for younger adults with insomnia. (Caveat: The quality control of dietary supplements sold in the United States is not nearly as reliable as the control of prescription medications. Your physician may be able to steer you toward a reliable brand.)

2. Ramelteon (Rozerem): FDA-approved drug for treatment of sleep onset insomnia. “Strong evidence,” based on 2 meta-analyses, that the drug reduces subjective time it takes to fall asleep but no evidence that it helps people sleep longer.

3. Agomelatine (Melitor): Not available in the United States but approved for treatment of major depressive disorder in Canada and Europe. “Good evidence,” based on 1 review and 2 RCTs, that this drug reduces sleep latency in people with depression. Unlikely to improve sleep in people with simple insomnia.

A Drug That Acts on the Orexin System

4. Suvorexant (Belsomra): FDA-approved drug for treatment of insomnia disorder. “Strong evidence,” based on 2 systematic reviews, that the drug reduces insomnia symptoms at doses of 15 mg and higher. It purportedly increases total subjective sleep time and decreases subjective time to sleep onset. (Caveat: Because this drug is a relative newcomer, less is known about its real-world effectiveness and actual side effects. For more information, read my earlier post about Belsomra and take a look at the reader comments.)

Sedating Antidepressants

5. Low-dose doxepin (Silenor): FDA-approved drug for treatment of sleep maintenance insomnia that acts on the histamine system. “Strong evidence,” based on 1 systematic review, that this drug enhances sleep maintenance by reducing nighttime wake-ups. It has not been found to cut down on time to sleep onset.

6. Trazodone: FDA-approved drug for treatment of depression. At low doses, commonly prescribed off label for treatment of insomnia. It acts on the histamine, serotonin, and catecholamine systems. “Good evidence,” based on 2 RCTs, that trazodone reduces insomnia symptoms in people who are taking selective serotonin reuptake inhibitors (SSRIs) to manage depression. This is the only conclusion drawn by the McGill researchers about trazodone. It does not account for the drug’s great popularity with physician prescribers, who for decades have been prescribing trazodone for insomnia rather than Z-drugs and benzodiazepines.

More on Trazodone

So I looked at another paper, this one a systematic review of trazodone for insomnia published in Innovations in Clinical Neuroscience in August 2017. From a pool of 45 studies (the inclusion criteria were evidently less stringent for these researchers than for the McGill researchers, who reviewed 16 studies of trazodone), the second team of researchers concluded that trazodone “is a generally safe therapeutic that has been repeatedly validated as an efficacious treatment for insomnia, particularly for patients with comorbid depression,” with some evidence that it decreases sleep latency, increases sleep duration, and improves sleep quality. Side effects, which may show up in people taking doses higher than 100 mg, include daytime sleepiness, headache, and hypotension, increasing the risk of falls.

The evidence base for trazodone’s effectiveness as a drug for people with simple insomnia is sparse yet suggestive of similar benefits, the second research team reports. (Results of a recent 6-week clinical trial comparing 3 active insomnia treatments—behavioral therapy, zolpidem, and trazodone—are not yet available. Stay tuned.)

An Anticonvulsant Drug

7. Pregabalin: FDA-approved drug for treatment of neuropathic pain, seizures, and fibromyalgia. There is “good evidence,” based on 2 review papers, that pregabalin is effective in reducing symptoms of insomnia in generalized anxiety disorder. There is also “good evidence,” based on 1 review, that the drug is effective in reducing symptoms of insomnia in fibromyalgia. But no evidence base for pregabalin as a treatment for simple insomnia exists.

The medical treatment of insomnia has always been problematic, even more so in the past than today. While your physician may be reluctant to keep writing prescriptions for zolpidem, other, possibly safer medications may be available when behavioral treatments for insomnia don’t suffice.

Transitioning to Menopause? Don’t Give Up on Sound Sleep

I often hear sleep complaints from women approaching menopause. Hot flashes and mood swings are other common complaints. What can be done to improve sleep and reduce perimenopausal symptoms?

The key, say authors of a review paper published this year, is to use a variety of approaches based on individual women’s symptoms, history and needs.

Insomnia and hot flashes can be relieved with multi-pronged treatmentI often hear sleep complaints from women approaching menopause. Hot flashes and mood swings are other common complaints. What can be done to improve sleep and reduce perimenopausal symptoms?

The key, say authors of a review paper published this year, is to use a variety of approaches based on individual women’s symptoms, history and needs.

Sleep Problems in the Menopausal Transition

The transition to menopause begins 4 to 6 years before menstruation stops (the median age for menopause is 51 years). It’s a time of fluctuating reproductive hormone levels. Not all women suffer ill effects during this period but many do.

Sleep problems are one of the most common complaints, reported by up to 56% of women approaching menopause, say authors of the review, published in the journal Nature and Science of Sleep. In turn, trouble sleeping often compromises midlife women’s quality of life, mood and productivity.

There’s an uptick in sleep-disordered breathing (sleep apnea) among women transitioning to menopause. There’s also an uptick in insomnia. A study involving 982 perimenopausal women interviewed by phone found that 26% had symptoms qualifying them for a diagnosis of insomnia disorder as medically defined.

Not Just in Our Heads

Fluctuating levels of hormones—follicle-stimulating hormone, estradiol (an estrogen) and progesterone—likely play a role in insomnia that occurs during the menopausal transition. Hot flashes, too, which typically emerge as estrogen levels decline, are associated with poorer reported sleep quality and chronic insomnia.

As for objective evidence of menopausal sleep problems, results of population studies of midlife women involving polysomnography (PSG) are inconsistent. But in a recent study published in Psychoneuroendocrinology, investigators found “stark differences in PSG measures in women with, relative to women without, insomnia disorder developed in the menopausal transition.”

Women who developed insomnia during the menopausal transition

  • had poorer sleep efficiency
  • experienced more wakefulness after sleep onset
  • had shorter total sleep time, with 50% sleeping less than 6 hours
  • were more likely to have hot flashes, which predicted their number of awakenings per hour of sleep.

A Role for Depression and Stress

Symptoms of depression typically increase during the menopausal transition. Depression and insomnia are closely linked, with depression sometimes preceding insomnia and insomnia sometimes leading to depression. The results of one interesting study suggest that trouble falling asleep at the beginning of the night is associated with anxiety while nonrestorative sleep is linked to depression.

Chronic exposure to stress could be another factor in midlife women’s greater susceptibility to insomnia. And during the transition to menopause, traits associated with insomnia—increased tendency toward rumination, anxiety, generalized hyperarousal, stress reactivity, and neuroticism—are similar to tendencies predictive of hot flashes and other perimenopausal symptoms.

Treatments for Insomnia in the Menopausal Transition

Since insomnia in the menopausal transition is likely due to many factors, it’s challenging to treat. The reviewers recommend “flexible and individualized” treatments for insomnia depending on each woman’s current symptoms and history.

Hormone Therapy

Hormone therapy generally improves sleep quality in women who experience hot flashes during the transition. It may be a good option if, based on a woman’s history and health concerns, the overall potential benefits outweigh the risks. The reviewers note that abrupt discontinuation of hormone therapy is associated with hot flash relapse, which could in turn lead to insomnia.

Non-Hormonal Pharmacological Therapies

Sleeping pills, which are generally prescribed for short-term or intermittent use, are not a front-line treatment for insomnia in perimenopausal women. Taken nightly over time, many sleeping pills degrade sleep quality and have other negative effects. Following are the medications the reviewers suggest considering for perimenopausal women with insomnia and hot flashes:

  • Low-dose selective serotonin reuptake inhibitors—such as citalopram (Celexa) and escitalopram (Lexapro)—and low-dose serotonin norepinephrine reuptake inhibitors—such as duloxetine (Cymbalta) and venlafaxine (Effexor XR). Note that discontinuation of SSRIs is associated with hot flash relapse, which could lead to insomnia.
  • Gabapentin, shown to improve sleep quality in perimenopausal women with hot flashes and insomnia.
Non-Pharmacological Therapies
  • Cognitive behavioral therapy for insomnia (CBT-I) is the overall gold standard in drug-free treatments for insomnia. In a randomized clinical trial recently conducted on peri- and postmenopausal women experiencing at least 2 hot flashes daily, women who underwent CBT-I “had significantly greater reduction in insomnia symptoms and greater improvements in self-reported sleep quality” compared with controls. The improvements were maintained at 6 months after treatment.
  • Soy isoflavones—phytoestrogens found mainly in legumes and beans—have been shown in randomized controlled trials to reduce menopausal symptoms, including self-reported sleep disturbance. They’re available as dietary supplements.
  • High-intensity exercise and yoga are reported by the reviewers to be modestly beneficial in reducing menopausal symptoms and improving sleep.

Because many factors can combine to disrupt sleep in the period leading up to menopause—sleep disorders, mood disorders, medical conditions, and life stressors—no one-size-fits-all treatment will improve sleep and minimize menopausal symptoms. Instead, the reviewers recommend a multi-pronged approach to treatment based on individual women’s needs.

Anniversary Book Giveaway Marks Change in Blog

It’s time for a couple of announcements: The Savvy Insomniac came out four years ago today and we’re giving away 10 copies of the book to mark the occasion. Read on to find out how to get one yourself!

Announcement No. 2: I’ve been blogging weekly about insomnia for five years and now, starting in October, I’ll be posting once a month. I’m as committed as ever to offering news and perspective on issues related to sleep and insomnia. But other projects are calling and taking more time.

Here are the giveaway details. After that, a summary of popular blog topics you’ll hear more about in the future.

Still blogging about insomnia—now, once a month

It’s time for a couple of announcements: The Savvy Insomniac came out four years ago today and we’re giving away 10 copies of the book to mark the occasion. Read on to find out how to get one yourself!

Announcement No. 2: I’ve been blogging weekly about insomnia for five years and now, starting in October, I’ll be posting once a month. I’m as committed as ever to offering news and perspective on issues related to sleep and insomnia. But other projects are calling and taking more time.

Here are the giveaway details. After that, a summary of popular blog topics you’ll hear more about in the future.

Book Giveaway

First, heartfelt thanks to those of you who follow my blog. It’s one thing to visit a website now and then but quite another to sign up for news from a blogger who posts a 600- to 800-word story every week! Your interest in insomnia and insomnia treatments must be as deep and personal as mine.

For all the blogging I’ve done about sleep and insomnia, though, The Savvy Insomniac is the best and most comprehensive writing I’ve done on the subject. Anyone living in the US who hasn’t got a copy and wants one can use the contact form to let me know. The first 10 people who contact me with a question about sleep or insomnia (something you wonder about but haven’t found much information about) will get a copy of The Savvy Insomniac free of charge.

Don’t forget to include your mailing address. Overseas shipping rates are so exorbitant that I can’t ship books abroad. But inexpensive e-books continue to be available through Amazon and other online booksellers.

Here, now, are the blog topics most popular with Savvy Insomniac readers. Count on hearing more about them in the months ahead.

Insomnia Relief in the Form of a Pill

Sleeping pills don’t get great press these days, but they have great interest for Savvy Insomniac readers. Posts about Belsomra, the newest sleeping pill approved for the treatment of insomnia, consistently get the most views. Belsomra acts as a sedative by blocking transmission of orexin, a neurochemical that promotes arousal. Other orexin-blocking sleeping pills are in the works. I’ll write about them if and when they’re approved by the FDA.

Posts about sedating antidepressants are also popular. Since many sleeping pills have undesirable side effects, persistent insomnia is sometimes treated with low doses of a sedating antidepressant. Doxepin has been approved as Silenor for treatment of sleep maintenance insomnia. The others (trazodone, mirtazapine, amitriptyline) have not been sanctioned by the FDA as effective for insomnia. They do, however, have sedative properties.

Melatonin supplements are also of high interest to readers, especially in timed-release formulations. But melatonin is not a sleeping pill. Its usefulness lies in its ability to shift the timing of sleep. Melatonin is sometimes recommended to night owls whose daytime schedules make it necessary to go to sleep earlier than they would following their natural inclinations. It also helps lessen jet lag.

Insomnia: What’s Your Flavor?

Posts on the different types of insomnia are the next most visited category. Since the underlying causes of insomnia disorder remain unknown, insomnia is usually classified based on the symptoms people report.

Psychophysiologic (or psychophysiological) insomnia is the most common insomnia diagnosis given to those of us who report trouble sleeping at night and daytime impairments. Symptoms are both physiological (bodily tension and warmth, for example) and psychological (anxiety about sleep). Cognitive behavioral therapy (CBT) is now the first-line treatment for psychophysiologic insomnia.

A diagnosis of paradoxical insomnia may be made following a sleep study showing a large discrepancy between how much time a person reports sleeping and how much sleep is recorded on the polysomnogram (the test in the sleep lab). Treatment options vary and there’s no clear consensus on which works best.

Sleep Restriction for Insomnia Relief

Sleep restriction therapy comes in for a close third topic of interest to Savvy Insomniac readers. Offered as part of CBT-I or as a standalone therapy, sleep restriction has been found in research to improve several aspects of sleep.

Its appeal to readers of this blog may have to do with the sheer number of posts I’ve written on the topic (10) and the fact that it worked so well for me. Combined with daily exercise, sleep restriction helped me regularize my sleep and overcome my sleep anxiety. Invaluable gains, to me.

Seasonal Insomnia

Insomnia that varies seasonally is another topic that draws lots of readers. Environmental factors that occur in the spring and summer—too much light and too much heat—can easily interfere with falling and staying asleep.

Insomnia that starts in the fall and continues through the winter may be driven by other environmental factors. Lack of sunlight or other bright light is usually the culprit. Lack of vitamin D may be another factor. Expect to see an update on this topic coming fairly soon.

Don’t see a topic that interests you here? Use the contact form to ask a question about a topic that does interest you, and receive a free copy of The Savvy Insomniac.

And here’s a last request: please like and share blog posts you feel are helpful on Facebook, Twitter, and other social media. This will help The Savvy Insomniac blog remain discoverable to other insomnia sufferers looking for a better night’s rest.

How Much Melatonin Is Really in That Supplement?

Supplementary melatonin is the fourth most popular natural product used by adults in the United States and the second most popular given to children.

But supplements like melatonin are not subject to the same quality controls as prescription medications. A new study of melatonin sold over-the-counter shows that information on the label often does not reflect the content of the product.

Melatonin content may differ from amount listed on labelSupplementary melatonin is the fourth most popular natural product used by adults in the United States and the second most popular natural product given to children. It can change the timing of sleep, ease jet lag, and help night owls shift to an earlier sleep schedule. Occasionally it’s used to correct a melatonin deficiency, or for insomnia (although for insomnia it’s unlikely to yield much benefit).

But supplements like melatonin are not subject to the same quality controls as prescription medications. A new study of melatonin sold over-the-counter shows that information on the label often does not reflect the content of the product. Here are the details:

Testing for Melatonin and Serotonin

The researchers tested the contents of 30 different melatonin supplements sold in Canada (likely similar to melatonin sold in the United States). Among them were products with 16 different brand names (the names were not published), in 5 different strengths, and in 7 different formulations, some containing herbal additives and others without. They wanted to see how closely the amount of melatonin listed on the label matched the melatonin content of the actual supplement.

They also screened for serotonin. Serotonin is a precursor of melatonin found in the herbal extracts with which commercial melatonin is often combined.

Variation in Melatonin Content

Holy cow! The actual melatonin content of the supplements varied quite a lot from the content listed on the labels. Some labels overstated the amount of melatonin contained in the product. The worst offender here was a capsule listed as containing 3 mg of melatonin that actually contained about 0.5 mg.

Other labels greatly underrepresented the amount of melatonin in the product. The worst offender here was a chewable tablet listed as containing 1.5 mg of melatonin that actually contained nearly 9 mg. (This is particularly concerning since chewable tablets are most often taken by children.)

Not only was the melatonin content of the product off by more than 10% of the listed content in about 71% of the products tested. As shocking as this may seem, the melatonin content varied widely from lot to lot of the same product. While the first lot of the chewable tablets cited above contained nearly 9 mg of melatonin, the second lot contained only 1.3 mg. That’s a variation of 465%.

Variation Could Be a Problem

Does the dose of melatonin you take matter? To some extent, yes, say the authors of a commentary on the study. Suboptimal doses might be ineffective. Taking too low a dose might lead you to believe melatonin didn’t work when a higher dose would.

Higher-than-advisable doses could lead to undesirable side effects. Too high a dose would be risky for people taking medications that interact with melatonin, or those who are pregnant or have diabetes. And the long-term effects of supplementary melatonin on prepubertal children are still unknown.

Overall Conclusions

So what are we to do with this information in light of the fact that the researchers haven’t revealed the names of the products they studied? Here’s a summary of what they learned, which, if you take or are contemplating taking melatonin, is worth consideration.

  • The least variable products overall were those containing the simplest mix of ingredients: the tablets or sublingual tablets with melatonin added to a filler. Apparently, added herbal extracts tend to make products more variable.
  • Except for the chewable tablet cited above, capsules generally showed the greatest lot-to-lot variability in melatonin content. (However, the melatonin content of some capsules was within 10% of the content listed on the label).
  • Unexpectedly, the three liquid products tested showed fairly high stability and low lot-to-lot variability.
  • The melatonin content of products listed as containing 1 or 1.5 mg of melatonin was quite a bit more likely to diverge from what was claimed than were products listed as containing higher doses. Products purportedly containing 1.5 mg of melatonin were also quite a bit more variable from lot to lot.

Unlisted Serotonin

Eight of the 30 products tested contained unlisted serotonin. While the presence of serotonin is hard to explain in supplements containing just melatonin and a filler, it might be expected in supplements containing herbal extracts. In one such product, a capsule listed as containing 3 mg of melatonin plus lavender, chamomile, and lemon balm, the serotonin content was assessed at 74 micrograms.

Serotonin raises significant health concerns if taken in excess, the Canadian authors say. It can lead to a condition called serotonin syndrome, which can be mild or fatal and “exacerbated by interactions with other medications, such as selective serotonin reuptake inhibitors and the analgesic tramadol.”

I’d like to see the content of supplementary melatonin sold in the U.S. tested and reviewed by brand and formulation. ConsumerLab? Otherwise for people using over-the-counter melatonin (or interested in trying it) it’s a kind of Wild West situation when it comes to knowing which brand to buy. Pharmacists and doctors who prescribe melatonin may be better informed. Comments?

Lifelong Insomnia? Don’t Give Up on It Yet

Have you had insomnia all your life? Have your parents said you were a poor sleeper even as a baby?

Trouble sleeping that starts early in life is called idiopathic insomnia. If insomnia is still the black box of sleep disorders, then idiopathic insomnia is the little black box inside the black box.

Here’s what is known about the disorder and options for management.

Lifelong insomnia can be treated by sleep specialist or therapistHave you had insomnia all your life? Have your parents said you were a poor sleeper even as a baby?

Trouble sleeping that starts early in life is called idiopathic insomnia. If insomnia is still the black box of sleep disorders, then idiopathic insomnia is the little black box inside the black box.

Here’s what is known about the disorder and options for management.

What Is Idiopathic Insomnia?

Idiopathic insomnia begins in childhood, sometimes at or soon after birth. Trouble falling or staying asleep or reduced sleep duration is pretty much a nightly affair regardless of situational changes. The disorder is uncommon, affecting less than 1% of the population.

There is no identifiable cause. The presumption is that idiopathic insomnia is driven mainly by biological factors, and at least some of them are probably inherited. Abnormalities in the circadian system or the homeostatic process may be involved and/or there may be a problem in the circuitry controlling sleep and waking in the brain.

A Chronic Sleep Disorder, but How Well Defined?

Idiopathic insomnia is a chronic sleep disorder with familiar insomnia symptoms:

  • Trouble falling or staying asleep, or sleeping long enough, for more than 3 months despite adequate sleep opportunity
  • Daytime distress and impairment, including reduced stamina, low mood, and trouble thinking and learning

Research on the defining features of idiopathic insomnia is mixed. On one hand are a few studies showing significant differences between people with idiopathic insomnia (IdI) and those with psychophysiological insomnia (PI), the garden-variety insomnia that typically develops later in adolescence or adulthood. PI is often triggered by a stressful event; situational factors do not figure in IdI. PI is said to persist mainly due to psychological and behavioral factors that develop in response to poor sleep: conditioned arousal in bed, poor sleep hygiene (going to bed early to catch up on sleep, for example), and anxiety about sleep. Psychological factors are less typical in IdI.

On the other hand is research showing no major differences between PI and IdI when assessed by polysomnography (the overnight test in the sleep lab) or by self-report of psychological symptoms. Research suggests that arousal levels are higher among people with IdI than in people with other kinds of insomnia, though, leading some sleep experts to speculate that IdI is simply a more severe manifestation of PI.

What Can Be Done?

Without scientific certainty about the causes of IdI or whether the disorder is distinct from other kinds of insomnia, IdI is best treated on a case-by-case basis by a sleep specialist. Following are options for treatment.

Especially if a person with IdI has misconceptions and/or anxiety about sleep,

  • Cognitive behavioral therapy for insomnia (CBT-I) may help. CBT-I typically consists of two behavioral components—stimulus control therapy and sleep restriction therapy—and a cognitive component designed to decrease psychological barriers to sleep. Sometimes just changing your attitude about sleep can bring about demonstrable sleep improvements.
  • Acceptance and commitment therapy (ACT) may help. ACT focuses on building mindfulness skills so that, rather than trying to suppress, manage, and control emotional experiences, people develop psychological flexibility and learn to behave in ways that reflect their values and increase well-being. This approach, too, can change the way you feel about sleep and in the process improve your sleep.

If round-the-clock hyperarousal is driving IdI, then therapies designed to decrease arousal may help.

  • Regular, moderate-to-vigorous exercise—activities such as aerobics, calisthenics, biking, running, and weight-lifting—has been shown in recent studies to increase total sleep time and decrease levels of cortisol (a stress hormone).
  • Yoga, too, has been shown to decrease feelings of arousal and promote stress tolerance.

Medication for Idiopathic Insomnia

The issue of sleeping pills for chronic insomnia is increasingly fraught. Many drugs approved for the treatment of insomnia, taken nightly over time, may degrade sleep quality and result in alarming side effects, especially in older adults.

That said, while the medication prescribed for IDI is usually a benzodiazepine or a Z-drug such as zolpidem or eszopiclone, a second pharmacological approach, according to a paper by Michael Perlis and Philip Gehrman, involves use of a melatonin agonist such as ramelteon (Rozerem). No studies of the effects of this sleeping pill on the sleep of adults with IdI have been conducted. But in two studies of children aged 6 to 12 years with chronic idiopathic childhood sleep-onset insomnia, melatonin put them to sleep significantly sooner—by 1 hour.

If you’re contemplating managing lifelong insomnia with drugs, get some professional advice. This is one place where you really need the help of a specialist knowledgeable in the medical treatment of chronic insomnia.

At what age did your trouble sleeping start? What kinds of treatments—if any—have helped?

Use OTC Sleep Aids With Caution

The sleeping pill of choice for many Americans with insomnia can be purchased over the counter at drug and grocery stores. But a new study shows that many older adults who use OTC sleep aids know little about them and may be using them in ways that do more harm than good.

Sleeping pill users should read the label of OTC sleep medicationsIt annoys me when people dismiss sleeping pills as categorically harmful. Yes, they can be used inappropriately and it’s important to be informed about their downsides. But the existence of downsides doesn’t necessarily mean the risks associated with using them outweigh the benefits.

The sleeping pill of choice for many Americans with insomnia can be purchased over the counter at drug and grocery stores. But a new study shows that many older adults who use OTC sleep aids know little about them and may be using them in ways that do more harm than good.

Older Americans Use Them and Like Them

Participants in the new study were adults in the United States aged 60 and older who were managing their sleep problems with nonprescription sleep aids. University of Pittsburgh investigators interviewed 116 by telephone and found that well over half were satisfied with their medication and felt it improved their sleep.

Asked about her satisfaction with one such drug, an interviewee replied that she was “pretty satisfied. It does help me fall asleep and stay asleep, and go back to sleep when I invariably get up once or twice a night.”

“There is a dramatic difference when I use it versus when I don’t,” another explained.

This jibes with the results of other, quantitative research. The prevalence of insomnia and other sleep problems among older adults is high and OTC sleep aids are widely available. About 17% of older adults in the United States turn for relief to antihistamine-containing sleep aids like Unisom and Simply Sleep.

How OTC Sleep Aids Work

Diphenhydramine and doxylamine are the active ingredients in antihistamine sleep aids. They block the action of histamine neurons, which are generally active when we’re awake and inactive when we’re asleep.

“Marked drowsiness may occur,” is the type of warning that usually appears on the label. This propensity to cause sedation is likely why, despite few controlled trials supporting their efficacy for insomnia, these drugs are seen as effective by many older adults. The trials that have been conducted suggest these antihistamine sleep aids may have more to offer sleep maintenance insomniacs than people who need help falling asleep at the beginning of the night.

Side Effects of OTC Sleep Aids

But like most prescription medications, OTC sleep aids are not intended for nightly or long-term use. Continuous use has been found to lead to the development of tolerance, tempting users to take more of the drug to get the same sedative effect. Yet in the Pittsburgh study, nearly half of the participants reported using OTC sleep meds daily or very often. Over half reported using them for more than a year.

Fewer than a quarter of the study participants had studied the label on their medication to find out about the recommended dosage or about warnings and possible side effects.

“I never really paid any attention to the directions,” an interviewee said. “I take a couple before I go to bed, about twenty minutes before I go to sleep, I go upstairs and go to bed. That’s it.”

Common side effects to be aware of are morning grogginess (our bodies process drugs more slowly as we age) and blurred vision, constipation, and trouble urinating (for more on this, see my post on OTC sleep aids and anticholinergic effects).

Drug-Drug Interactions

Possible drug-drug interactions is another factor to take into account, given that almost 40% of older Americans are taking five or more prescription medications. Studies have shown that diphenhydramine (the main ingredient in many OTC sleep aids, including Benadryl, Sominex, Nytol, ZzzQuil, and Simply Sleep) interferes with the body’s metabolizing of at least three commonly prescribed drugs:

  1. tamoxifen, an anti-estrogen drug used to treat breast cancer and lower breast cancer risk
  2. metoprolol (Lopressor), a beta blocker used to treat high blood pressure and heart problems
  3. venlafaxine (Effexor), a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) used to treat depression

Reducing the effectiveness of a drug taken to manage a serious health condition isn’t something most of us would want to do. But information about all possible drug-drug interactions isn’t necessarily listed on the label of OTC sleep aids.

Americans seem to have the attitude that OTC meds are harmless—but that isn’t necessarily true. If you’re going to use an OTC sleeping pill, read the label for information about the proper dosage and potential side effects. Take concerns about possible drug-drug interactions to your doctor or pharmacist.

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?