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Rx for A Good Nights Sleep

November 8, 2005

Rx for A Good Night's Sleep

Prescription sleep-drugs are often regarded with suspicion: Are they safe? Are they addictive? What are the side effects? Such concerns may be causing elderly Americans to seek alternative, non-prescription solutions for insomnia or poor sleeping patterns.

Such homespun remedies as soothing music and alcohol are common forms of self-medication, according to survey conducted for the International Longevity Center -USA (published in October 2005) and reported by MedPage Today on 3 November 2005. Melatonin and antihistamines - both available without a prescription -are also popular.

One relatively new prescription sleep-aid may offer a compromise for people with sleep problems who have concerns about prescription sleeping pills. Rozerem (ramelteon) received FDA approval in July 2005 as the first melatonin receptor agonist for treating insomnia. In contrast to most prescription sleep-drugs, Rozerem is not categorized as a controlled substance.

The Gallup Study

One in four Americans reported having a sleep-problem, according to the national Gallup telephone survey of 1,003 adults aged 50 years and older. Eight out of ten participants (80%) believed that getting enough sleep "significantly impacts health," according to the survey.

When participants were asked to rate the safety of prescription sleep medications (using a 5-point scale), 36% said they were "not safe"(rating them 1 or 2), 31% gave a middle rating of 3 and 10% were unsure, according to the survey.

Only 23% of respondents believed that prescription sleep medications were "very safe".

The average rating for the safety of prescription sleep-aids was 2.7.

Of participants who reported having a sleep problem, 72% said they consulted with a healthcare provider, but only 47% of these reported receiving treatment for their problem.

The survey also revealed these statistics:

Importance of Good Sleep
Respondents ranked "good sleep quality" fourth of five healthy lifestyle factors (below "good nutrition," "mental sharpness" and "regular exercise"and above "interpersonal relationships")

Who Has Trouble Sleeping
Only 32% of older adults report getting a good night's sleep seven nights of the week.
Less than half of older adults get >7 hours' sleep each night, and about 20% get <6 hours sleep.
Older men are more likely than older women (38% vs. 27%) to report getting a good night's sleep seven nights per week.
46% of adults who say their health is "excellent" are the most likely to report getting a good night's sleep every night.

Factors that Interfere with Good Sleep
Older adults display a variety of sleep behaviors that can interfere with their ability to fall or stay sleep, including:
Getting up to use the bathroom in the middle of the night (43%)
Falling asleep watching a TV show or movie (22%)
>25% of older adults report that worry of some kind has interfered with being able to fall or stay asleep.
37% of adults aged =50 years report that, in the past month, worry has interfered with their ability to fall asleep, and 26% report that worry has interfered with their ability to stay asleep.

Caregivers- A Special Case
12% of older adults are the primary caregiver for a chronically ill relative or friend.
Older people who are primary caregivers of chronically ill people are more likely to get <7 seven hours' sleep at night.
50% of primary caregivers say that worry has interfered with their ability to fall asleep, and 36% report that worry has interfered with their ability to stay asleep.
Nearly 28% of caregivers report that their caregiver role interferes with their sleep at least sometimes (12% say it happens frequently; 16% say it happens sometimes).

Health Conditions That Interfere with Sleep
Heart disease (16%)
Cancer (14%)
Weight problems (13%)
Hypertension (11%)

Who Seeks Help for Sleep Problems?
72% of older adults who have identified they have a sleep problem report speaking to their healthcare provider about it.
Of these individuals, 47% report they are being treated for a sleep disorder.

Concerns about Prescription Sleep Drugs
25% of older adults who feel they have a sleep problem report taking a prescription sleep medication.
The most frequently cited safety concerns about prescription sleep medications include:
Long-term effects (73%)
Addiction (68%)
Feeling groggy and not well rested during the day (67%)

Excluding prescription sleep drugs, respondents reported using these sleep-aids in the past month:
Audio tapes (12%)
Over-the-counter (OTC) medications (11%)
OTC antihistamines or cold medicines (8%)
Herbal remedies (6%)
Prescription medication not prescribed for sleep problems (6%)
Alcohol (5%)

Alternative Sleep-Aids: Men vs. Women
Women are more likely than men to report using OTC sleep medications (13% vs. 8%).
7% of men report using alcohol to help them sleep, compared with 3% of women.

Statistics are from Sleep and Healthy Aging: An Executive Summary of the Gallup Survey.

Sleeping Pills and Safety

Concern about the safety of sleeping pills originated with barbiturates used in the 1960s, which were "remarkably unsafe" and addictive, said Edward Stepanski, PhD, director of a sleep disorders research center at the Rush University Medical Center in Chicago and board member of the American Academy of Sleep Medicine, according to MedPage Today.

Back in the early 1980s, Halcion (triazolam) made headlines with negative reports about addiction and amnesia that have negatively affected public opinion about sleeping pills.

In contrast, the newest non-benzodiazepines are shorter-acting and have not been associated with the unwanted side effect of residual sedation, according to Dr Stepanski. Moreover, these recent sleep-aids appear not to be physically addictive, although psychological addiction may remain a concern for many.

Cognitive behavioral therapy can be an effective alternative to treating sleep problems with drugs, Dr Stepanksi said, according to MedPage Today.

Rozerem -A Better Sleep-Aid?

Older people and others with sleep problems who have concerns about the safety of prescription sleep-medications may find Rozerem (ramelteon) an acceptable alternative, because it is not a controlled substance.

In July 2005, the FDA approved Rozerem, the first melatonin-receptor agonist, for treatment of insomnia. Evidence suggests melatonin is involved in maintaining the circadian rhythm that underlies the normal sleep-wake cycle.

Rozerem differs from standard sleep medications by not being designated as a controlled substance, according to a report in MedPage Today on 25 July 2005.

No evidence arose of dependence or abuse of Rozerem during clinical trails.

"It really is the first of prescription (sleep-aid) drugs in recent times to not be scheduled," said Robert Meyer, MD, director of the pertinent office of drug evaluation at the FDA, according to MedPage Today. "I suspect that will be something that will differentiate it from the others."

Rozerem works by targeting two receptors (MT1 or MT2) in the brain's suprachiasmatic nucleus, which controls circadian rhythms. The activity of Rozerem at the MT1 and MT2 receptor level is believed to underly its sleep-enhancing properties.

"All of [Rozerem's] mechanism is not fully known at this point," Dr Meyer said. "But we know it works. And it does not have a limitation in its labeling for its duration of use."

In contrast, Dr Meyer noted, many over-the-counter sleep-aids are intended for only 7-10 days' use, because of their abuse or dependency potential.

Clinical trials of over 4,200 patients (aged 18-93 years) showed Rozerem was generally well tolerated. Somnolence, fatigue, and dizziness were the most commonly reported side effects.

Because Rozerem is metabolized by the liver, the manufacturer has cautioned that Rozerem should not be used by people with severe hepatic impairment. Also, people taking Luvox (fluvoxamine) should not take Rozerem, and patients with depression should be closely monitored on Rozerem because of its potential to exacerbate symptoms.

"We saw in the clinical trials that Rozerem could increase depression in people who are depressed," Dr Meyer reported to MedPage Today. "We did not see any clear signals of suicide ideation."

The manufacturer warned that suicidal thoughts have been reported with the use of hypnotics.

Rozerem has not been studied in people with sleep apnea, or on people with severe chronic obstructive pulmonary disease, and Rozerem has not been tested in children or adolescents, according to MedPage Today.

Sources:
Sleep and Healthy Aging Survey, conducted by The Gallup Organization for the International Longevity Center (USA), published October 2005.
Older Adults Worry About Safety of Prescription Sleep Drugs, MedPage Today, 3 November 2005.
FDA Approves Rozerem for Insomnia, MedPage Today, 25 July 2005.

Posted: November 2005


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