Elder Drugs » Conditions

Restless Leg Syndrome: Comparative Effectiveness Review by AHRQ

Alan Lukazewski — Sun, 06 May 2012 13:34:02 +0000

Restless leg syndrome (RLS) is a condition that can negatively impact quality of life leading to daytime sleepiness and fatigue, interferes with work and social activities, and may lead to anxiety and depression. Treatments vary from exercise, herbal remedies, iron replenishment, and prescription medication options the most frequently chosen option. Although pharmacologic therapies offer relief in many individuals that are superior to other options, withdrawl from these medications is common due to adverse effects and/or augmentation (defined as a worsening of symptoms due to the drug therapy). The Agency for Health Care Research and Quality (AHRQ) has a comparative effectiveness review at the following link. http://www.effectivehealthcare.ahrq.gov/ehc/products/334/1055/RLS_Draft-Report_20120501.pdf

Here is a summary of the report findings:

Many studies used highly selected populations with high-severity of symptoms thereby there is lacking good evidence in those with mild to moderate symptoms.
“As needed” drug therapies were not evaluated yet there is suggestion that “as needed” use may be beneficial and warrants further study.
Secondary causes of RLS, such as iron deficiency, when corrected lead to symptom reduction.
Non-drug treatments, such as exercise and compression stockings, are effective yet adherence to these methods is poor.
Dopamine agonists, such as Requip (ropinorole) and Mirapex (pramapexole), are effective at reducing symptoms but in many studies there was also a high placebo effect.
Drop out rates from studies were high due to 1) augmentation (worsening of the disease symptoms from drug therapy) 7-62%, 2) adverse effects such as nausea, vomiting, somnolence, fatigue and 3) lack of effectiveness 6-32%.
Benefits from medication therapies tended to not be sustained over time.
GABA analogues, e.g. Neurontin (gabapentin) and Lyrica (pregabalin) showed no good evidence for efficacy.

One other consideration is to watch out for the adverse effects of orthostatic hypotension (dizziness upon standing) obsessive compulsive behaviors, gambling addictions, inappropriate sexual behaviors, and “sleep attacks” as uncommon but potentially life-altering adverse effects from dopamine therapies.

Tips:

Maximize trials of non-drug options, such as stretching every day and before bedtime, improving sleep hygiene, and avoiding caffeine, nicotine, sedative hypnotics and antihistamines, all known to worsen RLS.
If symptoms worsen after initiating drug therapies, consider that augmentation may be occurring and dose reduction may be appropriate, along with non-drug interventions.
If any of the above symptoms appear after initiation of drug therapy, assume a drug is responsible.

FDA Approves First Sleep Agent for Early Awakening: Intermezzo

Alan Lukazewski — Sun, 27 Nov 2011 23:19:09 +0000

FDA just approved a new drug for early awakenings, called Intermezzo, a low-dose form of zolpidem, the active ingredient in Ambien and Ambien CR. In addition to the lower doses, each different for men and women, it is a sublingual tablet, or to be used under the tongue. The drug is intended to be used in the middle of the night, with at least 4 hours of sleep remaining, in those who have difficulty in getting back to sleep after an early awakening. The drug is NOT intended for routine use, as is any other hypnotic. Routine use of hypnotics is associated with daytime drowsiness, increased risk for falls, cognitive impairment and forms of amnesia.

The dose for men is 3.5mg and the dose for women is 1.75mg, lower because women apparently metabolize zolpidem slower than men. Using a higher dose than 1.75mg in women may make the drug unsafe. Commonly reported side-effects are: headache, nausea and fatigue.

As stated above, routine use of hypnotics is not recommended in older adults. for more information on how you can improve your sleep, go to the AgePages brochure at: http://www.nia.nih.gov/NR/rdonlyres/98A1060C-2151-4F9A-A558-964E3D2D4EFA/17898/GoodNightsSleep.pdf

Minimizing Drug Misuse Among Elders: a Proposal

Alan Lukazewski — Wed, 23 Nov 2011 04:32:04 +0000

“Something old, something new” is what I thought of when I read this article from 1987, that proposed tracking OTC use among elders in the community in order to study OTC misuse leading to adverse drug events. This is not a new concept, that OTCs can cause harm and should be considered a vital part of the medication review. However, many pharmacies do not, and cannot track OTC use, nor do medication interviews always pick up on OTC use. However, we do know that OTC NSAID use is a large contributor to gastrointestinal bleeding among older adults, and they can be used in those taking other drugs that can put an older adult at risk for hemorrhaging. We can also see hypertension caused by NSAIDs along with renal damage from chronic use. So finding out about OTC use is important.

What we have found in some of our falls prevention workshops, when performing medication reviews, is that older adults tend to not report these OTCs as part of their drug regimen thinking they are safe or not of any consequence. We have learned to probe by asking the specific questions: “Do you use an OTC pain medication like Motrin, (iburpofen), Aleve (naproxen), etc. for pain?” We also ask about OTC medications like Tylenol PM for sleep. OTC sleep medications contain antihistamines that are known to cause memory health issues and also contribute to falls.

So I ask myself, when looking at all the studies on adverse drug events in older adults going back 20 or more years, which cover many of the same topics, and uncover many of the same findings as studies published more recently, is this something old, or something new?

When having your medications reviewed, or if you review medications of others as a practitioner, include all the OTCs and herbal supplements, or where non-drug interventions are beneficial. Here’s the link to the article authored by Jean Craig and Gayle eves:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477723/pdf/pubhealthrep00179-0088.pdf

I Can Go to Sleep Now, Right?

Alan Lukazewski — Sun, 27 Mar 2011 14:09:39 +0000

A recent article in the New York Times summarized findings from a study done by the University of Pittsburgh in which they improved sleep in two-thirds of participants as compared to 25% in the control group. What’s valuable is that they did it without medications. It is well known that medications for sleep, such as Ambien (zolpidem), Restoril (temazepam), Lunesta (eszopiclone), Sonata (zaleplon), among others, are less effective at managing chronic insomnia than non-drug therapies. These medications are also known to cause cognitive impairment, depression and contribute to the risk of falls. So why do we rely upon medications for insomnia? It may be explained simply by the fact that taking a medication is easier than changing our behaviors. However, in this study the research team counseled the participants for only two brief sessions, 45-60 minutes for the first session and the second session about 30 minutes. They then performed two brief follow up calls to the participants. In the treatment group, 55% no longer had insomnia and after 6 months and three-quarters of those tested had maintained or improved their better sleep patterns.

The research team focused on simple interventions thereby making the behavior changes more likely to be embraced by the participants. The key concept was to stick to a schedule that maximizes “sleep efficiency”. The four rules they applied were: Reduce the time spent in bed. Get up at the same time every day. Don’t go to bed until you feel sleepy. Don’t stay in bed if you’re not sleeping. The treatment group received explanations about how the behavior changes work and that for the first few weeks they may feel more tired and sleep-deprived, but that the payback comes later. Perhaps that simple explanation, in which the person knows what to expect, helps them adhere to the suggested behavior changes, versus the control group that just received brochures on insomnia. The researchers cited that just reading about insomnia and the behavior changes didn’t lead to positive results.

Here’s the NY Times link: http://newoldage.blogs.nytimes.com/2011/03/23/simple-rules-for-better-sleep/?emc=eta1