Silenor (doxepin) is a tricyclic antidepressant promoted for difficulty maintaining sleep, not for ensuring Stage IV depth of sleep.20 It had no effect on Stage IV sleep, and its use was discontinued in 10% of patients entered into a study of its use for primary insomnia because of increased liver enzymes, leukopenia and thrombocytopenia.20,47 It is contraindicated in the presence of sleep apnea, depression, diabetes and those receiving the ever-present (at least in patients afflicted with musculoskeletal disorders or GERD) gastroprotective agents.
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Trazodone shares those caveats and is additionally contraindicated in individuals with heart disease or seizure disorders. Indeed, trazodone was found not to exceed placebo effect on sleep.38 It is actually indicated for depression, not as a sleep aid—despite its wide prescription for the latter.48 Sedation, dizziness and psychomotor impairments are major high-frequency side effects.49 Trazadone does not augment Stage IV or REM sleep.50 Mendelson noted the dearth of efficacy data, suggesting an unacceptable risk–benefit ratio with its use.49
Rozeron (ramelteon) has “no clinically meaningful effect on sleep architecture” or any subjective sleep measure.51,52 It actually decreases the percentage of time in Stage IV sleep.53
If we ignore the depressive effect of chronic pain, it still should be noted that depression is a contraindication to the medications promoted by insurance companies. Not only are the promoted drugs dangerous by themselves, but they complicate patient care and place patients at greater and unnecessary risk.
To Think About …
Should insurance company “protocols” not be held to the same standards as the peer-reviewed literature? What are the qualifications of those doctors and pharmacists who insurance companies allege as having established these protocols, the “lists of acceptable medications,” and why do insurance companies appear so reticent to identify these “experts”? It seems obvious that there needs to at least be a dialogue, but how does one effectively communicate with insurance companies that don’t even have the courtesy to respond?
Bruce Rothschild, MD, is professor of medicine at Northeast Ohio Medical University and provides rheumatology services at the Indiana Regional Medical Center. He is a Fellow of the American College of Physicians, the ACR and the Society of Skeletal Radiology and was elected to the International Skeletal Society. He has been recognized for his research in musculoskeletal disease, but fundamentally remains a clinical rheumatologist seeking to remove impediments to the provision of quality care to the patients we serve.
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