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NEW ORLEANS -- The antidepressant trazodone is no stranger to off-label use, especially for insomnia, a real-world study found.

Among 1.4 million patients identified from U.S. medical and pharmacy claims data, over 100,000 were prescribed trazodone. Of these, 61% were diagnosed with depression within the previous 12 months, 39% were diagnosed with insomnia within the previous 6 months, and 22% were diagnosed with both, reported William V. McCall, MD, of the Medical College of Georgia in Augusta.

"Trazodone is a frequently prescribed medication," McCall explained during a poster presentation at Psych Congress 2022. "About 10% of people in outpatient care are receiving it at some time or another over the course of a year follow-up and they do not always necessarily have a diagnosis of insomnia, even though the dosing that has been given is highly suggestive that insomnia in fact is what the trazodone is being prescribed for."

Currently, trazodone is only FDA-approved for major depressive disorder at a dose of 150-400 mg per day.

Of note, McCall's group found that 44,402 patients given trazodone weren't diagnosed with depression or insomnia, but instead were diagnosed with one of a wide range of conditions, including anxiety, fibromyalgia, diabetic neuropathy, and sexual dysfunction.

"One of the things we've learned from this poster is that often times trazodone is prescribed without a clear indication in the chart of an ICD code and diagnosis that goes along with the trazodone prescription," said McCall.

"Regardless of whether or not there was a diagnosis for insomnia or whether or not there was a diagnosis of depression, the doses of trazodone prescribed in about two-thirds of instances were 150 mg or less," he added:

• With insomnia/without depression: 67% dosed under 150 mg vs 33% dosed 150+ mg
• Without insomnia/with depression: 58% vs 42%, respectively
• Both insomnia and depression: 60% vs 40%
• Neither insomnia nor depression: 63% vs 37%

Looking at patients with insomnia, with or without depression, the most prescribed dose was 100 to 149 mg/day (40.7%). That being said, this was also the most prescribed dose for patients without insomnia, with or without depression, as well (39.8%).

"This tells us that the drug has been used at doses well below what has been typically recommended by the FDA for the treatment of depression; hence, we can infer that in most instances, trazodone in fact is being prescribed for something other than depression -- probably insomnia -- whether or not there's actually an insomnia diagnosis or not," McCall suggested.

"The relevance of these findings is that trazodone is not FDA-approved for insomnia -- of course physicians have the latitude of prescribing beyond the FDA indication," he noted, but there "is not much data to support the efficacy or safety of trazodone as a surrogate hypnotic medication."

"We have a feeling trazodone is not necessarily the most effective of hypnotic choices," he added, explaining that it's typically a weaker hypnotic than other FDA-approved agents for insomnia and can often come with a slew of side effects, like memory problems and fatigue.

Data for this study were collected from 2015 to 2020 from claims appearing in HealthVerity for adult patients. Those who were pregnant, undergoing palliative care, or had active malignancies, anxiety, ADHD, migraine, or nervousness were excluded. Diagnoses for insomnia were identified via ICD codes.

Of the 112,995 patients prescribed trazodone, mean age was 49, and 66% were women.

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