

A New FDA Approval Brings New Psychiatric Risks
Sep 1, 2025
The FDA has approved cyclobenzaprine for treating fibromyalgia, but it comes with significant psychiatric risks, especially for the elderly. The conversation highlights the dangers of combining opioids, muscle relaxants, and benzodiazepines, which can lead to overdose. There's a focus on the 'Holy Trinity' of medications and the legal ramifications for prescribers. Additionally, potential adverse effects, like mania in bipolar patients, are discussed, stressing the importance of evidence-based interventions before medication.
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Avoid Dangerous Sedative Combinations
- Avoid co-prescribing cyclobenzaprine with benzodiazepines or opioids because combinations raise overdose death risk.
- Heed pharmacists and regulators who may flag these combinations to protect patients and your license.
A Long-Used Drug Gets FDA Approval
- Cyclobenzaprine is newly FDA-approved for fibromyalgia but has decades-long off-label use as Flexeril.
- It was historically the most commonly prescribed fibromyalgia med despite lacking that formal indication until 2025.
Check Med Lists Before Prescribing Sedatives
- Check medication lists for tramadol, muscle relaxants, and benzodiazepines before adding another sedative.
- If pharmacists question your clonazepam or sedative scripts, respond respectfully and review the combo for safety.