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Ask the Expert: Is there evidence to prescribe cyclobenzaprine for long-term pain management?

Long-term use of cyclobenzaprine requires further study to confirm its efficacy.
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At 12 months, a similar number of patients reported at least one new adverse event among both groups. However, 18 of the 79 (23%) versus 9 of the 79 (11%) withdrew in the placebo-cyclobenzaprine and cyclobenzaprine-cyclobenzaprine groups, respectively. There was no difference in secondary outcomes except in responder analysis (PGIC). The mean change from baseline in NRS assessments of average pain based on 24-hour recall are described in Table I.

More patients from the cyclobenzaprine-cyclobenzaprine treatment group in both studies reported a PGIC score of either 1 or 2 (40.5% vs. 21.5%) at 12 months. Serious adverse events were reported by 6% of the cyclobenzaprine-cyclobenzaprine group versus 4% of the placebo-cyclobenzaprine group. The most common adverse event from the cyclobenzaprine-cyclobenzaprine group was sinusitis (12.7% vs. 1.3%), and from the placebo-cyclobenzaprine group oral hypoesthesia (27.9% vs. 1.3%).10 No statistical analyses were provided for any outcomes. Based on these results, no efficacy was noted for long-term use, while side effects were frequently reported.10

Lastly, a multicenter, randomized, double-blind study evaluated the efficacy and safety of sublingual, very low dose cyclobenzaprine (5.6 mg) versus placebo in patients with military-related PTSD.11 The primary outcome was mean change of a clinician-administered PTSD scale. Secondary outcome measures were assessment of disruptions of social life/leisure activates, school/work activities, and quality of sleep using the Sheehan Disability Scale. All measures were assessed at 12 weeks. Patients meeting inclusion criteria were those with a diagnosis of PTSD consistent with the Diagnostic Symptoms Manual (DSM-5) criteria.12 The study is currently recruiting patients with an anticipated competition of October 2018.11

Efficacy Remains Uncertain

Although cyclobenzaprine is commonly used in the acute setting of musculoskeletal conditions, a new formulation—a very low dose sublingual formulation—is under consideration for long-term use in symptom control of fibromyalgia and is being studied for PTSD. Adverse effects of long-term use are similar to short-term use of oral cyclobenzaprine. Studies for sublingual use shows it may also be associated with hypoaesthesia, which was more predominant during the first 12 weeks of use but can limit its use.

Long-term use of sublingual very low dose cyclobenzaprine (12 months) shows it does not maintain effectiveness in treating symptoms of fibromyalgia. Ongoing research for use of sublingual, very low dose cyclobenzaprine for symptoms of PTSD is currently under investigation.

Last updated on: March 4, 2018
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