CYCLOBENZAPRINE TAB,SUBLINGUAL
Clinical Criteria Summary
Indication & Patient Population
- Treatment of fibromyalgia in adults
- Adults with a primary diagnosis of fibromyalgia based on 2016 revisions of the 2010/11 Fibromyalgia Diagnostic Criteria
- Patients requiring a 7-day baseline Numeric Rating Scale (NRS) average daily pain intensity score ≥4 and ≤9
Dosing & Administration
- Starting dose: 2.8 mg (1 SL tablet) once daily at bedtime for the first 14 days
- Target dose: 5.6 mg (2 SL tablets) once daily at bedtime starting on Day 15
- Maximum recommended dosage: 5.6 mg once daily
- Geriatric patients: Maximum recommended dosage is 2.8 mg administered SL once daily at bedtime
- Mild hepatic impairment (Child Pugh A): Recommended dosage is 2.8 mg administered SL once daily at bedtime
- Not recommended in moderate or severe hepatic impairment
- Administration protocol: Administer after completion of evening oral care; drink a few sips of water to moisten mouth; place tablet under the tongue and allow to dissolve completely; do not cut, chew, crush, or swallow whole; do not talk for ≥5 minutes after administration; avoid eating or drinking for at least 15 minutes after tablet has completely dissolved; preferably avoid any hot, cold, or acidic beverages until morning
Contraindications & Safety Precautions
- Contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation
- Contraindicated during the acute recovery phase of myocardial infarction (MI)
- Contraindicated in patients with arrhythmias, heart block, conduction disturbances, or congestive heart failure (CHF)
- Contraindicated in hyperthyroidism
- Verify pregnancy status prior to treatment in patients who can become pregnant due to embryofetal toxicity risk (neural tube defects)
- Advise effective contraception during treatment and for 2 weeks after the final dose
- Monitor for serotonin syndrome, TCA-like adverse drug reactions (cardiac reactions, lowered seizure threshold), atropine-like ADRs, oral mucosal ADRs, and CNS depression
Place in Therapy & Formulary Considerations
- Consider when formulary treatments have been trialed without adequate response, with intolerable side effects, or are not clinically appropriate
- Targeted for bedtime use to address non-restorative sleep, pain, fatigue, and sleep impairments
- A trial with cyclobenzaprine IR at bedtime may be considered prior to evaluating non-formulary options
- Insufficient evidence to broadly support as a first-line therapy over other approved or off-label agents