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Belsomra Generic Name & Formulations
Legal Class
CIV
General Description
Suvorexant 5mg, 10mg, 15mg, 20mg; tabs.
Pharmacological Class
Orexin receptor antagonist.
How Supplied
Blisters—30
Manufacturer
Generic Availability
NO
Belsomra Indications
Indications
Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Belsomra Dosage and Administration
Adult
Use lowest effective dose. Take within 30mins of bedtime if able to get full night’s sleep (≥7hrs) before awakening. 10mg once per night; may increase if ineffective; max 20mg once daily. Concomitant moderate CYP3A inhibitors: 5mg once daily; max 10mg once daily. Effect may be delayed if taken with or soon after a meal.
Children
Not established.
Belsomra Contraindications
Contraindications
Narcolepsy.
Belsomra Boxed Warnings
Not Applicable
Belsomra Warnings/Precautions
Warnings/Precautions
Monitor for CNS depression, somnolence; discontinue or reduce dose if daytime somnolence develops. Risk of next-day impairment (including impaired driving). Discontinue immediately if complex sleep behaviors develop. Depression. Monitor for suicidal ideation. Compromised respiratory function (eg, COPD, obstructive sleep apnea). Increased risk of exposure-related effects in obese women. Monitor for worsening insomnia or abnormal thinking and behavioral changes. Reevaluate if unresponsive after 7–10 days of treatment. Severe hepatic impairment: not recommended. Drug or alcohol abusers. Elderly. Pregnancy. Nursing mothers.
Belsomra Pharmacokinetics
See Literature
Belsomra Interactions
Interactions
Avoid alcohol. Potentiates CNS depression with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol); may need to adjust doses. Concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan): not recommended. Concomitant moderate CYP3A inhibitors (eg, amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil): reduce dose (see Adults). May be antagonized by strong CYP3A inducers (eg, rifampin, carbamazepine, phenytoin). Monitor digoxin.
Belsomra Adverse Reactions
Adverse Reactions
Somnolence, headache, dizziness; complex sleep behaviors (eg, sleep-driving), sleep paralysis, hallucinations, cataplexy-like symptoms.
Belsomra Clinical Trials
See Literature
Belsomra Note
Not Applicable
Belsomra Patient Counseling
See Literature
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