HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BELSOMRA safely and effectively. See full prescribing information for BELSOMRA.
BELSOMRA ® (suvorexant) tablets, for oral use, C-IV
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (1).
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient (2.1).
Recommended dose is 10 mg, no more than once per night taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily (2.1, 2.2).
Time to effect may be delayed if taken with or soon after a meal (2.5).
DOSAGE FORMS AND STRENGTHS
Tablets, 5mg, 10mg, 15mg, 20mg (3).
CONTRAINDICATIONS
Do not use in patients with narcolepsy (4).
WARNINGS AND PRECAUTIONS
Daytime somnolence: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness (5.1).
Need to eva luate for co-morbid diagnoses: Reeva luate if insomnia persists after 7 to 10 days of treatment (5.2).
Nighttime "sleep-driving" and other complex behaviors while out of bed and not fully awake. Risk increases with dose, with use of CNS depressants, and with alcohol (5.3).
Depression: Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately eva luate any new behavioral changes (5.4).
Compromised respiratory function: Effect on respiratory function should be considered (5.5, 8.6).
Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms: Risk increases with dose (5.6).
ADVERSE REACTIONS
The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once daily if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors (2.4, 7.2).
Strong CYP3A inducers: Efficacy may be reduced (7.2).
Digoxin: Monitor digoxin concentrations (7.3).
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1).
Patients with severe hepatic impairment: Not recommended (8.7).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2014
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
Use the lowest dose effective for the patient.
The recommended dose for BELSOMRA is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not |
