Patient counseling information for BELSOMRA® (suvorexant) C-IV, 5, 10, 15, 20 mg tablets
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
CNS depressant effects and next-day impairment
Tell patients that BELSOMRA has the potential to cause next-day impairment, and that this risk is increased with higher doses or if dosing instructions are not carefully followed. Patients using the 20 mg dose should be cautioned against next-day driving and other activities requiring full mental alertness as this dose is associated with a higher risk of impaired driving. Patients taking lower doses should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA.
Patients should not drive or engage in other activities requiring full alertness within 8 hours of dosing of BELSOMRA. Advise patients that increased drowsiness may increase the risk of falls in some patients.
Sleep-driving and other complex behaviors
Instruct patients to inform their families that BELSOMRA has been associated with getting out of bed while not being fully awake, and tell patients and their families to call their health care providers if this occurs.
Hypnotics, like BELSOMRA, have been associated with “sleep-driving” and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients and their families to call their health care providers if they develop any of these symptoms.
Suicide
Tell patients to report any worsening of depression or suicidal thoughts immediately.
Alcohol and other drugs
Ask patients about alcohol consumption, prescription medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use BELSOMRA if they drank alcohol that evening or before bed.
Tolerance, abuse, and dependence
Tell patients not to increase the dose of BELSOMRA on their own, and to inform you if they believe the drug “does not work.”
Administration instructions
Advise patients to take BELSOMRA only when preparing for or getting into bed and only if they can stay in bed for a full night before being active again. Advise patients to report all of their prescription and nonprescription medicines, vitamins, and herbal supplements to the prescriber.
Before prescribing BELSOMRA, please read the Prescribing Information. The Medication Guide also is available.
References
1. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-IMA-01371.
2. Walsh JK, Roth T. Pharmacologic treatment of insomnia: benzodiazepine receptor agonists. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. Fifth edition. St. Louis, MO: Elsevier Saunders; 2011:905–915.
3. Herring WJ, Connor KM, Ivgy-May N, et al. Suvorexant in patients with insomnia: results from two 3-month randomized controlled clinical trials. Biol Psychiatry. 2016;79(2):136–148.
4. Your guide to healthy sleep. National Heart, Lung, and Blood Institute. NIH Publication No. 11-5271. Revised August 2011.