BELSOMRA®

(suvorexant) tablets, for oral use, C-IV

Dosing

Important things to discuss with patients starting BELSOMRA

Recommend an adequate trial period

  • The way your patients feel when they fall asleep may be different from their previous experience or expectations1
  • It may take a few nights to a week for your patients to assess the effect of BELSOMRA2,3
  • In two 3-month clinical trials with BELSOMRA 15 mg and 20 mg, patients reported less total sleep time during Week 1 than was measured by polysomnography (PSG); however, over time, patient-reported total sleep time approached what was measured by PSG1
  • Reevaluate for comorbid conditions if insomnia persists after 7 to 10 days of treatment

Counsel your patients

Consider potential effects if discontinuing other insomnia therapies (eg, rebound insomnia, withdrawal).4

Continue to encourage good sleep hygiene habits

Good Sleep Hygiene Habits Include Turning Off Electronics an Hour Before Going to Bed

Turn off electronics an hour before going to bed5

Good Sleep Hygiene Habits Include Going to Bed and Getting Up at the Same Time Each Day

Set a schedule: Go to bed and get up at the same time each day5,6

Good Sleep Hygiene Habits Include Avoiding Alcohol Before Going to Bed

Avoid alcohol before going to bed6

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).

Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment and with each prescription refill. Review the BELSOMRA Medication Guide with every patient prior to initiation of treatment.

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.

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 NEUR-1129595-0000.

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. Neubauer DN. The evolution and development of insomnia pharmacotherapies. J Clin Sleep Med. 2007;3(5 suppl):S11–S15.

5. National Sleep Foundation. Tips for falling asleep. https://sleepfoundation.org/insomnia/sleep-news/what-do-when-you-cant-sleep. Accessed March 29, 2018.

6. National Institute of Neurological Disorders and Stroke (NINDS). Brain Basics: Understanding Sleep. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Understanding-Sleep#8. Accessed March 29, 2018.

Indication

BELSOMRA is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Selected Safety Information

Contraindications

  • BELSOMRA is contraindicated in patients with narcolepsy.
  • BELSOMRA contains suvorexant, a Schedule IV controlled substance.

Warnings and Precautions

  • BELSOMRA is a central nervous system (CNS) depressant and can impair daytime wakefulness even when used as prescribed. Prescribers should monitor for somnolence and CNS depressant effects, but impairment can occur in the absence of symptoms, and may not be reliably detected by ordinary clinical exam. CNS depressant effects may persist in some patients for up to several days after discontinuing BELSOMRA.
  • BELSOMRA can impair driving skills and may increase the risk of falling asleep while driving. Discontinue or decrease the dose in patients who drive if daytime somnolence develops. Caution patients taking BELSOMRA 20 mg against next-day driving and other activities requiring full mental alertness. Caution patients taking lower doses of BELSOMRA as well, because there is individual variation in sensitivity to BELSOMRA.
  • Coadministration with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Patients should be advised not to consume alcohol in combination with BELSOMRA due to additive effects. Dosage adjustments of BELSOMRA and of other concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of BELSOMRA with other drugs to treat insomnia is not recommended.
  • The risk of next-day impairment, including impaired driving, is increased if BELSOMRA is taken with less than a full night of sleep remaining, if a higher than recommended dose is taken, if coadministered with other CNS depressants, or if coadministered with other drugs that increase blood levels of BELSOMRA. Patients should be cautioned against driving and other activities requiring complete mental alertness if taken in these circumstances.
  • Symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. Reevaluate for comorbid conditions if insomnia persists after 7 to 10 days of treatment.
  • A variety of cognitive and behavioral changes (eg, amnesia, anxiety, hallucinations, and other neuropsychiatric symptoms) have been reported with the use of hypnotics such as BELSOMRA. Complex behaviors such as “sleep-driving” (ie, driving while not fully awake after taking a hypnotic) and other complex behaviors (eg, preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with the use of hypnotics. Discontinuation of BELSOMRA should be strongly considered for these patients. The use of alcohol and other CNS depressants may increase the risk of such behaviors. These events can occur in hypnotic-naïve as well as hypnotic-experienced persons. Discontinuation of BELSOMRA should be strongly considered for patients who report any complex sleep behavior.
  • In clinical studies, a dose-dependent increase in suicidal ideation was observed in patients taking BELSOMRA, as assessed by questionnaire. Immediately evaluate patients with suicidal ideation or any new onset behavioral changes. In primarily depressed patients treated with sedative-hypnotics, worsening of depression or suicidal thinking, including suicidal thoughts and actions (including completed suicide), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
  • The effect of BELSOMRA on respiratory function should be considered if prescribed to patients with compromised respiratory function.
  • Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid perceptions by the patient, can occur with use of BELSOMRA.
  • Symptoms similar to mild cataplexy can occur, with risk increasing with the dose of BELSOMRA. Such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur both at night and during the day, and may not be associated with an identified triggering event (eg, laughter or surprise).

Adverse Reactions

  • In clinical studies, the most common adverse reaction (reported in 5% or more of patients treated with 15 mg or 20 mg of BELSOMRA and at least twice the placebo rate) was somnolence (BELSOMRA 7%, placebo 3%).

Additional Safety Information

  • In clinical studies, during the first 3 months of treatment, the adverse reactions reported in ≥2% of patients treated with 15 mg or 20 mg of BELSOMRA and more commonly than in patients treated with placebo, were, diarrhea (BELSOMRA 2%, placebo 1%), dry mouth (2%, 1%), upper respiratory tract infection (2%, 1%), headache (7%, 6%), somnolence (7%, 3%), dizziness (3%, 2%), abnormal dreams (2%, 1%), and cough (2%, 1%).
  • At doses of 15 mg or 20 mg, the incidence of somnolence was higher in females (8%) than in males (3%). The incidence of headache, abnormal dreams, dry mouth, cough, and upper respiratory tract infection occurrence in women was at least twice that in men.

Drug Interactions

  • When BELSOMRA was coadministered with alcohol, additive psychomotor impairment was demonstrated.
  • Concomitant use of BELSOMRA with strong inhibitors of CYP3A (eg, ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) is not recommended.
  • The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (eg, amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). The dose can be increased to 10 mg in these patients if necessary for efficacy.
  • The efficacy of BELSOMRA may be reduced when coadministered with strong CYP3A inducers (eg, rifampin, carbamazepine, phenytoin).
  • Slightly increased levels of digoxin were seen with coadministration of BELSOMRA. Digoxin levels should be monitored when coadministering BELSOMRA with digoxin.

Use in Specific Populations

  • No clinical studies have been conducted in pregnant women. BELSOMRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • It is not known if BELSOMRA is secreted in human milk. Use caution when administering to nursing women.
  • Safety and effectiveness of BELSOMRA in pediatric patients have not been established.

Drug Abuse and Dependence

  • BELSOMRA contains suvorexant, a Schedule IV controlled substance.
  • Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to BELSOMRA, health care providers should follow such patients carefully when those patients are receiving BELSOMRA.

Dosage and Administration

  • 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 effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg once daily.
  • Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose.
  • When BELSOMRA is combined with other CNS depressant drugs, dosage adjustment of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects. The recommended dose of BELSOMRA is 5 mg when used with moderate CYP3A inhibitors, and the dose generally should not exceed 10 mg in these patients.
  • BELSOMRA is not recommended for use with strong CYP3A inhibitors.
  • The effect of BELSOMRA may be delayed if taken with or soon after a meal.
  • No dose adjustment is required in patients with mild and moderate hepatic impairment. BELSOMRA has not been studied in patients with severe hepatic impairment and is not recommended for these patients.

Before prescribing BELSOMRA, please read the Prescribing Information. The Medication Guide also is available.

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