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

BELSOMRA is available in multiple doses.
Eligible practitioners may request available samples of BELSOMRA for your appropriate patients.
Eligible, privately insured patients may save on BELSOMRA.
Eligible patients may receive a free 10-tablet trial supply of BELSOMRA.
11. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package NEUR-1129594-0000.
Selected Safety Information for BELSOMRA® (suvorexant)
  • BELSOMRA is contraindicated in patients with narcolepsy.
  • BELSOMRA contains suvorexant, a Schedule IV controlled substance.
  • 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).
  • 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%).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 accompanying Prescribing Information. The Medication Guide also is available.

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Selected Safety Information for BELSOMRA® (suvorexant)
  • BELSOMRA is contraindicated in patients with narcolepsy.
  • BELSOMRA contains suvorexant, a Schedule IV controlled substance.
  • 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).
  • 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%).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 accompanying Prescribing Information. The Medication Guide also is available.