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Name: Suvorexant

Generic Name: Belsomra

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Description

BELSOMRA tablets contain suvorexant, an orexin receptor antagonist.
Suvorexant is described chemically as:
[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl]methanone. Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92.
Suvorexant is a white to off-white powder that is insoluble in water. Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone).

1INDICATIONS AND USAGE

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

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DOSAGE AND ADMINISTRATION

Dosing Information

Use the lowest dose effective for the patient. For all BELSOMRA doses, take no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to effect of BELSOMRA may be delayed if taken with or soon after a meal. The recommended dose for BELSOMRA is 10 mg, taken no more than once per night. 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 taken no more than once per night.

Special Populations

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.

Use with CNS Depressants

When BELSOMRA is combined with other CNS depressant drugs, dosage reduction of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects.

Dosage Adjustments with CYP3A Inhibitors

When used with moderate CYP3A inhibitors, the recommended dosage of BELSOMRA is 5 mg taken no more than once per night (the dose generally should not exceed 10 mg). BELSOMRA is not recommended for use with strong CYP3A inhibitors.

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DOSAGE FORMS AND STRENGTHS

5 mg tablets are yellow, round, film-coated tablets with “5” on one side and plain on the other side.

10 mg tablets are green, round, film-coated tablets with “33” on one side and plain on the other side.15 mg tablets are white, oval, film-coated tablets with the Merck logo on one side and “325” on the other side.

20 mg tablets are white, round, film-coated tablets with the Merck logo and “335” on one side and plain on the other side.

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CONTRAINDICATIONS

BELSOMRA is contraindicated in patients with narcolepsy.

WARNINGS AND PRECAUTIONS

CNS Depressant Effects and Daytime Impairment

BELSOMRA is a central nervous system (CNS) depressant that 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 (i.e., less than formal testing of daytime wakefulness and/or psychomotor performance).

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. In a study of healthy adults,driving ability was impaired in some individuals taking 20 mg BELSOMRA.

Although pharmacodynamic tolerance or adaptation to some adverse depressant effects of BELSOMRA may develop with daily use, patients using the 20 mg dose of BELSOMRA should be cautioned agains next-day driving and other activities requiring full mental alertness. Patients taking lower doses of BELSOMRA should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA.Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Patients should be advised not to consume alcohol in combination with BELSOMRA because of additive effects.

Dosage adjustments of BELSOMRA and of 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 the recommended dose is taken, if co-administered with other CNS depressants, or if co-administered with other drugs that increase blood levels of BELSOMRA. Patients should be cautioned against driving and other activities requiring complete mental alertness if BELSOMRA is taken in these circumstances.
Because BELSOMRA can cause drowsiness, patients, particularly the elderly, are at higher risk of falls.

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Worsening of Depression/Suicidal Ideation

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 behavioral sign or symptom.
In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides) 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 emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Complex Sleep Behaviors

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as BELSOMRA. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of BELSOMRA, with or without the concomitant use of alcohol and other CNS depressants Discontinue BELSOMRA immediately if a patient experiences a complex sleep behavior.

Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms

Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions by the patient, can occur with the use of BELSOMRA. Prescribers should explain the nature of these events to patients when prescribing BELSOMRA.
Symptoms similar to mild cataplexy can occur, with risk increasing with the dose of BELSOMRA. Suchsymptoms 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 (e.g., laughter or surprise).

Patients with Compromised Respiratory Function

Effect of BELSOMRA on respiratory function should be considered if prescribed to patients with compromised respiratory function. BELSOMRA has not been studied in patients with severe obstructive sleep apnea (OSA) or severe chronic obstructive pulmonary disease (COPD)

Need to Evaluate for Co-morbid Diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or physical disorder and can emerge during the course of treatment with hypnotic drugs such as BELSOMRA.

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ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

*CNS Depressant Effects and Daytime Impairment
*Worsening of Depression/Suicidal Ideation
*Complex Sleep Behaviors [see Warnings and Precautions
*Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms
*Patients with Compromised Respiratory Function

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 3-month controlled efficacy trials (Study 1 and Study 2), 1263 patients were exposed to BELSOMRA including 493 patients who received BELSOMRA 15 mg or 20 mg. In a long-term study, additional patients (n=521) were treated with BELSOMRA at higher than recommended doses, including a total of 160 patients who received BELSOMRA for at least one year.

Adverse Reactions Resulting in Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions for patients treated with 15 mg or 20 mg of BELSOMRA was 3% compared to 5% for placebo. No individual adverse reaction led to discontinuation at an incidence ≥1%.

Most Common Adverse Reactions

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

side Effects

Belsomra (suvorexant) is a selective antagonist for orexin receptors OX1R and OX2R used to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Common side effects of Belsomra include:

headache,
sleepiness,
next day drowsiness,
dizziness,
abnormal dreams,
diarrhea,
dry mouth,
cough, and
upper respiratory tract infection
Belsomra may cause serious side effects that you may not know are happening to you, including “sleep-walking” or doing other activities when you are asleep like eating, talking, having sex, or driving a car. Call your doctor right away if you find out you have done any of these activities after taking Belsomra.

Interactions

CNS-Active Agents

When BELSOMRA was co-administered with alcohol, additive psychomotor impairment was demonstrated. There was no alteration in the pharmacokinetics of BELSOMRA.

Effects of Other Drugs on BELSOMRA

Metabolism by CYP3A is the major elimination pathway for suvorexant.

CYP3A Inhibitors

Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir,telaprevir, telithromycin and conivaptan) is not recommended.
The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g.,amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir,grapefruit juice, imatinib, verapamil). The dose generally should not exceed 10 mg in patients receiving moderate CYP3A inhibitors.

CYP3A Inducers

Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers(e.g., rifampin, carbamazepine and phenytoin). The efficacy of BELSOMRA may be reduced.

Effects of BELSOMRA on Other Drugs

Digoxin

Concomitant administration of BELSOMRA with digoxin slightly increased digoxin levels due to inhibition of intestinal P-gp. Digoxin concentrations should be monitored when co-administering BELSOMRA with digoxin.

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Pregnancy and Lactation

Pregnancy

Risk Summary
Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetaloutcomes.
In animal reproduction studies, oral administration of suvorexant to pregnant rats and rabbits during the period of organogenesis decreased maternal body weight and/or weight gain at doses ≥ 30 and 28 times the maximum recommended human dose (MRHD) of 20 mg based on AUC in the rat and rabbit,respectively. Suvorexant caused decreased fetal weight at doses ≥ 86 times the MRHD based on AUC in the rat and did not cause significant fetal toxicity at doses up to 28 times the MRHD based on AUC in the rabbit. The no observed adverse effect levels (NOAELs) for fetal toxicity are 25 and 28 times the MRHD based on AUC in the rat and rabbit, respectively. Oral administration of suvorexant to pregnant rats during pregnancy and lactation caused decreased maternal and pup body weight or weight gain at approximately 48 times the MRHD based on AUC. The NOAEL for development toxicity in the rat is 25 times the MRHD based on AUC.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Animal Data

Suvorexant was administered orally to pregnant rats during the period of organogenesis in two separate studies at doses of 30, 150, and 1000 mg/kg/day or 30, 80, and 325 mg/kg/day, which are approximately 3 to 93 times the MRHD based on AUC. Suvorexant decreased maternal weights at doses ≥ 150 mg/kg/day and fetal weights at doses ≥ 325 mg/kg/day. The NOAEL for both maternal and fetal toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC.
Suvorexant was administered orally to pregnant rabbits during the period of organogenesis in two separate studies at doses of 40, 100, and 300 mg/kg/day or 50, 150, and 325 mg/kg/day, which are approximately 3 to 70 times the MRHD based on AUC. Suvorexant decreased maternal body weight or weight gain at doses ≥ 150 mg/kg/day. Suvorexant caused excessive maternal toxicity that led to premature deaths at 325 mg/kg/day, which precluded fetal evaluation. Suvorexant did not cause significant fetal toxicity at doses up to 300 mg/kg/day. The NOAELs for maternal and fetal toxicities are 100 mg/kg/day and 300 mg/kg/day, respectively, which are approximately 10 and 28 times the MRHD based on AUC, respectively.
Suvorexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 80,and 200 mg/kg/day, which are approximately 8 to 48 times the MRHD based on AUC. Suvorexant caused maternal toxicity of decreased body weight and weight gain and food consumption at 200 mg/kg/day. At this maternally toxic dose, suvorexant caused decreased weight gain in offspring pups. The NOAEL for maternal and developmental toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC.

Lactation

Risk Summary

There are no data on the presence of suvorexant in human milk, the effects on the breastfed infant or the effects on milk production. Suvorexant and hydroxyl-suvorexant are present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Infants exposed to BELSOMRA through breastmilk should be monitored for excessive sedation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
BELSOMRA and any potential adverse effects on the breastfed infant from BELSOMRA or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Getriatric Use

Of the total number of patients treated with BELSOMRA (n=1784) in controlled clinical safety and efficacy studies, 829 patients were 65 years and over, and 159 patients were 75 years and over. No clinically meaningful differences in safety or effectiveness were observed between these patients and younger patients at the recommended doses.
Because BELSOMRA can increase drowsiness, patients, particularly the elderly, are at a higher risk of falls.

Patients with Compromised Respiratory Function

Effects of BELSOMRA on respiratory function should be considered if prescribed to patients with compromised respiratory function.

 

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