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How should this medicine be used?
Suvorexant comes as a tablet to take by mouth. It is usually taken once a day, if needed, no earlier than 30 minutes before bedtime. Suvorexant may be taken with or without food but will begin to work faster if taken on an empty stomach. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take suvorexant exactly as directed. Never take more than one dose of suvorexant per day even if you are still having trouble falling asleep or staying asleep.
You will probably become very sleepy soon after you take suvorexant and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take the medication and to stay in bed for at least 7 hours. Do not take suvorexant if you will be unable to remain asleep for the required number of hours after taking the medication. If you get up too soon after taking suvorexant, you may experience drowsiness and difficulty driving or performing tasks that require alertness.
Your sleep problems should improve within 7 to 10 days after you start taking suvorexant. Call your doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment.
Your doctor will probably start you on a low dose of suvorexant and may gradually increase your dose if your insomnia does not improve. Your doctor may also decrease your dose of suvorexant or tell you to stop taking the medication if it makes you feel too drowsy during the day.
Suvorexant may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with suvorexant and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
What should I do if I forget a dose?
This medication is usually taken as needed. You may take suvorexant even if it is later than the usual time, as long as you will be able to remain in bed for the required number of hours after you take it.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Suvorexant is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Belsomra comes in 5 mg, 10 mg, 15 mg, and 20 mg strengths. You should not take more than 20 milligrams of Belsomra in one day.
The medication should be taken within 30 minutes of going to bed. The Belsomra tablets can be taken with or without a meal, but the medication may take longer to work if you take it with meals.
If you suspect an overdose, you should contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.
Missed Dose of Belsomra
If you miss a dose of Belsomra, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of the medication at the same time.
Merck Sharp & Dohme Corp.
Belsomra Drug Class
Belsomra is part of the drug class:
Other hypnotics and sedatives
Belsomra and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Belsomra falls into category C. There are no well-controlled studies that have been done in pregnant women. Belsomra should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.
Take Belsomra exactly as prescribed.
Belsomra comes in tablet form and is taken once every day, at bedtime. Belsomra should be taken within 30 minutes of going to bed and no more than once per night. Take Belsomra with at least 7 hours remaining, before the planned time of awakening.
Take Belsomra on an empty stomach. The effect of Belsomra may be delayed if taken with or soon after a meal.
Avoid alcohol as alcohol may intensify some of the side effects of this medication.
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Belsomra at the same time.
- Avoid alcohol while taking Belsomra.
- Store Belsomra at 20°C to 25°C (68°F to 77°F).
- Keep this and all medicines out of the reach of children.
What happens if I miss a dose?
Since suvorexant is taken only at bedtime, you will not be on a frequent dosing schedule.
Uses for Belsomra
Management of insomnia characterized by difficulty with sleep onset and/or sleep maintenance.1 3 6
Decreases sleep latency and improves sleep maintenance in patients with primary insomnia receiving therapy for up to 3 months.1 3 4 Generally safe and well tolerated and reportedly effective with nightly use for up to 1 year.5
Belsomra Dosage and Administration
Administer no more than once per night, within 30 minutes of bedtime.1
May administer without regard to meals; however, administration with or immediately after a meal decreases rate of absorption and may delay onset of effect.1
Use only if ≥7 hours remain before planned time of awakening.1
Use smallest effective dosage.1
Concomitant use with certain drugs (e.g., CNS depressants, CYP3A inhibitors) is not recommended or may require dosage adjustment.1 (See Interactions.)
10 mg once daily.1 If 10 mg is well tolerated but ineffective, may increase dosage but do not exceed 20 mg once daily.1
Maximum 20 mg once daily.1
No dosage adjustment necessary in patients with mild to moderate hepatic impairment.1
Not adequately studied in patients with severe hepatic impairment; use not recommended.1
Dosage adjustment not necessary.1
Dosage adjustment not necessary based solely on age.1 10
Dosage adjustment generally not necessary based solely on gender; use caution when increasing dosage in obese women (body mass index [BMI] >30 kg/m2).1 (See Absorption: Special Populations, under Pharmacokinetics.)
Cautions for Belsomra
Narcolepsy.1 (See Actions and also see Narcolepsy-like Events under Cautions.)
CNS Depressant Effects and Next-day Impairment
CNS depressant; may impair daytime wakefulness even when used as prescribed.1
May impair ability to drive a motor vehicle and may increase risk of falling asleep while driving.1 Patients receiving the 20-mg dose should avoid driving or engaging in other activities that require complete mental alertness the day after use.1 Driving impairment also possible in patients receiving lower dosages.1 (See Advice to Patients.) If daytime somnolence develops in patients who drive, discontinue drug or decrease dosage.1
Risk of next-day impairment is increased if drug is administered with less than a full night of sleep remaining, if a higher than recommended dose is administered, or if used concomitantly with other CNS depressants or with drugs capable of increasing suvorexant concentrations.1 (See Interactions.)
Monitor patients for excessive somnolence and CNS depression; however, impairment may occur in the absence of symptoms and may not be reliably detected by ordinary clinical examination (i.e., formal psychomotor testing may be required).1 CNS depressant effects may persist for up to several days after discontinuance.1
Concomitant use with other CNS depressants (e.g., alcohol, benzodiazepines, opiates, tricyclic antidepressants) increases the risk of CNS depression.1 (See Interactions.)
Adequate Patient Evaluation
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.1
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric, physical, and/or medical condition that requires evaluation.1
Abnormal Thinking and Behavioral Changes
Abnormal thinking and behavioral changes (e.g., amnesia, anxiety, hallucinations, other neuropsychiatric symptoms) reported in patients receiving hypnotic agents.1
Complex behaviors such as sleep-driving (i.e., driving while not fully awake after taking a hypnotic agent), preparing and eating food, making phone calls, or having sex with no memory of the event also reported in patients receiving hypnotic agents.1
Complex behaviors may occur in hypnotic agent-naive or -experienced patients.1
Concomitant use of alcohol and other CNS depressants may increase the risk of complex behaviors.1
Strongly consider discontinuing drug in patients who report any complex sleep behavior.1
Worsening of Depression and Suicidality Risk
Dose-dependent increase in suicidal ideation observed in clinical studies.1
Worsening of depression and suicidal thoughts and actions (including completed suicides) reported in primarily depressed patients receiving sedative and hypnotic agents.1 Suicidal tendencies may be present; intentional overdosage more frequent in such patients.1 Protective measures may be required.1 Prescribe and dispense drug in the smallest feasible quantity.1
Evaluate patient immediately if emergence of suicidality or any new behavioral abnormalities occurs.1
Patients with Compromised Respiratory Function
If used in patients with compromised respiratory function, consider possible effects on respiratory function.1 Respiratory depressant effects in patients with mild to moderate obstructive sleep apnea (OSA) or COPD cannot be excluded; not studied in patients with severe OSA or COPD.1
No respiratory depressant effect observed in healthy individuals with normal respiratory function after single doses up to 150 mg.1
Sleep paralysis (inability to move or speak for up to several minutes during sleep-wake transition) and hypnagogic/hypnopompic hallucinations reported.1 3 4 5
Dosage-dependent, mild cataplexy-like symptoms (e.g., leg weakness lasting from seconds to a few minutes) may occur at night and/or during the day; may not be associated with an identified triggering event (e.g., laughter, surprise).1 (See Advice to Patients.)
Abuse Potential and Dependence
Abuse potential of high suvorexant doses (40–150 mg) appears to be similar to that of high zolpidem tartrate doses (15–30 mg).1 Patients with a history of drug or alcohol abuse or addiction are at increased risk of abuse and addiction; use only with careful surveillance in such patients.1
Discontinuance following chronic administration did not produce withdrawal symptoms or clear evidence of rebound insomnia.1 Does not appear to produce physical dependence.1
Distributed into milk in rats; not known whether distributed into human milk.1 Use with caution.1Pediatric Use
Safety and efficacy not established in pediatric patients.1Geriatric Use
At recommended dosages, no overall differences in safety or efficacy relative to younger adults.1
Balance impairment observed when geriatric individuals were awakened 90 minutes after a 30-mg dose; no memory impairment observed when awakened 4 hours after the dose.1 9Hepatic Impairment
Dosage adjustment not necessary in patients with mild or moderate hepatic impairment.1
Not adequately studied in patients with severe hepatic impairment; use not recommended.1Renal Impairment
Dosage adjustment not necessary in patients with renal impairment.1Gender
Somnolence, headache, abnormal dreams, dry mouth, cough, and upper respiratory infection are at least twice as common in women as in men.1
Systemic exposure and peak plasma concentration are higher in women compared with men.1 (See Absorption: Special Populations, under Pharmacokinetics and also see Gender under Dosage and Administration.)Obesity
Systemic exposure and peak plasma concentration are higher in obese patients (BMI >30 kg/m2) compared with nonoverweight patients (BMI ≤25 kg/m2).1 (See Absorption: Special Populations, under Pharmacokinetics and also see Gender under Dosage and Administration.)
Common Adverse Effects
Somnolence,1 3 headache,1 3 dizziness,1 3 abnormal dreams,1 3 cough,1 3 diarrhea,1 3 dry mouth,1 3 upper respiratory tract infection.1 3
20–25°C (may be exposed to 15–30°C).1 Store in original package until use to protect from light and moisture.1
What do I need to tell my doctor BEFORE I take Belsomra?
- If you have an allergy to Belsomra (suvorexant) or any part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Falling asleep when you do not expect to (narcolepsy) or liver problems.
- If you are taking any of these drugs: Another drug to help you sleep, boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, or telithromycin.
This is not a list of all drugs or health problems that interact with Belsomra.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Belsomra is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Belsomra or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Belsomra. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: October 4, 2017
Belsomra is contraindicated in patients with narcolepsy.
The following serious adverse reactions are discussed in greater detail in other sections:
- CNS depressant effects and daytime impairment [see Warnings and Precautions (5.1)]
- Abnormal thinking and behavioral changes [see Warnings and Precautions (5.3)]
- Worsening of Depression/Suicidal ideation [see Warnings and Precautions (5.4)]
- Sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms [see Warnings and Precautions (5.6)]
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 (see Table 1).
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.
|Patients Treated||Belsomra |
|For ≥ 1 Day (n)||202||291|
|Mean Age (years)||70||45|
|For ≥ 3 Months (n)||118||172|
The pooled safety data described below (see Table 2) reflect the adverse reaction profile during the first 3 months of treatment.
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%).
Table 2 shows the percentage of patients with adverse reactions during the first three months of treatment, based on the pooled data from 3-month controlled efficacy trials (Study 1 and Study 2).
At doses of 15 or 20 mg, the incidence of somnolence was higher in females (8%) than in males (3%). Of the adverse reactions reported in Table 2, the following occurred in women at an incidence of at least twice that in men: headache, abnormal dreams, dry mouth, cough, and upper respiratory tract infection.
The adverse reaction profile in elderly patients was generally consistent with non-elderly patients. The adverse reactions reported during long-term treatment up to 1 year were generally consistent with those observed during the first 3 months of treatment.
(20 mg in non-elderly or 15 mg in elderly patients)
|Infections and Infestations|
|Upper respiratory tract infection||1||2|
|Nervous System Disorders|
|Respiratory, Thoracic and Mediastinal Disorders|
Dose Relationship for Adverse Reactions
There is evidence of a dose relationship for many of the adverse reactions associated with Belsomra use, particularly for certain CNS adverse reactions.
In a placebo-controlled crossover study (Study 3), non-elderly adult patients were treated for up to one month with Belsomra at doses of 10 mg, 20 mg, 40 mg (2 times the maximum recommended dose) or 80 mg (4 times the maximum recommended dose). In patients treated with Belsomra 10 mg (n=62), although no adverse reactions were reported at an incidence of ≥2%, the types of adverse reactions observed were similar to those observed in patients treated with Belsomra 20 mg. Belsomra was associated with a dose-related increase in somnolence: 2% at the 10 mg dose, 5% at the 20 mg dose, 12% at the 40 mg dose, and 11% at the 80 mg dose, compared to <1% for placebo. Belsomra was also associated with a dose-related increase in serum cholesterol: 1 mg/dL at the 10 mg dose, 2 mg/dL at the 20 mg dose, 3 mg/dL at the 40 mg dose, and 6 mg/dL at the 80 mg dose after 4 weeks of treatment, compared to a 4 mg/dL decrease for placebo.
There is limited premarketing clinical experience with an overdosage of Belsomra. In clinical pharmacology studies, healthy subjects who were administered morning doses of up to 240 mg of suvorexant showed dose-dependent increases in the frequency and duration of somnolence.
General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. As in all cases of drug overdose, vital signs should be monitored and general supportive measures employed. The value of dialysis in the treatment of overdosage has not been determined. As suvorexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of suvorexant.
As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. Consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.
Belsomra tablets contain suvorexant, a highly selective antagonist for orexin receptors OX1R and OX2R.
Suvorexant is described chemically as:
Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is:
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: polyvinylpyrrolidone/vinyl acetate copolymer (copovidone), microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
In addition, the film coating contains the following inactive ingredients: lactose monohydrate, hypromellose, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide yellow and iron oxide black, and the film coating for the 10 mg tablets also contains iron oxide yellow and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Card Carton
This package contains 30 Tablets in 3 Blister Cards.
Each Blister Card contains 10 Tablets.
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 20 mg suvorexant.
USUAL DOSAGE: See Package Insert.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled
Room Temperature]. Store in the original package until use, to protect from light and moisture.
Selling or giving away Belsomra® may harm others and is against the law.
suvorexant tablet, film coated
suvorexant tablet, film coated
suvorexant tablet, film coated
suvorexant tablet, film coated
|Labeler - Merck Sharp & Dohme Corp. (001317601)|