Suvorexant (Belsomra)

Trade Name : BELSOMRA

Merck Sharp & Dohme Corp.

TABLET, FILM COATED

Strength 5 mg/1

Storage and handling for BELSOMRA

SUVOREXANT Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Suvorexant (Belsomra) which is also known as BELSOMRA and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 5 mg/1 per ml. Read more

Suvorexant (Belsomra) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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BELSOMRA (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ().

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Use the lowest dose effective for the patient ().
Recommended dose is 10 mg, no more than once per night taken 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, not to exceed 20 mg once daily (, ).
Time to effect may be delayed if taken with or soon after a meal ().

Tablets, 5 mg, 10 mg, 15 mg, 20 mg ().

BELSOMRA is contraindicated in patients with narcolepsy.
BELSOMRA is contraindicated in patients with narcolepsy ().

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CNS Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness ().
Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately evaluate any new behavioral changes ().
Complex Sleep Behaviors: Behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs ().
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of BELSOMRA. Risk increases with dose ().
Compromised Respiratory Function: Effect on respiratory function should be considered (, ).
Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment ().

The following serious adverse reactions are discussed in greater detail in other sections:
The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence ().
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once per night if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors (, ).
Strong CYP3A inducers: Efficacy may be reduced ().
Digoxin: Monitor digoxin concentrations ().

Patients with severe hepatic impairment: Not recommended ().

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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, 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-triazol-2-yl)phenyl]methanone
Its empirical formula is CHClNO 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: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone).
In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.

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Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2014-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk4305-t-2001r004

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NDC 0006-0005-30
This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets.
Belsomran (suvorexant) tablets CIV 5 mg
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 5 mg suvorexant.
USUAL DOSAGE: See Package Insert.
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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.
Rx only

NDC 0006-0033-30
This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets.
Belsomran (suvorexant) tablets CIV 10 mg
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 10 mg suvorexant.
USUAL DOSAGE: See Package Insert.
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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.
Rx only

NDC 0006-0325-30
This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets.
Belsomran (suvorexant) tablets CIV 15 mg
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 15 mg suvorexant.
USUAL DOSAGE: See Package Insert.
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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.
Rx only

NDC 0006-0335-30
This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets.
Belsomran (suvorexant) tablets CIV 20 mg
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 20 mg suvorexant.
USUAL DOSAGE: See Package Insert.
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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.
Rx only

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