Belsomra label

Belsomra

Belsomra Recall

Get an alert when a recall is issued.

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

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

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

BELSOMRA tablets contain suvorexant, a highly selective antagonist for orexin receptors OX1R and OX2R.

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 C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is:

Chemical Structure

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.

Add Info
Add to My Alerts
Report Side Effect
Leave a Review
Navigate to :
Belsomra Recall
Side Effects & Adverse Reactions
Legal Issues
FDA Safety Alerts
Manufacturer Warnings
FDA Labeling Changes
Uses
History
Other Information
Manufacturers
Trending Topics

Belsomra Manufacturers

  • Merck Sharp & Dohme Corp.
    Belsomra | Merck Sharp & Dohme Corp.
    No Recall

    Belsomra | Merck Sharp & Dohme Corp.

    Belsomra | Merck Sharp & Dohme Corp.
    2.1 Dosing Information

    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.

    2.2 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 [see Clinical Pharmacology (12.3)].

    2.3 Use with CNS Depressants

    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 [see Warnings and Precautions (5.1)].

    2.4 Use with CYP3A Inhibitors

    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 [see Drug Interactions (7.2)].

    2.5 Food Effect

    Time to effect of BELSOMRA may be delayed if taken with or soon after a meal.

Login To Your Free Account