Suvorexant

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What is Suvorexant?[edit | edit source]

  • Suvorexant (BELSOMRA) is an orexin receptor antagonist used for the treatment of insomnia.
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What are the uses of this medicine?[edit | edit source]

  • BELSOMRA is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).

How does this medicine work?[edit | edit source]

  • Suvorexant (soo" voe rex' ant) is an orexin receptor antagonist which is used to treat insomnia.
  • Central nervous system neurons with orexin receptors are involved in wakefulness and are inactive during sleep.
  • Engagement of the orexin receptor results in wakefulness, and loss of the receptor can result in excessive daytime sleepiness and narcolepsy.
  • Inhibition of orexin receptor signaling using suvorexant has been shown to shorten the time to falling asleep and to prolong sleep in patients with sleep-onset and sleep-maintenance insomnia.

Who Should Not Use this medicine ?[edit | edit source]

This medicine cannot be used in patients with:

What drug interactions can this medicine cause?[edit | edit source]

  • When BELSOMRA was co-administered with alcohol, additive psychomotor impairment was demonstrated.
  • 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 efficacy of BELSOMRA may be reduced when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin).
  • Concomitant administration of BELSOMRA with digoxin slightly increased digoxin levels due to inhibition of intestinal P-gp.

Is this medicine FDA approved?[edit | edit source]

  • This medicine is approved in the year 2014.

How should this medicine be used?[edit | edit source]

Recommended Dosage:

  • 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.

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).

Administration

  • Take BELSOMRA exactly as your doctor tells you to take it.
  • Only take BELSOMRA 1 time each night, if needed, within 30 minutes of going to bed.
  • Only take BELSOMRA when you can get a full night's sleep (at least 7 hours).
  • Do not take BELSOMRA if you drank alcohol that evening or before bed.
  • BELSOMRA may be taken with or without a meal. However, BELSOMRA may take longer to work if you take it with or right after meals.
  • Call your doctor if your insomnia (sleep problem) worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
  • If you take too much BELSOMRA, call your doctor right away or get emergency treatment.

What are the dosage forms and brand names of this medicine?[edit | edit source]

This medicine is available in fallowing doasage form: As Tablets, 5 mg, 10 mg, 15 mg, 20 mg

This medicine is available in fallowing brand namesː

  • BELSOMRA

What side effects can this medication cause?[edit | edit source]

The most common side effects of this medicine include:

  • drowsiness the next day after you take BELSOMRA

BELSOMRA may cause serious side effects including:

  • Decreased awareness and alertness
  • worsening depression and suicidal thoughts
  • complex sleep behaviors
  • temporary inability to move or talk (sleep paralysis)
  • temporary weakness in your legs


What special precautions should I follow?[edit | edit source]

  • Do not drink alcohol while taking BELSOMRA. It can increase your chances of getting serious side effects.
  • Do not drive, operate heavy machinery, do anything dangerous or do other activities that require clear thinking after taking BELSOMRA.
  • You may still feel drowsy the next day after taking BELSOMRA. Do not drive or do other dangerous activities until you feel fully awake.
  • Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately evaluate any new behavioral changes.
  • 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, 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. Risk increases with dose.
  • Effect of BELSOMRA on respiratory function should be considered if prescribed to patients with compromised respiratory function.
  • Reevaluate if insomnia persists after 7 to 10 days of treatment.

What to do in case of emergency/overdose?[edit | edit source]

  • There is limited premarketing clinical experience with an overdosage of BELSOMRA.

Management of overdosage:

  • 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.

Can this medicine be used in pregnancy?[edit | edit source]

  • 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 fetal outcomes.

Can this medicine be used in children?[edit | edit source]

  • Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?[edit | edit source]

  • Active ingredient: Suvorexant
  • Inactive ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). The film coating contains: 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.

Who manufactures and distributes this medicine?[edit | edit source]

  • Packager: Merck Sharp & Dohme Corp.

What should I know about storage and disposal of this medication?[edit | edit source]

  • Store BELSOMRA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store in the original package until use, to protect from light and moisture.
  • Keep BELSOMRA and all medicines out of reach of children.
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