Suvorexant
What is Suvorexant?[edit | edit source]
- Suvorexant (BELSOMRA) is an orexin receptor antagonist used for the treatment of insomnia.
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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