Suvorexant

What is Suvorexant?

• Suvorexant (BELSOMRA) is an orexin receptor antagonist used for the treatment of insomnia.

What are the uses of this medicine?

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

How does this medicine work?

• 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 ?

This medicine cannot be used in patients with:

• narcolepsy

What drug interactions can this medicine cause?

• 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?

• This medicine is approved in the year 2014.

How should this medicine be used?

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?

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?

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?

• 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?

• 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?

• 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?

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

What are the active and inactive ingredients in this medicine?

• 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?

• Packager: Merck Sharp & Dohme Corp.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Suvorexant
• FDA Suvorexant

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