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Belsomra (Suvorexant) - Complete Drug Information

Belsomra (Suvorexant) is a dual orexin receptor antagonist (DORA) that is used to treat patients with insomnia. Insomnia is defined as either difficulty with the onset of sleep or in the maintenance of sleep.

Belsomra (Suvorexant) dose in Adults

Belsomra (Suvorexant) dose in the treatment of Insomnia:

Note: Use the lowest effective dose for the patient.

Usual dose:
- 10 milligrammes given once daily, 30 minutes before bedtime.
- In the event that the 10 mg dose is well tolerated but ineffective, the dose may be increased to a maximum of 20 mg once daily.
- The 20 mg daily maximum dose
Dosage adjustment in concomitant therapy:
- Crepitant, atazanavir, amprenavir, aprepitant, diltiazem, ciprofloxacin, erythromycin, grapefruit juice, fluconazole, fosamprenavir, imatinib, and verapamil are examples of moderate CYP3A inhibitors.
  - A maximum daily dose of 10 mg once daily; the standard dose is 5 mg once daily
- Itraconazole, ketoconazole, clarithromycin, posaconazole, ritonavir, nefazodone, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, conivaptan, and telithromycin are examples of strong CYP3A inhibitors.
  - Use of Suvorexant is not advised.

CNS depressants:
- Suvorexant or other CNS depressants must have their dosage changed.

Belsomra (Suvorexant) dose in Children

Not recommended for use in children.

Belsomra (Suvorexant) Pregnancy Risk Factor C

Some studies on animal reproduction have shown adverse effects.

Use of suvorexant while breastfeeding

It is unknown if breast milk contains suvorexant.
If the product is being administered to a nursing mother, it is recommended that caution be taken.

Belsomra (Suvorexant) dose in Kidnet Disease:

No dosage adjustment necessary.

Belsomra (Suvorexant) dose in Liver Disease:

In Liver disease, Belsomra (Suvorexant), dose:
- Mild to moderate impairment
  - There is no need to adjust the dosage.
- Severe impairment
  - It is not recommended and has not been tested.

Common Side Effects of Belsomra (Suvorexant) Include:

Central nervous system:
- Drowsiness

Less Common Side Effects of Belsomra (Suvorexant) Include:

Central nervous system:
- Headache
- Dizziness
- Abnormal Dreams
Gastrointestinal:
- Diarrhea
- Xerostomia
Respiratory:
- Cough
- Upper Respiratory Tract Infection

Rare side effects of Belsomra (Suvorexant)

Central Nervous System:
- Abnormal Behavior
- Abnormality In Thinking
- Amnesia
- Behavioral Changes
- Cataplexy (Mild; With Or Without Triggering Event)
- Central Nervous System Depression
- Daytime Sedation
- Exacerbation Of Depression
- Hallucination (Including Hypnagogic And Hypnopompic)
- Sleep Driving
- Sleep Paralysis
- Suicidal Ideation
Endocrine & Metabolic:
- Increased Serum Cholesterol
Neuromuscular & Skeletal:
- Lower Extremity Weakness (Cataplexy-Like Symptoms

Contraindication to Belsomra (Suvorexant) Include:

Narcolepsy

Warnings and precautions

Abnormal thinking/behavioral changes
- Hypnotics are frequently linked to alterations in deviant behaviour or thought (eg anxiety, amnesia and hallucinations).
Depression in the CNS:
- Patients should exercise caution while engaging in activities that could result in CNS depression, which can impair cognition and physical function.
- Suvorexant should be administered only to patients who are able to remain in bed for at least seven hours before becoming active again.
- Patients who drive should discontinue or decrease their dose if somnolence is present during the day.
REM Sleep Effects:
- The inability to speak or move for many minutes during sleep-wake transitions is a defining characteristic of sleep paralysis.
- There can also be cataplexy and hypnagogic/hypnopompic hallucinations.
- A limb weakness that lasts anywhere from a few seconds to a few minutes is one of the symptoms of cataplexy.
- They can happen day or night and are typically not connected to any trigger events (eg laughter, surprise).
Activities that are sleep-related:
- The likelihood of risky sleep-related behaviours including driving, preparing food, eating, and making phone calls while you sleep increases.
- Patients who have experienced any sleep-related episode should discontinue treatment.
Depression
- Patients with depression or worsening depression should exercise caution.
- The use of hypnotics has been linked to suicide or suicidal thoughts.
- Intentional overdose is a serious problem in this population.
- It is best to use the minimum amount that will effectively treat each patient.
Use of drugs:
- Patients with a history or drug dependence should exercise caution.
- Suvorexant prolonged use can increase the risk of abuse in patients who have a history or use other drugs together.
Hepatic impairment
- Patients with severe hepatic impairment should not use it (has not been tested).
Respiratory disease
- Patients with COPD, respiratory compromise, and sleep apnea should be cautious.

Suvorexant: Drug Interaction

Risk Factor C (Monitor therapy)
Alizapride	CNS depressants may have an enhanced CNS depressant impact.
Bosentan	May lower the serum level of CYP3A4 substrates (High risk with Inducers).
Brimonidine (Topical)	CNS depressants may have an enhanced CNS depressant impact.
Bromopride	CNS depressants may have an enhanced CNS depressant impact.
Cannabidiol	CNS depressants may have an enhanced CNS depressant impact.
Cannabis	CNS depressants may have an enhanced CNS depressant impact.
Chlorphenesin Carbamate	May enhance the adverse/toxic effect of CNS Depressants.
Clofazimine	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
CYP3A4 Inducers (Moderate)	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Deferasirox	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Dimethindene (Topical)	May enhance the CNS depressant effect of CNS Depressants.
Dronabinol	CNS depressants may have an enhanced CNS depressant impact.
Erdafitinib	May lower the serum level of CYP3A4 substrates (High risk with Inducers).
Erdafitinib	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Fosaprepitant	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Ivosidenib	May lower the serum level of CYP3A4 substrates (High risk with Inducers).
Kava Kava	May enhance the adverse/toxic effect of CNS Depressants.
Larotrectinib	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Lofexidine	CNS depressants may have an enhanced CNS depressant impact. Management: Separate drug interaction monographs go into further detail about the medications indicated as exceptions to this book.
Magnesium Sulfate	CNS depressants may have an enhanced CNS depressant impact.
Melatonin	May intensify hypnotics' sedative effects (Nonbenzodiazepine).
MetyroSINE	The sedative effects of metyroSINE may be strengthened by CNS depressants.
Minocycline	CNS depressants may have an enhanced CNS depressant impact.
Nabilone	CNS depressants may have an enhanced CNS depressant impact.
Palbociclib	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Piribedil	Piribedil's CNS depressing effects may be enhanced by other CNS depressants.
Pramipexole	The sedative effects of pramipexole might be enhanced by CNS depressants.
ROPINIRole	The sedative effects of CNS depressants may increase those of ROPINIRole.
Rotigotine	Rotigotine's sedative effects may be boosted by CNS depressants.
Rufinamide	CNS depressants' harmful or toxic effects could be increased. Particularly, drowsiness and lightheadedness could be worsened.
Sarilumab	May lower the serum level of CYP3A4 substrates (High risk with Inducers).
Selective Serotonin Reuptake Inhibitors	Selective serotonin reuptake inhibitors may have a worsened or more hazardous effect when taken with CNS depressants. Particularly, there may be an increased risk of psychomotor impairment.
Siltuximab	May lower the serum level of CYP3A4 substrates (High risk with Inducers).
Simeprevir	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Tetrahydrocannabinol	May enhance the CNS depressant effect of CNS Depressants.
Tetrahydrocannabinol and Cannabidiol	May enhance the CNS depressant effect of CNS Depressants.
Tocilizumab	May enhance the serum level of CYP3A4 substrates (High risk with Inducers).
Risk Factor D (Consider therapy modification)
Blonanserin	Blonanserin's CNS depressing effects may be enhanced by other CNS depressants.
Buprenorphine	CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants.
Chlormethiazole	May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used.
CNS Depressants	May intensify Suvorexant's CNS depressive effects. Treatment: Suvorexant and/or any other CNS depressant dosage reduction may be required. Suvorexant shouldn't be taken with alcohol, and it shouldn't be taken for sleeplessness with any other medication either.
CYP3A4 Inducers (Strong)	May speed up CYP3A4 substrate metabolism (High risk with Inducers). Management: Take into account a substitute for one of the interfering medications. Certain contraindications may apply to some combinations. the relevant manufacturer's label.
CYP3A4 Inhibitors (Moderate)	Suvorexant serum concentration can rise. Treatment: Suvorexant is administered at a dose of 5 mg per day to patients who are on a mild CYP3A4 inhibitor. If more dosage is required for effectiveness, the maximum amount per day is 10 mg.
Dabrafenib	May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: Where possible, look for substitutes for the CYP3A4 substrate. If concurrent therapy cannot be avoided, pay special attention to the substrate's clinical consequences (particularly therapeutic effects).
Droperidol	CNS depressants may have an enhanced CNS depressant impact. Consider lowering the dosage of droperidol or other CNS drugs (such as opioids or barbiturates) when they are used concurrently. In separate drug interaction monographs, exceptions to this monograph are covered in more detail.
Enzalutamide	May lower the serum level of CYP3A4 substrates (High risk with Inducers). Treatment: Enzalutamide should not be used concurrently with CYP3A4 substrates that have a limited therapeutic index. Enzalutamide use, like with the use of any other CYP3A4 substrate, should be done cautiously and under close observation.
Flunitrazepam	Flunitrazepam's CNS depressing effects may be enhanced by other CNS depressants.
HYDROcodone	The CNS depressive action of HYDROcodone may be enhanced by CNS depressants. Management: Whenever feasible, refrain from using hydrocodone and benzodiazepines or other CNS depressants concurrently. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together.
Lorlatinib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences.
Methotrimeprazine	CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established.
Mitotane	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane.
OxyCODONE	CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.
Perampanel	May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination.
St John's Wort	May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: Take into account a substitute for one of the interfering medications. Certain contraindications may apply to some combinations. the relevant manufacturer's label.
Stiripentol	May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). Management: Due to the increased potential for side effects and toxicity, stiripentol should not be used with CYP3A4 substrates that are thought to have a narrow therapeutic index. Use of stiripentol with any CYP3A4 substrate necessitates closer observation.
Tapentadol	CNS depressants may have an enhanced CNS depressant impact. Treatment: When feasible, refrain from using tapentadol and benzodiazepines or other CNS depressants simultaneously. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together.
Zolpidem	CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol.
Risk Factor X (Avoid combination)
Alcohol (Ethyl)	May enhance the CNS depressant effect of Suvorexant.
Azelastine (Nasal)	Azelastine's CNS depressing impact may be amplified by CNS depressants (Nasal).
Bromperidol	CNS depressants may have an enhanced CNS depressant impact.
Conivaptan	May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors).
CYP3A4 Inhibitors (Strong)	Suvorexant serum concentration can rise.
Fusidic Acid (Systemic)	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Idelalisib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Orphenadrine	CNS Depressants may enhance the CNS depressant effect of Orphenadrine.
Oxomemazine	May enhance the CNS depressant effect of CNS Depressants.
Paraldehyde	CNS Depressants may enhance the CNS depressant effect of Paraldehyde.
Sodium Oxybate	Hypnotics (Nonbenzodiazepine) may intensify Sodium Oxybate's CNS depressive effects.
Thalidomide	The CNS depressing effect of thalidomide may be enhanced by CNS depressants.

Monitoring Parameters while using Belsomra (Suvorexant):

Daytime alertness
respiratory rate
behavior profile
tolerance
abuse
dependence

How to administer Belsomra (Suvorexant)?

Give it to yourself orally 30 minutes before going to bed and at least 7 hours before your expected wake-up time. Eating slows down the start of activity. Never offer commands during or immediately after a meal.

Mechanism of action of Suvorexant (Belsomra):

Suvorexant, which suppresses wake-promoting neuropeptides OrexinA/Orexin B, blocks their binding to OX1R or OX2R.
Potentially adverse effects, such as cataplexy/narcolepsy, can also be caused by antagonism to orexin receptors.

The beginning of actionIt takes 30 minutes AbsorptionHigher doses cause a decrease in the effectiveness of this drug. DistributionIs49 L Protein bindingIs >99% Metabolism CYP3A is the predominant hepatic metabolite, with a small contribution from CYP2C19. The hydroxy suvorexant metabolite however is an inactive metabolite. BioavailabilityIs 82% Eliminating half-lifeIt takes 12 hours Terminal with half-lifeIs15 hours (In healthy subjects, range is between 10 and 22 hours). (In moderate hepatic diseases, range is between 11 to 49 hours.

Time to reach peak2 hours (range: 30-60 minutes to 6 hours); Delayed 1.5 hour if administered with a meal

ExcretionThe average urine content is 23%, while the average in feces is 66%

International Brands of Suvorexant:

Belsomra
Insoma
Silubra
Somarant
Suvorex
Xantosuvan

Belsomra (Suvorexant) Brands in Pakistan:

Belsomra (Suvorexant) is not available in Pakistan.