Belsomra

Belsomra is a prescription medication used to treat difficulty in falling and staying asleep (insomnia).

Belsomra belongs to a group of drugs called orexin receptor antagonists. These work by altering the signaling (action) of orexin in the brain. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake.

This medication comes in tablet form and is typically taken once a day, at night. 

A common side effect of Belsomra is drowsiness. Do not drive or operate heavy machinery until you know how Belsomra affects you.

Belsomra is a prescription medication used to treat difficulty in falling and staying asleep (insomnia).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with Belsomra. See the “Belsomra Precautions” section.

A common side effect of Belsomra is drowsiness.

Other possible side effects include:

• Dizziness
• Headache
• Diarrhea
• Dry mouth
• Upper respiratory tract infection
• Abnormal dreams
• Cough

This is not a complete list of Belsomra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone.
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop).
• digoxin (Lanoxin)
• other CNS depressant drugs such as benzodiazepines, opioids, tricyclic antidepressants, and alcohol

This is not a complete list of Belsomra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Belsomra including the following:

• CNS Depressant Effects. Tell your doctor if you notice slowed breathing. Tell your doctor about how you feel in regards to somnolence.
• Daytime somnolence. Patients are at risk for impaired alertness and motor coordination, including impaired driving. The risk increases with dose. Patients taking 20 mg against should take caution during next-day driving and other activities requiring complete mental alertness.
• Behavioral changes. Report any sign of nighttime "sleep-walking" or doing other activities when you are asleep like eating, talking, or driving a car. You may not remember these events when you wake up. The risk of these behaviors increases with the dose of Belsomra used, use of other CNS depressants, and with alcohol.
• Abnormal thinking. Talk to your doctor if you are unable to think clearly or experience abnormal thoughts, such as hallucinations, confusion, or being upset.
• Depression. Worsening of depression or suicidal thinking may occur. Risk increases with dose. Talk to your doctor if you notice any changes in behavior.
• Compromised respiratory function. Talk to your doctor if you notice any breathing problems.
• Sleep paralysis. Sleep paralysis is the inability to perform voluntary muscle movements during sleep.
• Cataplexy-like symptoms. Cataplexy is the most specific symptom of narcolepsy and is a sudden weakness of the muscles of the body, especially the legs but also the face and neck, that is brought on by strong emotion, especially laughing. The risk increases with dose. Such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur both at night and during the day, and may not be associated with an identified triggering event (ex: laughter or surprise).
   

Belsomra can cause drowsiness. Do not drive or operate heavy machinery until you know how Belsomra affects you.

Do not take Belsomra if you:

• are allergic to Belsomra or to any of its ingredients
• have narcolepsy

Grapefruit and grapefruit juice may interact with Belsomra and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Belsomra should be taken on an empty stomach. The effect of Belsomra may be delayed if taken with or soon after a meal.

Before taking Belsomra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Belsomra or to any of its ingredients
• take CNS depressant drugs
• have liver impairment
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• drink alcohol
• have become dependent on medications in the past

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you continue to have trouble falling asleep or staying asleep after 7 to 10 days of treatments with Belsomra. Sleep disturbances and persistent or worsening insomnia could be a sign of other underlying medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Belsomra falls into category C.  There are no well-controlled studies that have been done in pregnant women. Belsomra should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Belsomra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Belsomra.

Take Belsomra exactly as prescribed.

Belsomra comes in tablet form and is taken once every day, at bedtime. Belsomra should be taken within 30 minutes of going to bed and no more than once per night. Take Belsomra with at least 7 hours remaining, before the planned time of awakening.

Take Belsomra on an empty stomach. The effect of Belsomra may be delayed if taken with or soon after a meal.

Avoid alcohol as alcohol may intensify some of the side effects of this medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Belsomra at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age
• your gender

The recommended dose of Belsomra (suvorexant) for the treatment of insomnia is 10 mg. The maximum recommended dose of Belsomra is 20 mg once daily

If you take too much Belsomra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Avoid alcohol while taking Belsomra.
• Store Belsomra at 20°C to 25°C (68°F to 77°F).
• Keep this and all medicines out of the reach of children.