Belsomra (suvorexant) is a sleep medicine that helps regulate your sleep and wake cycle.
Belsomra is used to treat insomnia (trouble falling asleep or staying asleep).
Belsomra may also be used for purposes not listed in this medication guide.
Important information
You should not use Belsomra if you have narcolepsy.
Before taking this medicine
You should not use Belsomra if you are allergic to suvorexant, or if you have narcolepsy.
Belsomra may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
To make sure Belsomra is safe for you, tell your doctor if you have:
-
a history of depression or thoughts about suicide;
-
sleep apnea (breathing stops during sleep); or
-
chronic obstructive pulmonary disease (COPD) or other breathing disorder.
FDA pregnancy category C. It is not known whether suvorexant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether suvorexant passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Belsomra is not approved for use by anyone younger than 18 years old.
How should I take Belsomra?
Take Belsomra exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Never use this medicine in larger amounts, or for longer than prescribed.
Belsomra should be taken only once per night. Take this medicine at bedtime or within 30 minutes before you go to bed.
Belsomra will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 hours to dedicate to sleeping.
Avoid taking Belsomra shortly after eating a meal. The medicine may not work as well during this time.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens, stop taking Belsomra and talk with your doctor about another treatment for your sleep disorder.
It may take longer for you to wake up, speak, or move around the morning after taking this medicine. You may have hallucinations or feel like you are still dreaming for a several minutes after you wake up.
Call your doctor if your insomnia symptoms do not improve, or if they get worse after using Belsomra for 7 to 10 nights in a row.
Store at room temperature away from moisture, heat, and light.
Keep track of the amount of medicine used from each new bottle. Belsomra is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Belsomra dosing information
Usual Adult Dose for Insomnia:
10 mg orally once a day at bedtime
Maximum dose: 20 mg once a day
Comments:
-Take within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening.
-If 10 mg is well-tolerated but not effective, the dose can be increased.
-Time to effect may be delayed if taken with or soon after a meal.
Use: Insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
What happens if I miss a dose?
Since Belsomra is taken only at bedtime, you will not be on a frequent dosing schedule.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Belsomra?
Do not drive or do anything that requires you to be alert if it has been less than 8 hours since you took Belsomra.
Belsomra can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Until you know how this medicine will affect you during waking hours, be careful if you drive, operate machinery or do anything that requires you to be awake and alert.
Do not drink alcohol while you are taking suvorexant. Alcohol can increase some of the side effects of this medicine, including drowsiness.
Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Belsomra side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Belsomra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Belsomra and call your doctor at once if you have:
You may be more likely to have side effects if you are overweight.
Common Belsomra side effects may include:
-
daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
-
amnesia or forgetfulness;
-
a weak feeling in your legs; or
-
strange dreams.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Belsomra?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Belsomra, especially:
-
digoxin;
-
imatinib;
-
nefazodone;
-
St. John"s wort;
-
verapamil;
-
an antibiotic - ciprofloxacin, clarithromycin, rifampin, telithromycin;
-
antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;
-
hepatitis C medications - boceprevir, telaprevir;
-
HIV/AIDS medication - atazanavir, cobicistat (Stribild, Tybost), delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir; or
-
seizure medication - carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone.
This list is not complete. Other drugs may interact with suvorexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
