"The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Belsomra is an orexin receptor antagonist and is the first approved drug of t"...
Provigil Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide).
Get medical help right away if you have any very serious side effects, including: chest pain.
A very serious allergic reaction to this drug is rare. However, stop taking modafinil and get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, skin blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, mouth sores, weakness, easy bruising/bleeding, symptoms of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Provigil (modafinil) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking modafinil, tell your doctor or pharmacist if you are allergic to it; or to armodafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as enlarged heart, mitral valve problem, chest pain, heart attack, irregular heartbeat), heart problems after taking stimulant drugs such as amphetamines (including chest pain, irregular heartbeat), high blood pressure, liver problems, mental/mood disorders (such as depression, mania, psychosis), personal or family history of regular use/abuse of drugs/alcohol.
Sleep disorders may reduce your ability to react quickly. Though modafinil helps keep you awake, you still may not be able to safely do things that require quick reactions (such as driving). This drug may also make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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