"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"...
Doral Consumer (continued)
This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.
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 immediately if any of these unlikely but serious side effects occur: confusion, unusual feelings of well-being (euphoria), uncontrolled movements (tremor), restlessness, memory loss, sweating, mental/mood changes (e.g., hallucinations, agitation, anxiety, unusual/disturbing thoughts, depression, rare thoughts of suicide), increased or vivid dreams, vision changes, fainting.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), unusual paleness, unusual tiredness, fast/pounding/irregular heartbeat, yellowing of the eyes/skin, dark urine.
Some people who take sleep medications have reported getting out of bed and sleepwalking, driving, eating, talking on the phone, or having sex while not fully awake. Often they do not remember these activities. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking quazepam.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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 Doral (quazepam tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking quazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., lorazepam, diazepam); 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: liver disease, kidney disease, mental/mood problems (e.g., depression, panic disorder), lung problems (e.g., pulmonary insufficiency, sleep apnea), seizures, personal or family history of regular use/abuse of drugs/alcohol/other substances.
This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, loss of coordination, and confusion. These side effects can increase the risk of falling.
Quazepam must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy. Other medications in this class have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. If you are a woman of childbearing age, use an effective form of birth control while taking this drug. If you plan to become pregnant, stop taking this drug before doing so. If you become pregnant or think you may be pregnant, inform your doctor immediately.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. 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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