Suvorexant Oral tablet
What is this medicine?
SUVOREXANT (su-vor-EX-ant) is used to treat insomnia. This medicine helps you to fall asleep and sleep through the night.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
history of a drug or alcohol abuse problem
history of daytime sleepiness
history of sudden onset of muscle weakness (cataplexy)
lung or breathing disease
suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
an unusual or allergic reaction to suvorexant, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth within 30 minutes of going to bed. Do not take it unless you are able to stay in bed a full night before you must be active again. Follow the directions on the prescription label. For best results, it is better to take this medicine on an empty stomach. Do not take your medicine more often than directed. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.
What may interact with this medicine?
antiviral medicines for HIV or AIDS
certain antibiotics like ciprofloxacin, clarithromycin, erythromycin, telithromycin
certain medicines for depression or psychotic disturbances
certain medicines for fungal infections like ketoconazole, posaconazole, fluconazole, or itraconazole
medicines for anxiety or sleep
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Do not increase the dose on your own. Talk to your doctor if your insomnia worsens or is not better within 7 to 10 days.
After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep, since your risk of doing these sleep-related activities will be increased.
Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) and do not drive or perform other activities requiring full alertness within 8 hours of a dose. Do not drive, use machinery, or do anything that needs mental alertness the day after you take the 20 mg dose of this medicine. The use of lower doses (10 mg) also has the potential to cause driving impairment the next day. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
feeling faint or lightheaded, falls
inability to move or speak for up to several minutes while you are going to sleep or waking up
periods of leg weakness lasting from seconds to a few minutes
problems with balance, speaking, walking
restlessness, excitability, or feelings of agitation
unusual activities while asleep like driving, eating, making phone calls
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert