"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).
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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
SODIUM OXYBATE SOLUTION - ORAL
COMMON BRAND NAME(S): Xyrem
WARNING: Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It must be used only for the purpose that your doctor prescribes. It is against the law to use this drug for any other purposes. Abuse and even approved use can result in seizures, severe difficulty breathing, confusion, depression, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).
Only patients who take part in the Xyrem Success Program may receive treatment with this medication. Before you receive your prescription, you must register with this program, and your doctor's office must provide educational materials to you. Your doctor must go over this material with you and instruct you how to use this medication safely and effectively. Only doctors enrolled in the Xyrem Success Program may prescribe sodium oxybate, and only the central pharmacy (not your local pharmacy) may dispense it.
USES: This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. It can decrease symptoms such as daytime sleepiness, unwanted daytime naps/sleep attacks, and nighttime awakening. It also reduces the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can also occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using sodium oxybate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth in 2 separate doses at bedtime (at least 2 hours after eating) as directed by your doctor. Prepare your 2 doses as instructed in the Medication Guide. The doses must be diluted with 2 ounces (60 milliliters) of water. Take the first dose at bedtime while in bed. Set an alarm clock to awaken you for the second dose in 4 hours. If you wake up before the alarm and it has been at least 2-and-a-half hours after the first dose, then take the second dose while sitting in bed, and turn off the alarm. If you have children or pets in the house, be sure to use the child-resistant caps that come with the medication cups.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor will gradually increase your dose over 1 to 2 weeks to lessen the risk of side effects. This process will continue until your doctor has found the right dose for you. Follow your doctor's directions carefully. Do not increase your dose, take it more frequently, or use it for longer than prescribed.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each night.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, psychosis, fast heartbeat, trouble sleeping) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Tell your doctor if your condition persists or worsens.
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