Generic Name: suvorexant
Date of Approval: August 13, 2014
Company: Merck Sharp & Dohme Corp.
Treatment for: Insomnia
FDA Approves Belsomra
The U.S. Food and Drug Administration (FDA) has approved the long-awaited Belsomra (suvorexant) tablets for difficulty in falling and staying asleep (insomnia). Belsomra, an orexin receptor antagonist, is the first approved drug in this new class. Belsomra blocks the action of orexin, a chemical involved in the sleep-wake cycle in the brain. The FDA has approved Belsomra in 5, 10, 15, and 20 milligram (mg) strengths. Belsomra is taken within 30 minutes of bed and no more than once per night with a max daily dose of 20 mg. After taking, at least seven hours should remain for uninterrupted sleep. Belsomra is expected to be available in pharmacies in late 2014 or early 2015.
Belsomra Medication Guide
Read the Medication Guide that comes with your prescription before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information about Belsomra
- Do not exceed recommended dose.
- Do not take this medicine unless you are able to stay in bed a full night (at least 7 hours) before you must be active again.
- Take tablets within 30 minutes of going to bed.
Belsomra may cause serious side effects that you may not know are happening to you. These side effects include:
- sleepiness during the day
- not thinking clearly
- act strangely, confused, or upset
- "sleep-walking" or doing other activities when you are asleep like eating, talking, having sex, or driving a car.
- Call your doctor right away if you find out that you have done any of the above activities.
What is Belsomra?
- Belsomra is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).
- It is not known if it is safe and effective in children under the age of 18.
Belsomra is a federally controlled substance because it can be abused or cause dependence. Keep tablets in a safe place to prevent misuse and abuse. Selling or giving away your tablets may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.
Who should not take Belsomra?
Do not take this medicine if you fall asleep often at unexpected times (narcolepsy).
Before taking Belsomra
Before taking this medicine, tell your doctor about all of your medical conditions, including if you:
- have a history of depression, mental illness, or suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have a history of a sudden onset of muscle weakness (cataplexy)
- have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness
- have lung problems or breathing problems
- have liver problems
- are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take this medicine with other medicines that can make you sleepy unless your doctor tells you to.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take Belsomra?
- Take this medicine exactly as your doctor tells you to take it.
- Only take it one time each night, if needed, within 30 minutes of going to bed.
- Only take it when you can get a full night’s sleep (at least 7 hours).
- Do not take this medicine if you drank alcohol that evening or before bed.
- Tablets may be taken with or without a meal. However, the drug may take longer to work if you take it with or right after meals.
- Call your doctor if your insomnia (sleep problem) worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
- If you take too much, call your doctor right away or get emergency treatment.
What should I avoid while taking Belsomra?
- Do not drink alcohol while taking this medicine. It can increase your chances of getting serious side effects.
- Do not drive, operate heavy machinery, do anything dangerous or do other activities that require clear thinking after taking Belsomra.
- You may still feel drowsy the next day after taking this medicine. Do not drive or do other dangerous activities until you feel fully awake.
Belsomra side effects
Belsomra may cause serious side effects including:
- See Important about Belsomra
- abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression and suicidal thoughts or actions.
- memory loss
- temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up.
- temporary weakness in your legs that can happen during the day or at night.
The most common side effects of include drowsiness the next day after you take Belsomra.
These are not all the possible side effects. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Belsomra?
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in the original package until use, to protect from light and moisture.
- Keep all medicines out of reach of children.
General information about the safe and effective use of Belsomra.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give this medicine to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients?
Active ingredient: Suvorexant
Inactive ingredients: Polyvinylpyrrolidone/vinyl acetate copolymer (copovidone), microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating contains: lactose monohydrate, hypromellose, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide yellow and iron oxide black, and the film coating for the 10 mg tablets also contains iron oxide yellow and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.