Belsomra

Belsomra (suvorexant) is used to treat insomnia, to help if you fall asleep faster and stay asleep longer, so you have have a better nights sleep. Belsomra works on orexin receptors which plays a role in wakefulness, and helps regulate your sleep and wake cycle. Belsomra is a dual orexin receptor antagonists (DORAs).

Belsomra is a controlled substance, Schedule IV. Schedule IV controlled substances have a low potential for drug abuse and low risk of dependence. But some patients with a history of abuse or addiction may still be at an increased risk of abuse.

Belsomra is a tablet that you take half an hour before you go to bed.

Take Belsomra exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Belsomra may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take Belsomra only once per night, 30 minutes before bedtime.

You may take Belsomra with or without food. Avoid taking the medicine shortly after eating a meal, or the medicine may take longer to work.

Belsomra will make you fall asleep. Never take this medicine if you do not have 7 hours to sleep before being active again.

You may have trouble speaking or moving while you are falling asleep. It may take longer for you to wake up, speak, or move around when you wake up. You may feel like you are still dreaming for several minutes after waking.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using Belsomra for 7 to 10 nights in a row.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not take more Belsomra than your doctor has prescribed.

You should not use Belsomra if you have narcolepsy.

Take Belsomra 30 minutes before bedtime. Never take this medicine if you do not have 7 hours to sleep before being active again.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

You should not use Belsomra if you are allergic to suvorexant, or if you have narcolepsy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or thoughts about suicide;
• drug or alcohol abuse or addiction;
• breathing problems, sleep apnea (breathing stops during sleep);
• liver disease;
• sudden muscle weakness;
• excessive sleepiness during normal waking hours; or
• if you have ever fallen asleep at unexpected times.

Tell your doctor if you are pregnant or breastfeeding. Belsomra passes into your breast milk.

Belsomra is not approved for use by anyone younger than 18 years old.

Common Belsomra side effects include strange dreams or drowsiness during the day after taking this medicine. Drowsiness can increase your risk of falling, especially if you are an older adult.

Serious Belsomra side effects

Get emergency medical help if you have signs of an allergic reaction to Belsomra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

• trouble moving or talking when you first wake up;
• a weak feeling in your legs;
• unusual thoughts or behavior;
• anxiety, agitation, depression;
• memory problems;
• confusion, hallucinations; or
• thoughts about hurting yourself.

You may be more likely to have side effects if you are overweight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Insomnia:

10 mg orally once a day at bedtime Maximum dose: 20 mg once a day Comments: -Take within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. -If 10 mg is well-tolerated but not effective, the dose can be increased. -Time to effect may be delayed if taken with or soon after a meal. Use: Insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Since Belsomra is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medicine if you do not have 7 hours to sleep before being active again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You may still feel drowsy the next day after taking Belsomra. Do not drive or do anything that requires you to be alert until you feel fully awake.

Avoid drinking alcohol. Do not take Belsomra if you have consumed alcohol within a few hours before getting ready for sleep.

Using Belsomra with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with suvorexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• Store at 20°C to 25°C (68°F to 77°F)
• Store in original package until use, to protect from light and moisture.

Active ingredient: Suvorexant

Inactive ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone).

The film coating contains: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.

Distributed by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA