Belsomra is a sleep medicine that helps regulate your sleep and wake cycle.

Belsomra is used to treat insomnia (trouble falling asleep or staying asleep).

Belsomra may also be used for purposes not listed in this medication guide.

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.

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.

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.

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

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.

For at least 8 hours after taking Belsomra, do not drive or do anything that requires you to be alert. Your reactions may be impaired.

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

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.

Common Belsomra side effects include:

• strange dreams; or

• drowsiness during the day after taking this medicine.

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.

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.