Generic name: suvorexant
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics
What is Belsomra?
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.
Before taking this medicine
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);
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.
How should I take Belsomra?
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
-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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
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.
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;
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.
What other drugs will affect Belsomra?
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.
The Belsomra mechanism of action involves blocking the action of orexin, a chemical used in the sleep-wake cycle in the brain. The active ingredient in Belsomra is called suvorexant and it is classified as an orexin receptor antagonist. It was the first approved drug in this newer class of drugs used for insomnia. In clinical studies, people fell asleep faster and stayed asleep longer when using Belsomra compared to those taking placebo.
Weight loss is not listed as a side effect or a consequence of taking Belsomra and neither is weight gain. If you are taking Belsomra, then you should not expect your weight to change much at all. Weight loss with Belsomra was not reported in clinical studies but a small study that gave Belsomra to people with type 2 diabetes and insomnia did report a reduction in waist size, but weight loss was not significant.
If you do notice weight loss with Belsomra it may be the result of reducing your calorie intake because you are now sleeping through the night and not getting up for snacks.
Most adults who have trouble falling asleep or staying asleep can start with 10mg of Belsomra, once a night, within 30 minutes of going to bed. The Belsomra schedule can be increased to 15mg a night if it is well tolerated but not quite effective enough. The maximum dosage of Belsomra is 20mg a night, once a night.
For those also taking moderate CYP3A inhibitors such as amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, or fosamprenavir, the recommended Belsomra schedule is 5mg a night which may be increased to a maximum of 10mg per night. Belsomra should NOT be taken with strong CYP3A inhibitors such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir.
Belsomra should be taken no more than once per night and within 30 minutes of bed. There must be at least 7 hours remaining before the planned time of awakening.
It may take longer for Belsomra to start working if it is taken with or soon after a meal.
The use of Belsomra (suvorexant) with other drugs to treat insomnia (trouble sleeping) is not recommended. Ambien (zolpidem) is also a prescription drug used to treat insomnia. Taking these drugs together may increase the risk of side effects such as dizziness, drowsiness, confusion, and difficulty concentrating.
In clinical studies, Belsomra was given for up to 3 months to patients with insomnia (trouble sleeping), but only take Belsomra as long as your doctor recommends. Call your doctor if your insomnia worsens or is not better within 7 to 10 days.
The Belsomra (suvorexant) film-coated tablet is not scored and is not meant to be cut in half. Ask your healthcare professional before splitting any tablet. The manufacturer supplies the Belsomra tablet in 4 strengths: 5 mg, 10 mg, 15 mg and 20 mg. Your doctor can prescribe the strength that you need.
Research has shown that Belsomra is more effective than a placebo (an inactive tablet) for improving sleep onset (the time it takes to fall asleep) and how long people stay asleep. Results were based on both the person in the study’s subjective experience and a polysomnography (sleep study) result.
On average, people fell asleep up to 10 minutes quicker than they did with a placebo tablet, and stayed asleep for up to 31 minutes longer.
But people taking Belsomra were more likely to feel drowsy the next day compared with those who took a placebo, and some study participants were involved in driving accidents or got traffic tickets.
Belsomra does not treat anxiety, and is not approved by the FDA for anxiety, it is only approved to treat insomnia. One study that included 40 psychiatric inpatients from Kusatsu Hospital in Hiroshima, Japan reported that Belsomra improved sleep quality and did reduce the severity of anxiety, but more research is needed. Belsomra can cause anxiety in some people, or make pre-existing anxiety worse, with some people reporting major anxiety at night.
Yes, Belsomra is a Schedule IV controlled substance. 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. The Belsomra controlled substance is suvorexant, the generic name of the drug.
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