Belsomra

Generic name: Suvorexant
Dosage form: tablets (5 mg, 10 mg, 15 mg, 20 mg)
Drug class: Miscellaneous anxiolytics , Antineoplastic Agents

Usage of 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.

Belsomra side effects

Common Belsomra side effects include strange dreams or drowsiness during the day after taking this medicine.

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.

    Before taking Belsomra

    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.

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    How to use Belsomra

    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.

    Warnings

    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.

    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.

    Popular FAQ

    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.

    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.

    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.

    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.

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