Belsomra information

What is Belsomra?

Belsomra (suvorexant) 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.

Important information

You should not use Belsomra if you have narcolepsy.

Before taking this medicine

You should not use Belsomra if you are allergic to suvorexant, or if you have narcolepsy.
Belsomra may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
To make sure Belsomra is safe for you, tell your doctor if you have:

• a history of depression or thoughts about suicide;
  
• sleep apnea (breathing stops during sleep); or
  
• chronic obstructive pulmonary disease (COPD) or other breathing disorder.
  

It is not known whether suvorexant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether suvorexant passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
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 all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Never use this medicine in larger amounts, or for longer than prescribed.
Belsomra should be taken only once per night. Take this medicine at bedtime or within 30 minutes before you go to bed.
Belsomra will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 hours to dedicate to sleeping.
Avoid taking Belsomra shortly after eating a meal. The medicine may not work as well during this time.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens, stop taking Belsomra and talk with your doctor about another treatment for your sleep disorder.
It may take longer for you to wake up, speak, or move around the morning after taking this medicine. You may have hallucinations or feel like you are still dreaming for a several minutes after you wake up.
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 the amount of medicine used from each new bottle. Belsomra is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Belsomra dosing information

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.
See also: Dosage Information (in more detail)

What happens if I miss a dose?

Since Belsomra is taken only at bedtime, you will not be on a frequent dosing schedule.

What happens if I overdose?

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

What should I avoid while taking Belsomra?

Do not drive or do anything that requires you to be alert if it has been less than 8 hours since you took Belsomra.
Belsomra can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Until you know how this medicine will affect you during waking hours, be careful if you drive, operate machinery or do anything that requires you to be awake and alert.
Do not drink alcohol while you are taking suvorexant. Alcohol can increase some of the side effects of this medicine, including drowsiness.
Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).
Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Belsomra side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Belsomra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Belsomra and call your doctor at once if you have:

• unusual thoughts or behavior;
  
• hallucinations; or
  
• thoughts about hurting yourself.
  

You may be more likely to have side effects if you are overweight.
Common Belsomra side effects may include:

• daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
  
• amnesia or forgetfulness;
  
• a weak feeling in your legs; or
  
• strange dreams.
  

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.
See also: Side effects (in more detail)

What other drugs will affect Belsomra?

Taking Belsomra with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Belsomra, especially:

• digoxin;
  
• imatinib;
  
• nefazodone;
  
• St. John's wort;
  
• verapamil;
  
• an antibiotic - ciprofloxacin, clarithromycin, rifampin, telithromycin;
  
• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;
  
• hepatitis C medications - boceprevir, telaprevir;
  
• HIV/AIDS medication - atazanavir, cobicistat (Evotaz, Prezcobix, Stribild, Tybost), delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir; or
  
• seizure medication - carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone.
  

This list is not complete. Other drugs may interact with suvorexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In Summary

Common side effects of Belsomra include: drowsiness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to suvorexant: oral tablet
In addition to its needed effects, some unwanted effects may be caused by suvorexant (the active ingredient contained in Belsomra). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking suvorexant:
More common:

• Sleepiness or unusual drowsiness

Less common:

• Unusual or abnormal dreams

Incidence not known:

• Changes in behavior
• discouragement
• fear or nervousness
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of memory
• problems with memory
• seeing, hearing, or feeling things that are not there
• temporary inability to move or talk for up to several minutes while you are going to sleep or wake up
• temporary weakness in your legs
• thoughts of killing oneself
• tiredness
• trouble concentrating

Minor Side Effects

Some of the side effects that can occur with suvorexant may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:

• Headache

Less common:

• Body aches or pain
• chills
• cough
• diarrhea
• difficulty with breathing
• dizziness
• dry mouth
• ear congestion
• fever
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

For Healthcare Professionals

Applies to suvorexant: oral tablet

General

The most common adverse reaction was somnolence.^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth^[Ref]

Nervous system

Common (1% to 10%): Headache, somnolence, dizziness^[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams^[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory tract infection^[Ref]

Effects and Side Effects Tramadol

In Summary

Commonly reported side effects of tramadol include: pruritus, agitation, anxiety, constipation, diarrhea, hallucination, nausea, tremor, vomiting, and diaphoresis. Other side effects include: insomnia, pruritus, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet disintegrating, oral tablet extended release
As well as its needed effects, tramadol may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking tramadol, check with your doctor immediately:
Less common or rare:

• Abdominal or stomach fullness
• abnormal or decreased touch sensation
• blisters under the skin
• bloating
• blood in the urine
• blood pressure increased
• blurred vision
• change in walking and balance
• chest pain or discomfort
• chills
• convulsions (seizures)
• darkened urine
• difficult urination
• dizziness or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• frequent urge to urinate
• gaseous abdominal or stomach pain
• heart rate increased
• indigestion
• irregular heartbeat
• loss of memory
• numbness and tingling of the face, fingers, or toes
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale bluish-colored or cold hands or feet
• recurrent fever
• seeing, hearing, or feeling things that are not there
• severe cramping
• severe nausea
• severe redness, swelling, and itching of the skin
• shortness of breath
• sweats
• trembling and shaking of the hands or feet
• trouble performing routine tasks
• weak or absent pulses in the legs
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking tramadol, get emergency help immediately:
Symptoms of overdose:

• Change in consciousness
• decreased awareness or responsiveness
• difficulty with breathing
• lack of muscle tone
• lightheadedness
• loss of consciousness
• pinpointed pupils of the eyes
• severe sleepiness
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Minor Side Effects

Some tramadol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:

• Abdominal or stomach pain
• agitation
• anxiety
• constipation
• cough
• diarrhea
• discouragement
• drowsiness
• dry mouth
• feeling of warmth
• feeling sad or empty
• feeling unusually cold
• fever
• general feeling of discomfort or illness
• headache
• heartburn
• irritability
• itching of the skin
• joint pain
• loss of appetite
• loss of interest or pleasure
• loss of strength or weakness
• muscle aches and pains
• nausea
• nervousness
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• runny nose
• shivering
• skin rash
• sleepiness or unusual drowsiness
• sore throat
• stuffy nose
• sweating
• tiredness
• trouble concentrating
• unusual feeling of excitement
• weakness

Less common or rare:

• Abnormal dreams
• appetite decreased
• back pain
• bladder pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• body aches or pain
• change in hearing
• clamminess
• cold flu-like symptoms
• confusion
• cough producing mucus
• cracked, dry, or scaly skin
• decreased interest in sexual intercourse
• difficult, burning, or painful urination
• difficulty with moving
• disturbance in attention
• ear congestion
• ear drainage
• earache or pain in ear
• excessive gas
• fall
• false or unusual sense of well-being
• feeling hot
• feeling jittery
• flushing or redness of the skin
• general feeling of bodily discomfort
• goosebumps
• headache, severe and throbbing
• hoarseness
• hot flashes
• inability to have or keep an erection
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• joint sprain
• joint stiffness
• joint swelling
• loss in sexual ability, desire, drive, or performance
• loss of voice
• lower back or side pain
• muscle aching or cramping
• muscle injury
• muscle pain or stiffness
• muscle spasms or twitching
• nasal congestion
• neck pain
• night sweats
• pain
• pain in the limbs
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• skin discoloration
• swelling
• swelling of the hands, ankles, feet, or lower legs
• tightness of the chest
• trouble in holding or releasing urine
• trouble with sleeping
• troubled breathing
• weight increased or decreased

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

• Gooseflesh
• high blood pressure
• increased sweating
• increased yawning
• shivering or trembling
• unusually large pupils

For Healthcare Professionals

Applies to tramadol: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release

General

The most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.^[Ref]

Psychiatric

CNS stimulation has been reported as a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).^[Ref]
Very common (10% or more): CNS stimulation (up to 14%)
Common (1% to 10%): Anxiety, euphoria, nervousness, sleep disorder, insomnia, depression, agitation, apathy, depersonalization
Uncommon (0.1% to 1%): Emotional lability
Rare (less than 0.1%): Hallucinations, nightmares, dependency
Very rare (less than 0.01%): Withdrawal syndrome^[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 40%), constipation (up to 46%), vomiting (up to 17%), dyspepsia (up to 13%)
Common (1% to 10%): Dry mouth, diarrhea, abdominal pain, flatulence, sore throat, gastroenteritis viral
Uncommon (0.1% to 1%): Toothache, appendicitis, pancreatitis^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 28%), somnolence (up to 25%), headache (up to 32%),
Common (1% to 10%): Confusion, coordination disturbance, tremor, paresthesia, hypoesthesia
Uncommon (0.1% to 1%): Migraine, sedation, syncope, disturbance in attention
Rare (less than 0.1%): Epileptiform seizures
Postmarketing reports: Seizures^[Ref]
Epileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.^[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 11%)
Common (1% to 10%): Sweating, rash, dermatitis
Uncommon (0.1% to 1%): Cellulitis, piloerection, clamminess, urticaria, toxic epidermal necrolysis, Stevens Johnson-syndrome, hair disorder, skin disorder^[Ref]

Genitourinary

Common (1% to 10%): Menopausal symptoms, urinary frequency, urinary retention, urinary tract infection
Uncommon (0.1% to 1%): Difficulty in micturition, hematuria, dysuria, cystitis, sexual function abnormality^[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 15.8%)
Common (1% to 10%): Vasodilation, postural hypotension, chest pain
Uncommon (0.1% to 1%): Palpitations, myocardial infarction, lower limb edema, peripheral swelling, hypertension, increased heart rate, peripheral ischemia, EKG abnormality, hypotension, tachycardia
Rare (less than 0.1%): Bradycardia^[Ref]

Other

Very common (10% or more): Asthenia (up to 12%)
Common (1% to 10%): Malaise, weakness, pain, feeling hot, influenza like illness, rigors, lethargy, pyrexia
Uncommon (0.1% to 1%): Tinnitus, vertigo, ear infection^[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased weight, increased blood glucose
Uncommon (0.1% to 1%): Gout
Rare (less than 0.1%): Changes in appetite^[Ref]

Endocrine

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis^[Ref]

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests^[Ref]

Ocular

Common (1% to 10%): Miosis, visual disturbance, blurred vision
Uncommon (0.1% to 1%): Lacrimation disorder
Frequency not reported: Mydriasis

Renal

Uncommon (0.1% to 1%): blood urea nitrogen increased