Desyrel Dividose (Oral)

Trazodone is used to treat depression. It is believed to work by increasing the activity of serotonin in the brain. Trazodone is an antidepressant.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check how you are doing at regular visits. This helps adjust your dose and manage any side effects.

Do not take trazodone with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking trazodone within 2 weeks after stopping a MAO inhibitor, and wait 2 weeks after stopping trazodone before starting a MAO inhibitor. Taking them together or not waiting for 2 weeks may cause confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, extremely high blood pressure, or severe convulsions.

Trazodone may cause a serious condition called serotonin syndrome if taken with some other medicines. Do not use trazodone with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (for example, sumatriptan, tramadol, Frova®, Maxalt®, Relpax®, Zomig®).

For some teenagers and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself or others. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act recklessly. Also, tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of serious conditions called serotonin syndrome and neuroleptic malignant syndrome-like reactions. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Contact your doctor right away if you notice any changes in your heart rhythm, such as feeling dizzy or faint, or having a fast, pounding, or uneven heartbeat. These could be signs of a heart problem called QT prolongation.

Dizziness, lightheadedness, or fainting may happen, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually lower your dose before stopping it completely. This can help prevent your condition from worsening and reduce the chance of withdrawal symptoms such as anxiety, irritability, restlessness, or trouble sleeping.

This medicine may make some people drowsy or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds, sedatives, tranquilizers or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while using this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking trazodone with anesthetic medicines (numbing medicines) used during surgery, dental treatments, or emergency treatments may increase CNS depressant effects.

Trazodone may cause dry mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your doctor or dentist. Ongoing dryness of the mouth may increase the risk of dental disease, including tooth decay, gum disease, and fungal infections.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the risks of using the drug must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medications. As well inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trazodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of trazodone extended-release tablets in the elderly. Nevertheless, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution in patients receiving trazodone.

No guidance is available on the relationship of age to the effects of trazodone regular tablets in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks prior to using this medication while breastfeeding.

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially essential that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following drugs is not recommended. Your physician may decide not to treat you with this medication or change some of the other drugs you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Isocarboxazid
• Ketoconazole
• Levoketoconazole
• Linezolid
• Mesoridazine
• Methylene Blue
• Moclobemide
• Nelfinavir
• Nialamide
• Phenelzine
• Pimozide
• Piperaquine
• Posaconazole
• Procarbazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using this drug with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Abametapir
• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apixaban
• Apomorphine
• Ardeparin
• Argatroban
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azithromycin
• Baclofen
• Bedaquiline
• Bemiparin
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Boceprevir
• Bromazepam
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Buserelin
• Buspirone
• Butalbital
• Butorphanol
• Calcium Oxybate
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Celecoxib
• Ceritinib
• Certoparin
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Choline Salicylate
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clonixin
• Clopidogrel
• Clorazepate
• Clothiapine
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Dalteparin
• Danaparoid
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Desirudin
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diacetylmorphine
• Diazepam
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxylamine
• Droperidol
• Drotrecogin Alfa
• Droxicam
• Duloxetine
• Ebastine
• Edoxaban
• Efavirenz
• Eletriptan
• Encorafenib
• Enoxaparin
• Entrectinib
• Eptifibatide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Frovatriptan
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Ginkgo
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Heparin
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Indomethacin
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketazolam
• Ketobemidone
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Lepirudin
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lofepramine
• Lofexidine
• Lopinavir
• Lorazepam
• Lorcaserin
• Lornoxicam
• Loxapine
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methamphetamine
• Methocarbamol
• Methohexital
• Metronidazole
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadroparin
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nepafenac
• Netupitant
• Nicomorphine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Nitrazepam
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxazepam
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perphenazine
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Pipamperone
• Piritramide
• Piroxicam
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Pranoprofen
• Prasugrel
• Prazepam
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propofol
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranolazine
• Relugolix
• Remifentanil
• Reviparin
• Ribociclib
• Risperidone
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Secobarbital
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Tenoxicam
• Tetrabenazine
• Thiopental
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Tinzaparin
• Tirofiban
• Tizanidine
• Tolfenamic Acid
• Tolmetin
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Treprostinil
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Vorapaxar
• Voriconazole
• Vorinostat
• Vortioxetine
• Warfarin
• Zaleplon
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Digoxin
• Foxglove
• Phenytoin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical problems may affect the use of this drug. Make sure you inform your doctor if you have any other medical issues, especially:

• Behavior or mood changes (eg, aggression, panic attacks) or
• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Glaucoma (angle closure type) or
• Heart rhythm problems (eg, QT prolongation) or
• Hyponatremia (low sodium in the blood) or
• Hypotension (low blood pressure) or
• Mania or hypomania (mood disorders), history of or
• Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.

• Heart attack, recent—Use is not advised in patients with this condition.

• Heart disease or
• Heart rhythm issues (eg, QT prolongation), family history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become worse.

Along with its needed effects, a medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness
• sweating
• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion about identity, place, and time
• decreased concentration
• fainting
• general feeling of discomfort or illness
• headache
• lack of coordination
• muscle tremors
• nervousness
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• swelling

Rare

• Skin rash
• unusual excitement

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

• Dry mouth (usually mild)
• muscle or bone pain
• trouble sleeping
• trouble with remembering
• unpleasant taste

Less common

• Constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• diarrhea
• hearing loss
• muscle aches or pains
• weight loss

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Desyrel
• Desyrel Dividose
• Oleptro

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidepressant

Chemical Class: Triazolopyridine

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To lessen stomach upset and to reduce dizziness and lightheadedness, take the regular tablet with or shortly after a meal or light snack.

Take the extended-release tablet at the same time each day, preferably at bedtime, without food.

The tablet can be swallowed whole or given as a half tablet by breaking the tablet along the score line. Do not break the tablet unless your doctor tells you to. Do not crush or chew the tablet.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For depression: For oral dosage form (extended-release tablets): Adults—At first, 150 milligrams (mg) per day as a single dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 375 mg per day. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 150 milligrams (mg) per day, given in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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