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Table of Contents

1. Ramelteon
2. Trazodone
3. Doxepin

Ramelteon

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

Ramelteon should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. You should not drive or operate machinery at night after taking Ramelteon. Until you know how you will react to Ramelteon, you should be careful in performing such activities during the day following taking Ramelteon. Before you take Ramelteon, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Ramelteon you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

What should I tell my healthcare provider before taking Ramelteon?

Before you take Ramelteon, tell your healthcare provider if you:

• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Ramelteon and other medicines may affect each other causing side effects. Ramelteon may affect the way other medicines work, and other medicines may affects how Ramelteon works. Especially tell your healthcare provider if you take: Luvox (fluvoxamine).

Who should not take Ramelteon?

You should not use Ramelteon if you are allergic to it, or if:

• You have severe liver disease; or
• You also take fluvoxamine.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Ramelteon for a condition for which it was not prescribed. Do not share Ramelteon with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Dosing In Adults

The recommended dose of Ramelteon is 8 mg taken within 30 minutes of going to bed. It is recommended that Ramelteon not be taken with or immediately after a high-fat meal. The total Ramelteon dose should not exceed 8 mg per day.

Dosing In The Elderly

The recommended starting dose of Ramelteon in elderly patients (≥ 65 years old) is 8 mg once daily.

Administration

Ramelteon should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Ramelteon should not be taken within 3 hours of a meal.

The total Ramelteon dose should not exceed 8 mg per day.

How should I take Ramelteon?

• Take Ramelteon exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Ramelteon to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Ramelteon within 30 minutes of bedtime. After taking Ramelteon, you should confine your activities to those necessary to prepare for bed.
• Do not take Ramelteon within 3 hours of a meal. Ramelteon may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Ramelteon unless you are able to get a full night of sleep before you must be active again.

Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much Ramelteon, call your doctor or get medical help right away.

What should I avoid while taking Ramelteon?

You should not drink alcohol while taking Ramelteon. Alcohol can increase your chances of getting serious side effects with Ramelteon. You should not drive, operate heavy machinery, or do other dangerous activities after Ramelteon. You may still feel drowsy the next day after taking Ramelteon. Do not drive or do other dangerous activities after taking Ramelteon until you feel fully awake.

What is the most important information I should know about Ramelteon?

The most common side effect of Ramelteon is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ramelteon. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Ramelteon?

Store Ramelteon between 68° and 77°F (20° to 25°C).

Keep Ramelteon in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.

Keep Ramelteon and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Trazodone

Read the Medication Guide that comes with trazodone hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if there is something you do not understand or you want to learn about trazodone hydrochloride tablets.

What is the most important information I should know about trazodone hydrochloride tablets?

Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:

• All risks and benefits of treatment with antidepressant medicines
• All treatment choices for depression or other serious mental illnesses

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Trouble sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking (mania)
• Other unusual changes in behavior or mood

4. Visual problems: eye pain changes in vision swelling or redness in or around the eye

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

5. What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of your medicines.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Trazodone hydrochloride tablets are not approved for use in children. Talk to your healthcare provider for more information

What are trazodone hydrochloride tablets?

Trazodone hydrochloride tablets are a prescription medicine used to treat major depressive disorder in adults.

What should I tell my healthcare provider before taking trazodone hydrochloride tablets?

Before you take trazodone hydrochloride tablets tell your healthcare provider if you:

• have heart problems, including QT prolongation or a family history of it
• have ever had a heart attack
• have bipolar disorder
• have liver or kidney problems
• have other serious medical conditions
• are pregnant or plan to become pregnant. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if trazodone hydrochloride tablets into your breast milk. You and your healthcare provider should decide if you will take trazodone hydrochloride or breastfeed.
• have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take trazodone hydrochloride tablets?

• Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.
• If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.
• Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
• Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet. If you take too much trazodone hydrochloride, call your doctor or go to the nearest emergency room right away.

What should I avoid while taking trazodone hydrochloride tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.

What are the possible side effects of trazodone hydrochloride tablets?

Trazodone hydrochloride tablets can cause serious side effects or death. See “What is the most important information I should know about trazodone hydrochloride tablets?”

Serious side effects include:

• Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, nausea, vomiting, diarrhea.
• Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).
• Irregular or fast heartbeat or faint (QT prolongation).
• Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing).
• Unusual bruising or bleeding.
• Erection lasting for more than 6 hours (priapism).
• Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.
• Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of trazodone hydrochloride tablets include:

• Sleepiness
• Dizziness
• Constipation
• Blurry vision

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of trazodone hydrochloride tablets. For more information, ask your healthcare provider or pharmacist .

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

Doxepin

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Doxepin should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. If you are on a monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the past two weeks, you should not take Doxepin. You should not take Doxepin if you have an eye problem called narrow angle glaucoma that is not being treated, if you have severe urinary retention, or if you are allergic to any of the ingredients in Doxepin. You should not drive or operate machinery at night after taking Doxepin. Until you know how you will react to Doxepin, you should be careful in performing such activities during the day following taking Doxepin. Before you take Doxepin, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Doxepin you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

It is not known if Doxepin is safe and effective in children.

What should I tell my healthcare provider before taking Doxepin?

Before you take Doxepin, tell your healthcare provider if you:

• See “Who should not take Doxepin?”
• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions
• Are pregnant or plan to become pregnant. It is not known if Doxepin will harm your unborn baby.
• Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Are breast-feeding or plan to breast-feed. Doxepin can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Doxepin.
• You should not breast-feed while taking Doxepin.
• Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Doxepin and other medicines may affect each other causing side effects. Doxepin may affect the way other medicines work, and other medicines may affects how Doxepin works. Especially tell your healthcare provider if you take:

• A monoamine oxidase inhibitor (MAOI).

Who should not take Doxepin?

You should not take Doxepin if you take:

• Cimetidine (Tagamet) or other medicines that can affect certain liver enzymes.
• Certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing.
• The diabetes medicine tolazamide.
• Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Doxepin for a condition for which it was not prescribed. Do not share Doxepin with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

SILENOR® is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

DOSAGE AND ADMINISTRATION

The dose of SILENOR® should be individualized.

Dosing In Adults

The recommended dose of SILENOR® for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

Dosing In The Elderly

The recommended starting dose of SILENOR® in elderly patients (≥ 65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

Administration

SILENOR® should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, SILENOR® should not be taken within 3 hours of a meal.

The total SILENOR® dose should not exceed 6 mg per day.

How should I take Doxepin?

• Take Doxepin exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many Doxepin to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Doxepin within 30 minutes of bedtime. After taking Doxepin, you should confine your activities to those necessary to prepare for bed.
• Do not take Doxepin within 3 hours of a meal. Doxepin may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Doxepin unless you are able to get a full night of sleep before you must be active again.
• Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much Doxepin, call your healthcare provider or get medical help right away.

What should I avoid while taking Doxepin?

• You should not drink alcohol while taking Doxepin. Alcohol can increase your chances of getting serious side effects with Doxepin.
• You should not drive, operate heavy machinery, or do other dangerous activities after Doxepin.
• You may still feel drowsy the next day after taking Doxepin. Do not drive or do other dangerous activities after taking Doxepin until you feel fully awake.

What is the most important information I should know about Doxepin?

• The most common side effect of Doxepin is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Doxepin. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Doxepin?

• Store Doxepin between 68° and 77°F (20° to 25°C).
• Keep Doxepin in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.
• Keep Doxepin and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.