Ramelteon 8mg / Doxepin 3mg Tablet

What is Ramelteon / Doxepin Tablet??

Ramelteon 8 mg / Doxepin 3 mg Tablet is a compounded oral medication containing two medicines used to treat different features of insomnia. Ramelteon acts on melatonin receptors and is used to help with difficulty falling asleep. Low-dose doxepin blocks histamine receptors and is used to help with difficulty staying asleep.

Your prescribing provider may recommend this compounded combination when support for both sleep onset and sleep maintenance is appropriate. Although ramelteon and low-dose doxepin are individually FDA approved for insomnia, this compounded fixed-dose combination has not been approved or evaluated by the FDA. Individual results vary, and no specific clinical outcome is guaranteed.

Active ingredients: Ramelteon 8 mg and Doxepin 3 mg

Route: Oral (taken by mouth)

Dosage form: Compounded tablet

Strength: Ramelteon 8 mg / Doxepin 3 mg per tablet

Who Should NOT Use Ramelteon / Doxepin Tablet

Do not use this medication if any of the following apply to you:

• You have had an allergic or hypersensitivity reaction to ramelteon, doxepin, other dibenzoxepines, or any ingredient in the compounded tablet.
• You have previously developed swelling of the face, lips, tongue, or throat (angioedema) after taking ramelteon.
• You are taking fluvoxamine. Fluvoxamine can greatly increase ramelteon exposure and should not be used with this medication.
• You are taking a monoamine oxidase inhibitor (MAOI), or have taken an MAOI within the past 14 days.
• You have untreated narrow-angle glaucoma or severe urinary retention.

If you are unsure whether any of these apply to you, talk to your prescribing provider or pharmacist before using this medication.

Warnings and Precautions

Next-day impairment and sedation

This medication can cause drowsiness, dizziness, slowed thinking, or impaired coordination. Take it only when you can remain in bed for a full night. Do not drive, operate machinery, or perform hazardous activities until you know how the medication affects you.

Complex sleep behaviors

Sleepwalking, sleep-driving, preparing or eating food, making phone calls, or other activities while not fully awake have been reported with sleep medicines. Stop taking this medication and contact your provider immediately if this occurs.

Abnormal thinking or behavior changes

Sleepwalking, sleep-driving, preparing or eating food, making phone calls, or other activities while not fully awake have been reported with sleep medicines. Stop taking this medication and contact your provider immediately if this occurs.

Allergic reactions

Stop taking this medication and seek immediate medical attention if you develop swelling of the face, lips, tongue, or throat and difficulty breathing or wheezing.

Breathing problems and other conditions

Use caution and discuss with your provider if you have sleep apnea, chronic lung disease, depression, bipolar disorder, glaucoma, urinary retention, prostate problems, liver disease, or a history of substance use.

Endocrine and reproductive effects

Ramelteon may affect reproductive hormones. Tell your provider if you develop missed menstrual periods, unexpected breast milk production, decreased libido, or fertility concerns.

Do not exceed the prescribed dose. Taking more than prescribed may increase sedation and other serious adverse effects.

Possible Side Effects

Like all medications, Ramelteon / Doxepin Tablet can cause side effects. The list below is not complete. Contact your provider or pharmacist for medical advice about side effects.

Common side effects

• Daytime drowsiness or sleepiness
• Dizziness or lightheadedness
• Fatigue or tiredness
• Headache
• Nausea or upset stomach
• Dry mouth
• Vivid or unusual dreams
  

Less common or potentially serious side effects

• Complex sleep behaviors or memory loss for events occurring after the dose
• Worsening depression, suicidal thoughts, agitation, hallucinations, or unusual behavior
• Severe allergic reaction or angioedema: swelling of the face, lips, tongue, or throat; difficulty breathing; rash; or hives
• Fast, slow, or irregular heartbeat; fainting; or severe dizziness
• Blurred vision, eye pain, or seeing halos around lights
• Difficulty urinating or inability to urinate
• Unexpected breast milk production, missed menstrual periods, decreased libido, or fertility concerns
  

Seek emergency medical care immediately for difficulty breathing, swelling of the face or throat, fainting, severe confusion, or thoughts of self-harm.

Drug and Substance Interactions

Tell your provider and pharmacist about all medications, supplements, and substances you use. Important interactions may include:

• Fluvoxamine: do not use with this medication because it can greatly increase ramelteon exposure
• MAO inhibitors: do not use during treatment or within 14 days before or after use unless specifically directed by your provider
• Alcohol, cannabis, opioids, benzodiazepines, antihistamines, sleep aids, muscle relaxants, and other substances that cause sedation
• Cimetidine and other medicines that may increase doxepin or ramelteon levels
• Rifampin and other strong enzyme inducers, which may reduce ramelteon effectiveness
• Certain antidepressants, antipsychotics, antiarrhythmics, or other medicines that affect the central nervous system or heart rhythm
• Other melatonin products, sedatives, or prescription and over-the-counter sleep medications
  

Do not drink alcohol while taking this medication. Combining it with alcohol or other sedating substances may cause dangerous drowsiness, impaired judgment, falls, or breathing problems.

Special Populations

Pregnancy

Available human data are limited. Tell your provider if you are pregnant, planning pregnancy, or become pregnant while using this medication. Your provider will weigh the potential benefits and risks.

Breastfeeding

Ramelteon and doxepin may pass into breast milk. Doxepin has been associated with serious adverse effects in breastfed infants. Breastfeeding is generally not recommended during treatment unless your provider specifically determines otherwise.

Children and adolescents

The safety and effectiveness of this compounded combination have not been established in patients under 18 years of age. This product is not intended for pediatric use unless specifically prescribed by a qualified provider.

Older adults

Older adults may be more sensitive to sedation, confusion, dizziness, and falls. The doxepin 3 mg component is the usual recommended starting dose for older adults, but the combination should still be used cautiously.

Liver impairment

Ramelteon exposure may be increased in liver disease. This medication is not recommended in severe hepatic impairment and should be used cautiously in moderate hepatic impairment.

How to Use Ramelteon / Doxepin Tablet

Use this medication exactly as prescribed. Unless your pharmacy label states otherwise, take one tablet by mouth within 30 minutes of bedtime, only when you can remain in bed for a full night.

Step-by-step use

• Take the tablet with water and swallow it as directed by your pharmacy label.
• Take the dose within 30 minutes before going to bed.
• Do not take within 3 hours of a meal. Avoid taking it with or immediately after a high-fat meal because food may delay or alter the medication's effect.
• Do not take an additional dose during the same night.
• Do not combine with alcohol or other sleep medicines unless your provider has specifically instructed you to do so.
• Plan to remain in bed for a full night after taking the dose.

Step-by-step use

If you forget the dose at bedtime, skip it. Do not take it later in the night unless your provider has specifically instructed you and you can remain in bed for a full night. Do not double the next dose.

If you use too much

If you take more than prescribed, contact your provider or Poison Control at 1-800-222-1222. Seek emergency medical care for extreme sleepiness, confusion, difficulty breathing, fainting, seizure, abnormal heartbeat, or a serious allergic reaction.

Storage and Disposal

• Store at controlled room temperature as directed on your pharmacy label, generally 20-25 degrees C (68-77 degrees F), unless your pharmacy instructs otherwise.
• Protect from moisture, excessive heat, and direct light.
• Keep the container tightly closed and store the tablets in the original pharmacy-dispensed container.
• Do not store in a bathroom or other humid location.
• Do not use after the beyond-use date (BUD) printed on the pharmacy label.
• Do not use tablets that are damaged, discolored, have an unusual odor, or appear different from when dispensed.
• Keep out of reach of children and pets.
• Dispose of unused or expired medication according to your pharmacist's instructions or through an authorized medication take-back program. Do not flush unless specifically instructed.

Reporting Side Effects

If you experience any side effects, contact your prescribing provider or the dispensing pharmacy - The Pharmacy Hub, 1-888-958-1382. Serious or unexpected side effects may also be reported to the FDA MedWatch program:

• Phone: 1-800-FDA-1088 (1-800-332-1088)
• Online: www.fda.gov/medwatch