Rozerem

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/16/2021
Rozerem Side Effects Center

What Is Rozerem?

Rozerem (ramelteon) is a hypnotic type sedative used to treat insomnia that is associated with having trouble falling asleep. Unlike some other sleep medications, Rozerem is not known to be habit-forming.

What Are Side Effects of Rozerem?

Common side effects of Rozerem include:

  • dizziness,
  • tiredness,
  • daytime drowsiness,
  • nausea, or
  • worsening sleep problems.

Tell your doctor if you have unlikely but serious side effects of Rozerem including:

  • decreased sexual desire,
  • missed menstrual periods,
  • nipple discharge, or
  • difficulty becoming pregnant.

Dosage for Rozerem

The recommended dose of Rozerem is 8 mg taken within 30 minutes of going to bed.

What Drugs, Substances, or Supplements Interact with Rozerem?

Rozerem may interact with primaquine, thabendazole, rifampin, antibiotics, heart rhythm medications, or antifungal medications. Tell your doctor all medications you are taking.

Rozerem During Pregnancy or Breastfeeding

Rozerem should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Additional Information

Our Rozerem (ramelteon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

What is insomnia? See Answer
Rozerem Consumer Information

2 pharmacies near 20147 have coupons for Rozerem (Brand Names:Rozerem for 8MG)

Walmart Pharmacy
Walmart Pharmacy
$299.19

Est. Regular Price

$49.38

with free coupon

View Coupon
Harris Teeter Pharmacy
Harris Teeter Pharmacy
$299.19

Est. Regular Price

$53.25

with free coupon

View Coupon

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; 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:

  • unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
  • a missed menstrual period;
  • nipple discharge; or
  • loss of interest in sex.

Common side effects may include:

  • drowsiness, tired feeling;
  • dizziness;
  • nausea; or
  • worsening sleep problems.

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.

Read the entire detailed patient monograph for Rozerem (Ramelteon)

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow
Rozerem Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections:

  • Severe anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
  • CNS effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Adverse Reactions Resulting In Discontinuation Of Treatment

The data described in this section reflect exposure to ROZEREM in 5373 subjects, including 722 exposed for six months or longer, and 448 subjects for one year.

Six percent of the 5373 individual subjects exposed to ROZEREM in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.

ROZEREM Most Commonly Observed Adverse Events

Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of ROZEREM.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Table 1: Incidence (% of subjects) of Treatment-Emergent Adverse Events

MedDRA Preferred Term Placebo
(n=1456)
Ramelteon 8 mg
(n=1405)
Somnolence 2% 3%
Fatigue 2% 3%
Dizziness 3% 4%
Nausea 2% 3%
Insomnia exacerbated 2% 3%

DRUG INTERACTIONS

Effects Of Other Drugs On ROZEREM

Fluvoxamine (strong CYP1A2 inhibitor)

AUC0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70-fold upon coadministration of fluvoxamine and ROZEREM, compared to ROZEREM administered alone. ROZEREM should not be used in combination with fluvoxamine [see CONTRAINDICATIONS, CLINICAL PHARMACOLOGY]. Other less strong CYP1A2 inhibitors have not been adequately studied. ROZEREM should be administered with caution to patients taking less strong CYP1A2 inhibitors.

Rifampin (strong CYP enzyme inducer)

Administration of multiple doses of rifampin resulted in a mean decrease of approximately 80% in total exposure to ramelteon and metabolite M-II. Efficacy may be reduced when ROZEREM is used in combination with strong CYP enzyme inducers such as rifampin [see CLINICAL PHARMACOLOGY].

Ketoconazole (strong CYP3A4 inhibitor)

The AUC0-inf and Cmax of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ROZEREM. ROZEREM should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see CLINICAL PHARMACOLOGY].

Fluconazole (strong CYP2C9 inhibitor)

The AUC0-inf and Cmax of ramelteon was increased by approximately 150% when ROZEREM was coadministered with fluconazole. ROZEREM should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole [see CLINICAL PHARMACOLOGY].

Donepezil

The AUC0-inf and Cmax of ramelteon increased by approximately 100% and 87%, respectively upon coadministration of donepezil with ROZEREM. Patients should be closely monitored when ROZEREM is coadministered with donepezil [see CLINICAL PHARMACOLOGY].

Doxepin

The AUC0-inf and Cmax of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin with ROZEREM. Patients should be closely monitored when ROZEREM is coadministered with doxepin [see CLINICAL PHARMACOLOGY].

Effect Of Alcohol On ROZEREM

Alcohol by itself impairs performance and can cause sleepiness. Since the intended effect of ROZEREM is to promote sleep, patients should be cautioned not to consume alcohol when using ROZEREM [see CLINICAL PHARMACOLOGY]. Use of the products in combination may have an additive effect.

Drug/Laboratory Test Interactions

ROZEREM is not known to interfere with commonly used clinical laboratory tests. In addition, in vitro data indicate that ramelteon does not cause false-positive results for benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screening methods in vitro.

Drug Abuse And Dependence

ROZEREM is not a controlled substance.

Discontinuation of ramelteon in animals or in humans after chronic administration did not produce withdrawal signs. Ramelteon does not appear to produce physical dependence.

Human Data

A laboratory abuse potential study was performed with ROZEREM [see Clinical Studies].

Animal Data

Ramelteon did not produce any signals from animal behavioral studies indicating that the drug produces rewarding effects. Monkeys did not self-administer ramelteon and the drug did not induce a conditioned place preference in rats. There was no generalization between ramelteon and midazolam. Ramelteon did not affect rotorod performance, an indicator of disruption of motor function, and it did not potentiate the ability of diazepam to interfere with rotorod performance.

Read the entire FDA prescribing information for Rozerem (Ramelteon)

© Rozerem Patient Information is supplied by Cerner Multum, Inc. and Rozerem Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors