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Label Changes for:

Rozerem (ramelteon) Tablets

October 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings



  • Severe Anaphylactic/Anaphylactoid Reactions
  • Need to Evaluate for Co-morbid Dianoses
    • ...The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated...
  • Abnormal Thinking and Behavioral Changes
  • CNS Effects
    • ...Patients should be advised not to consume alcohol in combination with Rozerem as alcohol and Rozerem may have additive effects when used in conjunction.


  • Clinical Trials Experience
    • Adverse Reactions Resulting in Discontinuation of Treatment
    • Rozerem Most Commonly Observed Adverse Events
      • Table 1


  • Effect of Alcohol on Rozerem


  • Pregnancy
  • Nursing Mothers
    • ...caution should be exercised when administered to a nursing woman.
  • Geriatric Use
    • ...A double-blind, randomized, placebo-controlled study in elderly subjects with insomnia (n=33)...
  • Chronic Obstructive Pulmonary Disease
  • Sleep Apnea


  • Carcinogenesis
  • Mutagenesis
  • Impairment of Fertility


  • Severe Anaphylactic and Anaphylactoid Reactions
  • Sleep-driving and other Complex Behaviors
  • Endocrine Effects
  • Administration Instructions
    • ...Do not break the tablet; it should be swallowed whole.



Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug.

Patients should not take Rozerem in conjunction with fluvoxamine (Luvox) [see Drug Interaction (7)].


Severe Anaphylactic/Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of Rozerem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug.

Abnormal Thinking and Behavioral Changes

A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics. In primarily depressed patients, worsening of depression (including suicidal ideation and completed suicides) has been reported in association with the use of hypnotics.

Hallucinations, as well as behavioral changes such as bizarre behavior, agitation and mania have been reported with Rozerem use. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably.

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with hypnotic use. The use of alcohol and other CNS depressants may increase the risk of such behaviors. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Complex behaviors have been reported with the use of Rozerem. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.