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Rozerem Side Effects

Generic Name: ramelteon

Note: This page contains side effects data for the generic drug ramelteon. It is possible that some of the dosage forms included below may not apply to the brand name Rozerem.

It is possible that some side effects of Rozerem may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ramelteon: oral tablet

As well as its needed effects, ramelteon (the active ingredient contained in Rozerem) may cause unwanted side effects that require medical attention.

Some ramelteon side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Dizziness
  • sleepiness or unusual drowsiness
Less common
  • Body aches or pain
  • change in taste
  • chills
  • cough
  • difficulty in breathing
  • difficulty in moving
  • discouragement
  • ear congestion
  • fatigue
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • irritability
  • joint pain
  • loss of appetite
  • loss of interest or pleasure
  • loss of taste
  • loss of voice
  • muscle aching or cramping
  • muscle pain or stiffness
  • nasal congestion
  • nausea
  • pain in joints
  • runny nose
  • shivering
  • sleeplessness
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to ramelteon: oral tablet

Gastrointestinal

Gastrointestinal side effects for ramelteon (the active ingredient contained in Rozerem) in relation to placebo therapy have included nausea (3% vs. 2%), diarrhea (2% vs. 2%), and dysgeusia (2% vs. 1%).

Musculoskeletal

Musculoskeletal side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included myalgia (2% vs. 1%) and arthralgia (2% vs. 1%).

Nervous system

Nervous system side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included somnolence (5% vs. 3%), dizziness (5% vs. 3%), and exacerbated insomnia (3% vs. 2%).

Other

Other side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included headache (7% vs. 7%), fatigue (4% vs. 2%) and influenza (1% vs. 0%).

Psychiatric

Psychiatric side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included depression (2% vs. 1%). Hallucinations, as well as behavioral changes such as bizarre behavior, agitation, and mania have also been reported with ramelteon use.

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.

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. Complex behaviors have been reported with the use of ramelteon.

Discontinuation of ramelteon should be strongly considered for patients who report any complex sleep behavior.

Respiratory

Respiratory side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included upper respiratory tract infection (3% vs. 2%). Pharyngolaryngeal pain (1.9%) has also been reported.

Endocrine

Endocrine side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included decreased blood cortisol level (1% vs. 0%). Compared with placebo, increases in serum prolactin levels have been reported in patients receiving a 16 mg dose (19% vs 32%, respectively) of ramelteon.

General

In general, ramelteon (the active ingredient contained in Rozerem) has been well tolerated with most side effects described as mild or moderate in severity. In clinical trials, approximately 5% of patients discontinued treatment with ramelteon due to side effects. There have been no reports of cognitive impairment, rebound insomnia following discontinuation of ramelteon, withdrawal effects, or abuse.

Hypersensitivity

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 ramelteon (the active ingredient contained in Rozerem) should not be rechallenged with the drug.

Hypersensitivity side effects including rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of ramelteon. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

Oncologic

Oncologic side effects reported in animal studies have included dose related increases in the incidence of hepatic tumors (adenomas, carcinomas, hepatoblastomas) and an increased incidence of benign Leydig cell tumors of the testis. Ramelteon (the active ingredient contained in Rozerem) was also reported to be clastogenic in the in vitro chromosomal aberration assay of animal lung cells.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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