Rozerem (Ramelteon) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Overview

The data described in this section reflect exposure to ROZEREM in 4251 subjects, including 346 exposed for 6 months or longer, and 473 subjects for one year.

Adverse Reactions Resulting in Discontinuation of Treatment

Six percent of the 3594 individual subjects exposed to ROZEREM in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 1370 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM were somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%).

ROZEREM Most Commonly Observed Adverse Events in Phase 1-3 trials

Table 1 displays the incidence of adverse events during the Phase 1 through 3 trials.

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 in Phase 1-3 Studies

MedDRA Preferred Term	Placebo (n=1370)	Ramelteon 8 mg (n=1250)
Headache NOS	7%	7%
Somnolence	3%	5%
Fatigue	2%	4%
Dizziness	3%	5%
Nausea	2%	3%
Insomnia exacerbated	2%	3%
Upper respiratory tract infection NOS	2%	3%
Diarrhea NOS	2%	2%
Myalgia	1%	2%
Depression	1%	2%
Dysgeusia	1%	2%
Arthralgia	1%	2%
Influenza	0	1%
Blood cortisol decreased	0	1%

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ROZEREM

Possible Rozerem side effects / adverse reactions in 46 year old male

Reported by a physician from United States on 2007-01-17

Patient: 46 year old male weighing 104.3 kg (229.5 pounds)

Reactions: Drug Ineffective, Somnolence

Suspect drug(s):
Benadryl (Sodium Citrate, Menthol, Diphenhydramine Hydrochloride, Ammo
    Dosage: per oral
    Administration route: Oral
    Indication: Sleep Disorder

Rozerem
    Dosage: per oral; 8 mg, qhs, per oral; 16 mg, qhs, per oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-10-31

Rozerem
    Dosage: per oral; 8 mg, qhs, per oral; 16 mg, qhs, per oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-11-01

Rozerem
    Dosage: per oral; 8 mg, qhs, per oral; 16 mg, qhs, per oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-11-02

Other drugs received by patient: Glucophage; Lisinopril; Zocor; Ambien CR (Zolpidem Tartrate)

Possible Rozerem side effects / adverse reactions in 59 year old female

Reported by a consumer/non-health professional from United States on 2007-01-19

Patient: 59 year old female weighing 38.6 kg (84.8 pounds)

Reactions: Migraine, Insomnia, Somnolence, Eye Pain

Suspect drug(s):
Rozerem
    Dosage: see image
    Administration route: Oral
    Indication: Insomnia
    End date: 2007-01-08

Rozerem
    Dosage: see image
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-12-01

Other drugs received by patient: Seroquel; Klonopin; Lithium Carbonate; Depakote; Imitrex; Vicodin

Possible Rozerem side effects / adverse reactions in 46 year old male

Reported by a consumer/non-health professional from United States on 2007-01-19

Patient: 46 year old male weighing 90.7 kg (199.6 pounds)

Reactions: Middle Insomnia, Drug Effect Decreased

Suspect drug(s):
Rozerem