Effects of Ramelteon on Driving Ability

Inclusion criteria

• The subject is male or female, 21 - 55 years of age, inclusive
• The subject is capable of understanding and complying with the protocol requirements.
• The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
• The subject, if female, is non-pregnant and non-lactating.
• Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
• An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.

Exclusion criteria

• The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
• The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.

5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.