Clinical trial NCT00247390 (phase 3, status: completed)
Conditions: chronic insomnia
ICD codes: F51.01, F51.02, F51.03, F51.04, G47.00, G47.09, A81.83
Drugs: ramelteon, placebo
SMILES: CCC(=O)NCC[C@@H]1CCC2=C1C1=C(OCC1)C=C2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  Body mass index between 18 and 34, inclusive.

          -  Based on sleep history, has had chronic insomnia for at least 3 months.

          -  Based on sleep history, reports a subjective sleep latency greater than or equal to 45
             min and a subjective total sleep time less than or equal to 6.5 hours.

          -  Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.

          -  Mean latency to persistent sleep of greater than 20 minutes on two consecutive
             screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes
             of wake time during the 480 minutes in bed across two nights with no night less than
             45 minutes.

          -  Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times
             per week in the last 3 months.

        Exclusion Criteria

          -  Known hypersensitivity to ramelteon or related compounds, including melatonin, and
             melatonin related compounds.

          -  Participated in any other investigational study and/or taken any investigational drug
             within 30 days or five half-lives prior to the first dose of single-blind study
             medication, whichever is longer.

          -  Sleep schedule changes required by employment (eg, shift worker) within three months
             prior to the administration of single-blind study medication.

          -  Flown across greater than three time zones within 7 days prior to or during screening.

          -  Participated in a weight loss program or has substantially altered their exercise
             routine within 30 days prior to the administration of single-blind study medication.

          -  Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg
             movement syndrome, chronic obstructive pulmonary disease or fibromyalgia.

          -  History of psychiatric disorder within the past 6 months.

          -  History of alcohol abuse within the past 12 months, as defined in Diagnostic &
             Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes
             more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24
             hours of any polysomnogram visits.

          -  History of drug abuse within the past 12 months, as defined in Diagnostic &
             Statistical Manual of Mental Disorders, 4th Edition Revised.

          -  Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal,
             pulmonary, hematologic, neurological, or metabolic disease, unless currently
             controlled and stable with protocol-allowed medication, within 30 days prior to the
             first night of single-blind study medication.

          -  Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first
             polysomnogram screening night.

          -  Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10
             as seen on the first polysomnogram screening night.

          -  Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment
             visits.

          -  Positive breathalyzer test on any of the polysomnogram assessment visits.

          -  Uses tobacco products (including nicotine gum and patch) or any other products that
             may interfere with the sleep wake cycle during nightly awakenings.

          -  Used any central nervous system medication or other drugs or supplements known to
             affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is
             longer) prior to the administration of single-blind study medication. These
             medications must not have been used to treat psychiatric disorders.

          -  Intends to continue taking any disallowed medication or any prescription medication or
             over the counter medication that is known to affect the sleep/wake function or
             otherwise interfere with evaluation of the study medication. The subject must report
             all prescription and over the counter medications taken in the three weeks prior to
             screening.

          -  Is required to take or continues taking any disallowed medication, prescription
             medication, herbal treatment or over-the counter medication that may interfere with
             evaluation of the study medication, including:

               -  Anxiolytics

               -  Sedatives

               -  Hypnotics

               -  CNS active drugs (including herbal)

               -  Antidepressants

               -  Narcotic analgesics

               -  Anticonvulsants

               -  Beta blockers

               -  Sedating H1 antihistamines

               -  St. John's Wort

               -  Systemic steroids

               -  Kava-kava

               -  Respiratory stimulants

               -  Ginkgo-biloba

               -  Decongestants

               -  Over-the-counter and prescription stimulants

               -  Antipsychotics

               -  Over-the-counter and prescription diet aids

               -  Muscle Relaxants

               -  Melatonin and all other drugs or supplements known to affect sleep/wake function

          -  Any additional condition(s) that in the Investigator's opinion would

               -  affect sleep/wake function

               -  prohibit the subject from completing the study

               -  indicate that continuation in the study would not be in the best interests of the
                  subject.

          -  History of hepatitis B or hepatitis C.