Clinical trial NCT00308503 (phase 3, status: completed)
Conditions: sleep initiation and maintenance disorders, insomnia
ICD codes: Y93.E9, Y93.H9, F51.01, F51.02, F51.03, F51.04, G47.00, G47.09, A81.83
Drugs: eplivanserin (sr46349), placebo
SMILES: CN(C)CCO\N=C(\C=C\C1=CC=C(O)C=C1)/C1=CC=CC=C1F, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month
             preceding the study visit.

          -  Disturbance of sleep maintenance:

               -  Based on patient' s information:

                    -  Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed,
                       each night, over the preceding two weeks,

                    -  Patient must complain of at least one hour of wakefulness after sleep onset
                       for at least 3 nights per week over the preceding month,

                    -  Patient must report impact on daytime functioning associated with sleep
                       maintenance insomnia

        Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the
        sleep laboratory during the two screening nights.

        Exclusion Criteria:

          -  Females who are lactating or who are pregnant, or of childbearing potential not using
             an acceptable form of contraception

          -  Patients presenting with acute or chronic pain resulting in insomnia

          -  Patients with current psychiatric disturbances

          -  Body mass index > 32

          -  Evidence of any clinically significant, severe or unstable, acute or chronically
             progressive medical or surgical disorder, or any condition that may interfere with the
             absorption, metabolism, distribution or excretion of the study drug, or may affect
             patient safety

          -  Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms),

          -  A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C
             virus [HCV] antibodies)

          -  Positive qualitative urine drug screen at screening

          -  Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising
             usually more than 5 cups or glasses per day

          -  Use of any over-the-counter or prescription sleep medication, or of any substance with
             psychotropic effects or properties known to affect sleep/wake, within one week or five
             half-lives (whichever is longer), prior to screening

          -  Night shift workers, and individuals who nap 3 or more times per week over the
             preceding month

          -  Based on medical history and/or NPSG:

               -  primary hypersomnia

               -  narcolepsy

               -  breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep)

               -  circadian rhythm sleep disorder

               -  parasomnia (e.g. somnambulism)