Almorexant in Primary Insomnia

Inclusion Criteria

• •Men or women 18 - 65 years of age (inclusive).
• •Women of childbearing potential must have a negative urine pregnancy test at the screening visit, the screening adaptation night, and pre-treatment and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
• •Reliable methods of contraception are:
• •Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
• •Intra-uterine devices.
• •Oral, injectable, implantable or transdermal contraceptives only in combination with a barrier method.
• •* Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
• •Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
• •Body mass index (BMI) between 18 and 30 kg/m2 (limits included) at screening visit.
• •12-lead ECG without clinically relevant abnormalities at screening visit.
• •Hematology and biochemistry test results not deviating from the normal range to a clinically relevant extent at screening visit and following the screening/adaptation night.
• •Primary insomnia by DSM-IV-TR criteria based on medical history and the assessments performed at screening visit.
• •History of the following for at least 3 months prior to the screening visit:
• •* Usual reported subjective total sleep time (TST) 3 - 6 hours.
• •* Usual sleep disturbance with a subjective sleep onset latency of \> 30 min.
• •* Daytime complaints associated with poor sleep (e.g., fatigue, irritability, difficulty concentrating).
• •Polysomnography (PSG) at screening/adaptation night confirming TST \< 6 h and LPS ≥ 20 min.
• •Willingness to refrain from CNS-active drugs for 5 half-lives of the respective drug (but at least 1 week) prior to the screening/adaptation night and up to the end of treatment period 2. The usage of short-acting hypnotics (defined as hypnotics with a half-life of up to and including 10 hours) is allowed up to 48 hours prior to each PSG night, i.e., prior to the screening/adaptation night and prior to the treatment PSG nights.
• •Urine drug test negative for barbiturates, cannabinoids, amphetamines, and cocaine at screening visit 1, screening/adaptation PSG night and pre-treatment. Urine drug test negative for benzodiazepines and opiates at screening/adaptation PSG night and pre-treatment.
• •Signed informed consent prior to any study-mandated procedure.