Primary insomnia MedDRA version: 8.1 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: Sublinox 10 mg
Product Code: OX22
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: zolpidem
CAS Number: 82626-48-0
Other descriptive name: N, N-6-trimethyl(methyl-4 phenyl)-2
Sponsors
Orexo AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined based on the following selection criteria: 1. The subject is a male or female aged from18 to 65 years old, inclusive. 2. The subject, if female, is non-pregnant and non-lactating. Females of childbearing potential must use appropriate birth control (barrier methods, hormonal contraceptives, and/or intrauterine devices) for the entire duration of the study. 3. The subject is capable of understanding and willing to comply with the protocol and has signed the informed consent document at screening prior to any study related procedures being performed. 4. Based on sleep history, the subject fulfilled DSM-IV criteria for primary insomnia and had to present the following symptoms: - A complaint is difficulty initiating or maintaining sleep or of nonrestorative sleep that lasts for at least 3 months. - The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning. - The disturbance does not occur exclusively during the course of Narcolepsy, Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder or Parasomnia. - The subject’s sleep disturbance does not occur exclusively during the course of another mental disorder (eg, Major Depressive Disorder, Generalised Anxiety Disorder, a delirium). - The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition. 5. On two consecutive screening nights the subject has a TST 30 min and a LPS of >= 20 minutes with a mean LPS greater than 30 min. No LPS 30 min. 6. The subject’s habitual bedtime is between 10:00 p.m. and 1:00 a.m. 7. The subject has a body mass index (BMI) between 18 and 30, inclusive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: 1. The subject has a known hypersensitivity to zolpidem or related compounds. 2. The subject has participated in any other investigational study and/or taken any investigational drug within 30 days (or five half-lives of the drug prior to screening, whichever is longer) prior to screening. 3. The subject has sleep schedule changes required by employment (eg, shift worker) within three months prior to screening, or has flown across greater than three time zones within seven days prior to screening. 4. The subject has ever had a history of seizures; sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, periodic leg movement syndrome, schizophrenia, bipolar disorder, mental retardation, cognitive disorder or fibromyalgia. 5. The subject has a history of psychiatric disorder (including anxiety and depression) within the past 6 months. 6. The subject has a history of alcohol abuse or drug abuse within the past 12 months. 7. The subject has a current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to screening. 8. The subject has used drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to screening. 9. The subject has used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to screening. 10. The subject has any clinically important abnormal finding as determined by a medical history, physical examination, ECG, or clinical laboratory tests, as determined by the investigator. 11. The subject has a positive urine drug screen including alcohol at screening or at check-in. 12. The subject (only woman) has a positive pregnancy test (serum hCG) at screening or at check-in. 13. The subject has an apnoea hypopnoea index (per hour of sleep) >10 as seen on PSG, on the first night of the PSG screening. 14. The subject has periodic leg movement (PLM) with arousal index (per hour of sleep) >10 as seen on PSG, on the first night of PSG screening. 15. The subject has any additional condition(s) that in the Investigator’s opinion would: a) affect sleep/wake function, b) prohibit the subject from completing the study, or c) not be in the best interest of the subject. 16. Alcohol consumption > 40 g alcohol/day (1 glass (25 cl) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cl) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cl) of wine with 10° of alcohol = 12 g, or 1 glass (4 cl) of aperitif with 42° of alcohol = 17 g). 17. Subjects who smoke more than 10 cigarettes or equivalent/day. Smoking or any use of tobacco will not be allowed while attending the sleep lab. 18. Positive test result on hepatitis B surface antigen, hepatitis C antibody. 19. A positive test for HIV-1, HIV-2. 20. Excessive daily consumption of xanthine containing drinks (i.e > 500 mg/day of caffeine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the hypnotic effects on sleep initiation by PSG of a single dose of sublingual zolpidem (Sublinox) versus oral immediate-release zolpidem (Ambien IR) in patients with primary insomnia. The primary endpoint will be Latency to persistent Sleep (LPS) (to test for superiority). Secondary endpoints will be Sleep Onset Latency (SOL) and Latency to Stage 1 (ST1L). - To evaluate the hypnotic effects on sleep continuity by PSG of a single dose of sublingual zolpidem (Sublinox) versus oral immediate-release zolpidem (Ambien IR) in patients with primary insomnia. The following PSG variables will be tested for “at least as good as”: Total Sleep Time (TST), Number and duration of awakenings after sleep onset (WASO). ;Secondary Objective: - To evaluate by PSG other visually scored night sleep variables, other latency variables, sleep continuity and sleep architecture of sublingual zolpidem (Sublinox) versus oral immediate-release zolpidem (Ambien IR) in patients with primary insomnia. - To evaluate the patient’s subjective assessment of sleep and next day residual effects of sublingual zolpidem (Sublinox) versus oral immediate-release zolpidem (Ambien IR) in patients with primary insomnia. - To assess tolerability and safety of the study treatments.;Primary end point(s): Latency to persistent Sleep (LPS) | — |
Countries
Belgium
Outcome results
None listed