A double-blind, randomised, two-period crossover study to evaluate the hypnotic effects and safety of sublingual zolpidem for the treatment of insomnia.

• Conditions: Primary insomnia; MedDRA version: 8.1Level: LLTClassification code 10036701Term: Primary insomnia

• Registration Number: EUCTR2006-005711-10-BE
• Lead Sponsor: Orexo AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-14
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

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 < 6.5 h, a duration of WASO > 30 min and a LPS of >= 20 minutes with a mean LPS greater than 30 min. No LPS <20 min and (LPS1+LPS2)/2 >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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified