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What is the primary objective of this study?

The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia.

Who is eligible to participate?

Inclusion Criteria: 1. age between 18 years to 69 years 2. fluent in German language 3. provide written informed consent 4. ability to understand the explanations and instructions given by the study physician and the investigator Exclusion Criteria: 1. Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia) 2. Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history - allergies to amitriptyline hydrochloride or any of its ingredients - allergies to zolpidem or any of its ingredients - acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug - urinary retention - delirium - untreated closed-angle glaucoma - prostatic hyperplasia - pyloric stenosis - paralytic ilius - suicidal thoughts - liver/ kidney/ pulmonary insufficiency - myasthenia gravis - hypokalemia - bradycardia - coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders - increased risk of seizures/ history of seizures - substance dependence syndrome/ history of substance dependence syndrome 3. Allergies to ingredients of placebo or novel-tasting drink (CS) 4. currently pregnant (verified by urine pregnancy test) or lactating 5. patients scoring ≥12 on the Epworth Sleepiness Scale 6. patients scoring below 8 or above 21 on the Insomnia Severity Index 7. patients suffering from a mental disorder as verified by the SCID (major depression; psychosis; brain injury; substance abuse or dependency syndrome during the last 6 months before V1) 8. nicotine consumption > 10 cigarettes/day 9. unwillingness to refrain from alcohol consumption throughout the study 10. Concomitant medication interfering with study medication intake due to potential interactions (all psychotropic medication including analgetics and muscle relaxants, hypericum derivatives; antihypertensives; anti-arrhythmic agents; antibiotics; cisaprid; anti-malaria drugs; diuretics; imidazole antifungals; cumarin derivatives; antihistaminics; calcium channel blockers; medications that enlarge the QT interval or may lead to hypokalemia) 11. change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization 12. intake of psychotropic medication during the last 3 months 13. participation in any other clinical trial 3 months prior to visit 1 14. women of childbearing age not using 2 highly effective contraceptive methods 15. employee of the Sponsor or the principal investigator

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Amitriptyline50 mg capsule amitriptyline before going to bed on 8 out of 17 nights

Drug:Zolpidem5 mg capsule zolpidem before going to bed on 8 out of 17 nights

Drug:Amitriptyline50 mg capsule amitriptyline before going to bed on 13 out of 17 nights

Drug:PlaceboPlacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Amitriptyline flexible dosing50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo

Zolpidem flexible dosing5 mg capsule zolpidem before going to bed on 8 out of 17 nights/placebo

Amitriptyline fixed dosing50 mg capsule amitriptyline before going to bed on 8 out of 17 nights

Zolpidem fixed dosing5 mg capsule zolpidem before going to bed on 8 out of 17 nights

Amitriptyline continuous dosing50 mg capsule amitriptyline before going to bed on 13 out of 17 nights

Study Status

Terminated

Start Date: May 2014

Completed Date: November 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Objective Total Sleep Time

Secondary Outcome: Percentage of REM sleep

Study sponsors, principal investigator, and references

Principal Investigator: Winfried Rief, Prof. Dr.

Lead Sponsor: Philipps University Marburg Medical Center

Collaborator: Johannes Gutenberg University Mainz

More information:https://clinicaltrials.gov/show/NCT02139098