Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of ramelteon, once daily (QD),
      combined with doxepin in treating subjects with insomnia.
    

Detailed description: 
      Approximately 60 to 70 million adults in the United States alone are affected by insomnia.
      Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and
      irritability. Recent epidemiologic research focusing on quality of life has identified
      significant insomnia-related morbidities that relate to work productivity, health care
      utilization, and risk of depression. Insomnia is also associated with diminished work output,
      absenteeism, and greater rates of accidents. Gamma-aminobutyric acid is the major inhibitory
      transmitter in the central nervous system and most currently prescribed sleep agents are
      benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine
      receptor site of the gamma-aminobutyric acid -A receptor complex. In addition to sleep,
      benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly
      related to sleep, including sedative, anxiolytic, muscle-relaxant, and amnesic effects, and
      have risks of tolerance, dependence, and abuse potential.

      Doxepin is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic
      compounds. Doxepin is indicated for the treatment of depression, anxiety, and psychotic
      depressive disorders. The most common adverse event associated with the use of doxepin is
      drowsiness. A limited number of controlled studies have been performed to examine the effects
      of low doxepin on insomnia.

      TAK-375 (Ramelteon) is a melatonin receptor agonist with affinity for the human melatonin
      receptor subtype 1 (MT1), melatonin receptor subtype 2 (MT2) and selectivity over the
      melatonin receptor subtype 3 (MT3) receptor.

      This trial will determine if the co-administration of ramelteon and doxepin will decrease
      both latency to persistent sleep and wake time after sleep onset. Study participation is
      anticipated to be about 2 months.
    

Intervention name(s): Ramelteon and doxepin; Ramelteon; Doxepin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.; Ramelteon 8 mg, tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.; Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.; Ramelteon placebo-matching tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.
Other intervention name(s): Rozerem™; TAK-375; Sinequan®; ramelteon; Rozerem™; TAK-375; Sinequan®
Intervention MeSH terms: Doxepin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Insomnia; DIMS (Disorders of Initiating and Maintaining Sleep); Disorders of Initiating and Maintaining Sleep; Insomnia Disorder Sleep Initiation Dysfunction; Transient Insomnia; Drug Therapy; Sleep Disorders, Intrinsic