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A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Insomnia

Treatments

Drug: Dose-matched Placebo to Suvorexant
Drug: Suvorexant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01021813
4305-009
2009_696 (Other Identifier)

Details and patient eligibility

About

This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.

Enrollment

781 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of primary insomnia
  • Participant is able to read, understand, and complete questionnaires and diaries
  • If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
  • If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Exclusion criteria

  • If female, participant is pregnant
  • Participant expects to donate eggs or sperm during the study
  • Recent and/or active history of a confounding neurological disorder
  • History of clinically unstable cardiovascular disorder within the last 6 months
  • Lifetime history of bipolar disorder
  • Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study
  • History of substance abuse/dependence
  • History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item ([QIDS-SR16] suicide item #12)
  • Participant has travelled across >3 time zones or >3 hour time difference in the last 2 weeks
  • History of permanent night shift work or rotating day/night shift work in the past 2 weeks
  • Body Mass Index (BMI) >40 kg/m^2

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

781 participants in 2 patient groups, including a placebo group

Suvorexant
Experimental group
Description:
After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase.
Treatment:
Drug: Dose-matched Placebo to Suvorexant
Drug: Suvorexant
Placebo
Placebo Comparator group
Description:
After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the Treatment Phase.
Treatment:
Drug: Dose-matched Placebo to Suvorexant

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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