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Daridorexant at Midlife: What the Menopause-Age Subgroup Shows

The subgroup findings, current trial status and prescribing precautions.

A woman with short auburn hair discusses a sleep notebook with a clinician beside a window.
In this article
  1. Was this a trial specifically enrolling women with menopause-related insomnia?
  2. What did 50 mg change compared with placebo?
  3. What is the dedicated menopause study testing?
  4. Does the subgroup remove next-morning precautions?
  5. What should I bring to the appointment?

A study of women in their late forties and early fifties can inform a sleep consultation. Before applying its findings to menopause-related insomnia, check how the women were selected and how precise the results were.

The 2026 report analyzed 117 women aged 47–55 from a three-month insomnia trial: 35 on 50 mg, 43 on 25 mg and 39 on placebo. Selection was by age, rather than menopause-related insomnia.1

What did 50 mg change compared with placebo?

Adjusted month-three estimates, with 95% confidence intervals, were:1

  • Laboratory-measured waking after sleep onset: 13.8 fewer minutes (29.0 fewer to 1.4 more).
  • Laboratory-measured time to persistent sleep: 14.7 fewer minutes (30.0 fewer to 0.6 more).
  • Diary-reported sleep: 21.8 more minutes (3.9 fewer to 47.4 more).
  • Total daytime symptom/impact score: 4.1 points lower (14.4 lower to 6.3 higher).

Every interval includes zero difference. These estimates favor treatment but remain compatible with no benefit; they do not prove no benefit. Three authors were Idorsia employees.1

What is the dedicated menopause study testing?

CELESTE compares digital cognitive behavioral therapy for insomnia, trazodone and daridorexant, with treatment or program access over 12 months. Its primary outcome is a patient-reported sleep-disturbance score at six months.2

The registry update posted June 8, 2026, checked October 16, lists recruiting, 1,000 planned participants and no posted results. Eligibility includes ages 40–62, peri- or early menopause, and insomnia that started or worsened during that transition, alongside further screening requirements. This study cannot yet tell a reader which option performed best.2

Does the subgroup remove next-morning precautions?

The US QUVIVIQ label covers adult insomnia involving difficulty falling or staying asleep. It requires at least seven hours before planned awakening and warns about next-day impairment, including driving. Alcohol adds impairment risk; narcolepsy is a contraindication. If complex sleep behavior such as sleepwalking occurs, the label calls for immediate discontinuation.3

Our daridorexant driving-study explanation examines that separate evidence. Feeling less sleepy and having unimpaired driving performance are different outcomes.

What should I bring to the appointment?

Write down whether your main difficulty is falling asleep, repeated waking or functioning the next day. Bring your medicine list and a practical treatment goal, such as staying awake through the morning commute without struggling.

“Medicines Belong in Shared Decisions” in Did I Do That in My Sleep? frames the discussion around expected benefit, adverse effects, interactions, next-day impairment, cost and a review plan. Ask which evidence applies to your situation and when you will reassess the chosen treatment.

Discuss insomnia treatment and medicine interactions with your clinician. Research doses are not personal prescribing instructions.

Read our health disclaimer

Girl Playbook sells this book. It provides education and worksheets, not individualized medical care.

Sources

The research behind this article, in the order it’s cited. How we source our articles.

  1. Schaedel et al., Maturitas, 2026Daridorexant subgroup analysis in women aged 47–55 (opens in a new tab)abc
  2. ClinicalTrials.gov, Brigham and Women's Hospital, 2026CELESTE study registration, NCT07136415 (opens in a new tab)ab
  3. DailyMed, Idorsia PharmaceuticalsQUVIVIQ US prescribing information (opens in a new tab)↩

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